阅读说明：本技术 用于检测危险污染物的采样系统和技术 (Sampling systems and techniques for detecting hazardous contaminants ) 是由 M·奥辛斯基 C·桑德曼 A·J·麦金农 于 2020-03-18 设计创作，主要内容包括：某些方面涉及用于危险污染检测设备的系统和使用技术,其可结合测定件(诸如横向流测定件)的光学分析来利用位置特定机器可读信息标签以实现污染检测数据和/或趋势的增强的可靠性和分析。粘贴到测试位置和/或测试样本容器的位置标签提供了一致和简化的测试工作流,用于可靠地获得和存储位置信息联合大量单独测试结果而不需要手动记录。危险污染检测设备可编程地实现两步测试工作流。(Certain aspects relate to systems and techniques for use with hazardous contamination detection equipment that may utilize location-specific machine-readable information tags in conjunction with optical analysis of a sensing member, such as a lateral flow sensing member, to enable enhanced reliability and analysis of contamination detection data and/or trends. The location tags affixed to the test locations and/or test specimen containers provide a consistent and simplified test workflow for reliably obtaining and storing location information in association with a large number of individual test results without the need for manual recordation. The hazardous contamination detection device programmably implements a two-step test workflow.)

1. A hazardous contamination detection apparatus, comprising:

a housing configured to receive an assay cartridge at least partially within the housing, the assay cartridge comprising an assay;

an optical sensor positioned within the housing to detect a change in an optical characteristic of the sensing member after application of a test sample to the sensing member, the optical sensor configured to generate a signal indicative of the detected change in the optical characteristic of the sensing member;

a first optical scanner configured to image first machine-readable data from an object outside the housing;

a second optical scanner within the housing configured to image second machine-readable data from the assay cartridge when the assay cartridge is at least partially received within the housing;

at least one processor; and

a memory having instructions stored thereon that configure the at least one processor to:

determining positional information identifying a test location corresponding to the assay cartridge based on the first machine-readable data imaged at the first optical scanner;

determining additional information associated with the assay based on the second machine-readable data imaged at the second optical scanner;

determining a test result based at least in part on the additional information and the signal generated by the optical sensor; and

automatically storing the test results in the memory in association with the location information.

2. The hazardous contamination detection device of claim 1, wherein the at least one processor is configured to use the additional information to establish operating parameters of the hazardous contamination detection device.

3. The hazardous contamination detection apparatus of claim 1, wherein the assay comprises a lateral flow assay, and wherein the signal generated by the optical sensor is indicative of a positive or negative result corresponding to the assay.

4. The hazardous contamination detection apparatus of claim 1, wherein the additional information identifies a contaminant that the sensing member is configured to detect.

5. The hazardous contamination detection apparatus of claim 1, wherein the sensing member is configured to detect the presence of one or more anti-tumor agents within a liquid sample applied to the sensing member.

6. The hazardous contamination detection device of claim 1, wherein the at least one processor is configured to store the additional information in association with the test results.

7. The hazardous contamination detection device of claim 1, wherein the additional information comprises at least one of: a time of development corresponding to the sensing member, an operating parameter of the hazardous contamination detection apparatus corresponding to the sensing member, and a name corresponding to a drug the sensing member is configured to detect.

8. The hazardous contamination detection apparatus of claim 1, further comprising a communication module configured for wireless data transmission, wherein the instructions further configure the at least one processor to cause the communication module to wirelessly transmit the test results in conjunction with the location information to a remote data storage device.

9. The hazardous contamination detection device of claim 1, wherein the first machine-readable data and the second machine-readable data each comprise a barcode, and wherein the first optical scanner and the second optical scanner each comprise a barcode scanner.

10. The hazardous contamination detection device of claim 1, further comprising a display and a sensor configured to detect insertion of the assay cartridge into the housing, wherein the instructions further configure the at least one processor to:

detecting insertion of the assay cartridge into the housing;

in response to detecting insertion of the assay cartridge, displaying instructions to a user for scanning the first machine-readable data at the first optical scanner; and

causing the first optical scanner to image the first machine-readable data.

11. The hazardous contamination detection device of claim 1, further comprising a sensor configured to detect insertion of the assay cartridge into the housing, wherein the instructions further configure the at least one processor to:

detecting insertion of the assay cartridge in the housing; and

causing the second optical scanner to image the second machine-readable data.

12. The hazardous contamination detection apparatus of claim 1, wherein the memory stores a comma separated values file (CSV file) containing values indicative of previously performed tests, and wherein storing the test results comprises editing the CSV file to add one or more values indicative of the test results and the location information.

13. The hazardous contamination detection apparatus of claim 1, wherein the first optical scanner is housed within a module removably received at least partially within the housing.

14. A method for location-specific testing for hazardous contaminants, the method comprising:

determining a plurality of test locations for hazardous contaminant testing;

generating a plurality of location-specific machine-readable information tags, each machine-readable information tag associated with one of the plurality of test locations;

collecting a first sample from a first test location of the plurality of test locations;

applying the first sample to a sensing element disposed within a first assay cartridge, the assay cartridge including additional machine-readable information identifying a contaminant that the sensing element is configured to detect;

inserting the first assay cartridge into a hazardous contamination detection apparatus;

scanning, at an optical scanner of the hazardous contamination detection equipment, a first location-specific machine-readable information label of the plurality of location-specific machine-readable information labels, the first location-specific machine-readable information label associated with the first test location; and

removing the first assay cartridge from the hazardous contamination detection device in response to an indication of a test result displayed by the hazardous contamination detection device.

15. The method of claim 14, further comprising:

collecting a plurality of second samples from a plurality of second test locations of the plurality of test locations;

applying the plurality of second samples to individual assay components disposed within a second assay cartridge;

inserting a separate second assay cartridge into the hazardous contamination detection apparatus; and

scanning, for each individual second assay cartridge, an individual second location-specific machine-readable information label of the plurality of location-specific machine-readable information labels, each second location-specific machine-readable information label associated with a second test location corresponding to the individual second sample applied to the second assay cartridge.

16. The method of claim 15, wherein collecting the plurality of second samples comprises placing each second sample into an individual sample container, the method further comprising, prior to inserting the individual second assay cartridge into the hazardous contamination detection device, affixing the individual second location-specific machine-readable information labels to the individual sample containers, wherein each individual second location-specific machine-readable information label is scanned after the second samples contained therein have been at least partially transferred to an individual second assay cartridge.

17. The method of claim 16, wherein affixing each individual second location-specific machine-readable information comprises obtaining one of a plurality of substantially identical labels stored at or near the corresponding second testing location, and affixing the obtained label to the individual sample container.

18. The method of claim 16, wherein the individual second location-specific machine-readable information labels are affixed to second sample containers at label storage locations remote from at least some of the plurality of test locations.

19. The method of claim 15, wherein the hazardous contamination detection device is a portable device, wherein each first or second assay cartridge is inserted into the hazardous contamination test device at or near one of the plurality of test locations, and wherein for each first or second assay cartridge, the scanning comprises scanning a machine-readable information label affixed to a surface at or near one of the plurality of test locations.

20. The method of claim 14, wherein scanning the first location-specific machine-readable information tag causes, at least in part, the hazardous contamination detection equipment to optically analyze the test piece to determine a test result, and append the determined test result and a test location identifier to a Comma Separated Values (CSV) file stored in a memory of the hazardous contamination detection equipment.

21. The method of claim 14, wherein collecting the first sample comprises obtaining a liquid sample and storing the liquid sample within a sample container, the method further comprising affixing the first location-specific machine-readable information label to the sample container.

Technical Field

The systems and methods disclosed herein relate to environmental contamination testing, and more particularly to systems and apparatus for efficient multi-point contamination testing and tracking.

Background

Antineoplastic drugs are used to treat cancer and are most commonly found in small molecule (e.g., fluorouracil) or antibody formats (e.g., rituximab). The detection of antineoplastic drugs is critical to determining whether contamination or leakage exists in the areas where the drugs are used and/or dispensed, such as hospitals and pharmacy areas.

The nature of antineoplastic drugs makes them harmful to both healthy cells and tissues as well as cancer cells. Precautions should be taken to eliminate or reduce occupational exposure of healthcare workers to antineoplastic drugs. The pharmacists who formulate these drugs, as well as the nurses who may formulate and manage these drugs, are the two professions who are the highest possible exposure to antineoplastic drugs. In addition, physicians and operating room personnel may also be exposed through treatment of patients, as patients treated with antineoplastic drugs may be discharged of these drugs. Hospital staff such as transportation and receiving personnel, custody staff, laundry staff and waste disposal personnel are all likely to be exposed to these medications during their work process. The increased use of antineoplastic drugs in veterinary oncology also exposes these workers to the risk of exposure to these drugs.

Disclosure of Invention

The antineoplastic agent is antiproliferative. In some cases, they influence the process of cell division by destroying DNA and initiating apoptosis, a form of programmed cell death. While this may be desirable to prevent the development and spread of tumor cells (e.g., cancer cells), anti-tumor drugs may also affect rapidly dividing non-cancer cells. Thus, antineoplastic drugs may inhibit healthy biological functions, including bone marrow growth, healing, hair growth, and fertility, to name a few.

Studies have correlated workplace exposure to antineoplastic drugs with health effects such as skin rashes, hair loss, infertility (both temporary and permanent), effects on reproductive and fetal development in pregnant women, increased genotoxic effects (e.g., destructive effects on genetic material that can lead to mutations), hearing disorders, and cancer. These health risks are affected by the extent of exposure and the efficacy and toxicity of the hazardous drugs. While the potential therapeutic benefit of hazardous drugs may outweigh the risk of developing such side effects for the patient, exposed health care workers risk these same side effects without therapeutic benefit. Furthermore, it is understood that even exposure to extremely small concentrations of antineoplastic drugs can be dangerous to workers handling or working in the vicinity of these drugs, and that there is no safe level of exposure to known carcinogens.

Environmental sampling can be used to determine the level of workplace contamination caused by antineoplastic agents. However, sampling and decontamination of contaminated areas is complicated by the lack of a fast, inexpensive method for first identifying these areas and then determining the level of success of decontamination. While analytical methods are available for testing environmental samples for the presence of antineoplastic drugs, these methods require transport to an external laboratory, thereby delaying the receipt of the sample results.

In one example sampling system suitable for use with the apparatus of the present disclosure, a work surface may be tested for the presence of anti-neoplastic agents in the environment. The test results can be provided very quickly at the test site so that the operator of the test, other personnel in the area, and/or a remote system can be alerted to the presence and/or concentration of the anti-neoplastic agent in close temporal proximity to the test event (within 1-2 minutes in some cases). The method of testing includes providing a buffer solution to a surface and wiping the wetted surface with an absorbent swab, or by wiping the surface with a swab pre-wetted with the buffer solution. The buffer fluid may have properties that aid in picking up contaminants from the surface. In some embodiments, the buffer fluid may have properties that aid in releasing the collected contaminants from the swab material. The collected contaminants can be mixed into a homogeneous solution for testing. The buffer solution, along with any collected contaminants, may be expressed or extracted from the swab to form a liquid sample. The fluid sample can be analyzed for the presence and/or amount of a particular antineoplastic agent. For example, the solution may be provided onto an assay (such as, but not limited to, a lateral flow assay) that is read by an assay reader device to identify the presence and/or concentration of contaminants in the liquid sample.

Testing for the presence and/or concentration of contaminants may be performed for several different locations within a facility. In some embodiments, it may be desirable to maintain and analyze historical data and/or trends regarding contaminant detection. For example, an operator may wish to track the increase or decrease of contaminants subdivided over time, detected within the entire facility, and/or by subsets of locations, by individual contaminant processors, by individual contaminant detection testers, and the like. Existing sampling systems require manual recording, which can be cumbersome and inefficient when implemented in relatively large facilities with a large number of individual test locations. This approach has a number of disadvantages, including being relatively time consuming, prone to record keeping or data entry errors, and increasing the risk of exposure of the test operator to potentially hazardous drug contamination by increasing the amount of time the test operator must spend handling potentially hazardous samples.

These and other problems are addressed in embodiments of a hazardous drugs collection and detection system described herein that includes a location-specific machine-readable information tag and a diagnostic device configured to determine location information based on the machine-readable information tag. The machine-readable information label may be applied to the specimen collection container and/or may be located at or near a separate testing location. The label can be scanned at the time of sample collection and/or at the time of testing to ensure that each sample test result is stored in association with an accurate location identifier. Thus, the present techniques provide improved accuracy for tracking and analyzing samples to detect the presence or absence of hazardous contaminants and, in some cases, hazardous drug concentrations. The disclosed detection system may advantageously enable more efficient and accurate analysis, classification, and response of detected contamination events.

Accordingly, one aspect relates to a hazardous contamination detection apparatus, comprising: a housing configured to receive an assay cartridge at least partially within the housing, the assay cartridge comprising a sensing element; an optical sensor positioned within the housing to detect a change in an optical characteristic of the sensing member after application of the test sample to the sensing member, the optical sensor configured to generate a signal indicative of the detected change in the optical characteristic of the sensing member; a first optical scanner configured to image first machine-readable data from an object outside the housing; a second optical scanner within the housing configured to image second machine-readable data from the assay cartridge when the assay cartridge is at least partially received within the housing; at least one processor; and a memory having instructions stored thereon. The instructions configure the at least one processor to: determining positional information identifying a test location corresponding to the assay cartridge based on first machine-readable data imaged at the first optical scanner; determining additional information associated with the assay based on second machine-readable data imaged at the second optical scanner; determining a test result based at least in part on the additional information and the signal generated by the optical sensor; and automatically storing the test results in a memory in association with the location information.

In some embodiments of the hazardous contamination detection apparatus, the at least one processor is configured to use the additional information to establish operating parameters of the hazardous contamination detection apparatus.

In some embodiments of the hazardous contamination detection apparatus, the assay comprises a lateral flow assay, and the signal generated by the optical sensor is indicative of a positive or negative result corresponding to the assay.

In some embodiments of the hazardous contamination detection apparatus, the additional information identifies a contaminant that the sensing member is configured to detect.

In some embodiments of the hazard detection apparatus, the probe is configured to detect the presence of one or more anti-tumor agents within a liquid sample applied to the probe.

In some embodiments of the hazardous contamination detection apparatus, the at least one processor is configured to store the additional information in association with the test results.

In some embodiments of the hazardous contamination detection apparatus, the additional information comprises at least one of: a development time corresponding to the assay, an operating parameter of the hazardous contamination detection apparatus corresponding to the assay, and a name corresponding to a drug the assay is configured to detect.

Some embodiments of the hazardous contamination detection apparatus further comprise a communication module configured for wireless data transmission, and the instructions further configure the at least one processor to cause the communication module to wirelessly transmit the test results in conjunction with the location information to a remote data storage device.

In some embodiments of the hazardous contamination detection apparatus, the first machine-readable data and the second machine-readable data each comprise a barcode, and wherein the first optical scanner and the second optical scanner each comprise a barcode scanner.

Some embodiments of the hazardous contamination detection apparatus further comprise a display and a sensor configured to detect insertion of the assay cartridge into the housing, and the instructions further configure the at least one processor to: detecting insertion of the cartridge into the housing; in response to detecting insertion of the assay cartridge, displaying instructions to a user for scanning the first machine-readable data at the first optical scanner; and causing the first optical scanner to image the first machine-readable data.

Some embodiments of the hazardous contamination detection apparatus further comprise a sensor configured to detect insertion of the assay cartridge into the housing, and the instructions further configure the at least one processor to: detecting insertion of the cartridge into the housing; and causing the second optical scanner to image the second machine-readable data.

In some embodiments of the hazardous contamination detection apparatus, the memory stores a Comma Separated Values (CSV) file containing values indicative of previously performed tests, and storing the test results includes editing the CSV file to add one or more values indicative of the test results and the location information.

In some embodiments of the hazardous contamination detection apparatus, the first optical scanner is housed within a module that is removably received at least partially within the housing.

Another aspect relates to a method for location-specific testing for hazardous contaminants, the method comprising: determining a plurality of test locations for hazardous contaminant testing; generating a plurality of location-specific machine-readable information tags, each machine-readable information tag associated with one of a plurality of test locations; collecting a first sample from a first test location of a plurality of test locations; applying the first sample to an assay component disposed within a first assay cartridge, the assay cartridge including additional machine-readable information identifying a contaminant that the assay component is configured to detect; inserting the first assay cartridge into a hazardous contamination detection apparatus; scanning a first location-specific machine-readable information label of the plurality of location-specific machine-readable information labels at an optical scanner of the hazardous contamination detection equipment, the first location-specific machine-readable information label associated with a first test location; and removing the first assay cartridge from the hazardous contamination detection device in response to the indication of the test result displayed by the hazardous contamination detection device.

Some embodiments of the method further comprise collecting a plurality of second samples from a plurality of second test locations of the plurality of test locations; applying a plurality of second samples to individual assay components disposed within a second assay cartridge; inserting a separate second assay cartridge into the hazardous contamination detection apparatus; and scanning, for each individual second assay cartridge, an individual second location-specific machine-readable information label of the plurality of location-specific machine-readable information labels, each second location-specific machine-readable information label associated with a second test location corresponding to an individual second sample applied to the second assay cartridge. In some further embodiments of the method, collecting the plurality of second samples comprises placing each second sample into an individual sample container, the method further comprising, prior to inserting the individual second assay cartridge into the hazardous contamination detection device, affixing an individual second location-specific machine-readable information label to the individual sample container, wherein each individual second location-specific machine-readable information label is scanned after the second samples contained therein have been at least partially transferred to the individual second assay cartridge. In some further embodiments of the method, affixing each individual second location-specific machine-readable information comprises obtaining one of a plurality of substantially identical labels stored at or near the corresponding second testing location, and affixing the obtained label to an individual sample container. In some further embodiments of the method, a separate second location-specific machine-readable information label is affixed to the second specimen container at a label storage location remote from at least some of the plurality of testing locations. In some further embodiments of the method, the hazardous contamination detection device is a portable device, wherein each first or second assay cartridge is inserted into the hazardous contamination testing device at or near one of the plurality of test locations, and wherein for each first or second assay cartridge, scanning comprises scanning a machine-readable information label affixed to a surface at or near one of the plurality of test locations.

In some embodiments of the method, scanning the first location-specific machine-readable information tag causes, at least in part, the hazardous contamination detection equipment to optically analyze the test piece to determine a test result, and append the determined test result and the test location identifier to a Comma Separated Values (CSV) file stored in a memory of the hazardous contamination detection equipment.

In some embodiments of the method, collecting the first sample comprises obtaining a liquid sample and storing the liquid sample in a sample container, the method further comprising affixing a first location-specific machine-readable information label to the sample container.

Drawings

The disclosed aspects will hereinafter be described in conjunction with the appended drawings, provided to illustrate and not to limit the disclosed aspects, wherein like designations denote like elements.

FIG. 1A illustrates an example hazardous contamination detection facility.

FIG. 1B illustrates an example assay cartridge compatible with the hazardous contamination detection equipment of FIG. 1A.

FIGS. 1C and 1D further illustrate an example apparatus for obtaining a sample for analysis at the hazardous contamination detection apparatus of FIG. 1A.

FIG. 2 schematically illustrates an example medical facility in which the disclosed hazardous contamination detection systems and methods may be implemented.

FIG. 3 shows a schematic block diagram of an example hazardous contamination detection apparatus.

FIG. 4 is a flow chart depicting an example operational procedure of a hazardous contamination detection apparatus as disclosed herein.

FIG. 5 is a flow chart depicting an example process for conducting location-specific tests using a hazardous contamination detection apparatus as described herein.

Fig. 6 illustrates various examples of display text that may be presented to an operator on a display screen of an assay reader device as described herein.

Fig. 7A-7D schematically illustrate example embodiments of location-specific hazardous contamination testing for multiple test locations within a facility.

Fig. 7E-7H illustrate example configurations for providing location-specific machine-readable information tags compatible with the embodiments of fig. 7A-7D.

Fig. 8A-8C illustrate example reports generated in accordance with the location-specific hazardous contamination detection systems and methods described herein.

Detailed Description

Introduction to

Embodiments of the present disclosure relate to systems and techniques for a hazardous contaminant assay reader device that may include a scan-in device for receiving location information and automatically associating the location information with a determined test result. Embodiments of the reader device may be portable, e.g., relatively small and light, and may choose to deplete stored power. The disclosed reader device may be used in hospitals, clinics, doctors and veterinary offices, and any treatment, nursing or pharmaceutical processing facility where hazardous substances, such as, but not limited to, antineoplastic agents, are present, to enable rapid detection, classification and tracking of hazardous contaminants. The network connection module and/or manual data retrieval may enable standardization, tracking, and electronic connection of test results from reader devices located throughout the network to improve hazardous material handling.

The assay reader device can be a two-step device in which the user need only apply the sample and scan the location-specific machine-readable information tag before reviewing the results and optionally transmitting the results to the appropriate database. Such a two-step apparatus may avoid the necessity of performing complex and time-consuming processing steps that may introduce errors in the final result. For example, a user may press a single button on the assay reader device to power on the device. Thereafter, inserting the sample cartridge into the device may trigger an instruction to scan the positional barcode; scanning the location barcode may automatically activate a reading process to determine and display test results based on a previously inserted sample cartridge without further user input. The location information may be received by scanning a location-specific label (e.g., affixed to a sample container) at a reader device. The location label affixed to each sample container allows the user to reliably scan the correct location label corresponding to the location from which the sample was obtained without requiring the user to remember where to obtain individual samples, and still allows the user to collect a large number of samples in a single pass around the facility rather than having to return to the detector location after each sample is obtained. In some embodiments with network connectivity capabilities, the determined test results may additionally be automatically sent to a remote storage device (e.g., to a centralized database) without further user input. In some embodiments with network connectivity, the determined test results may be sent directly to a designated clinician or database. In some embodiments, the device may store each determined test result and associated location identifier in memory, such as by adding one or more values to a Comma Separated Values (CSV) file that stores previous test results and associated location identifiers.

One example of a device operating mode is an endpoint read mode. In the endpoint reading mode, the user prepares and incubates the measurement piece outside the measurement analyzer device and tracks the development (maintenance) time of the measurement piece. For example, a test piece configured to determine the presence or absence of a hazardous drug may have a 10 minute development time, so the user would apply the sample to the test piece and wait 10 minutes. At the end of the 10 minutes, the user would insert a probe into the assay analyzer device to obtain the test results. Thus, when operating in an endpoint reading mode, the assay analyzer device can provide instructions, e.g., audibly or on a visual display, that instruct a user to wait a predetermined time after applying a sample to the assay before inserting the assay into the assay analyzer device. In other embodiments, when operating in an endpoint reading mode, the assay analyzer device may not display any instructions, but may simply read the assay after insertion into the assay analyzer device. After the assay is inserted into the assay analyzer apparatus, an optical reader of the apparatus may collect image data representing the assay for analysis in determining the results of the assay. In some embodiments, the endpoint reading mode may be a default operating mode of the assay analyzer device.

Another example of a device operating mode is a walk-away (walkaway) mode. Thus, when operating in the walk-away mode, the assay analyzer device can provide instructions for a user to insert an assay immediately after application of a sample or during application of a sample. In a walk-away mode according to one embodiment, a user can apply a sample to a probe and immediately insert the probe into the assay analyzer device. The probe will develop in the assay analyzer device and the assay analyzer device can track the time elapsed since the probe was inserted. At the end of the predetermined development time, the assay analyzer device may collect image data representing the assay, analyze the image data to determine a test result, and report the test result to the user. The assay development time may be unique for each test, for example the first contaminant assay development time may be 10 minutes and the second contaminant assay development time may be 5 minutes. In some embodiments, the walk-away mode may be set by double-clicking a single button of the assay analyzer device. A further input may indicate to the reader device the time of development of the assay. For example, a bar code scanned by a bar code reader or provided on the sensing member or on a cassette for receiving the sensing member may indicate to the device the type of sensing member inserted and the development time of the sensing member. Based on the type of probe, the probe analyzer device may wait a predetermined amount of time after sample application and insertion before collecting image data representative of the probe.

In embodiments of the assay analyzer device described herein, there are a number of advantages associated with the ability of a user to select and switch between device operating modes. The endpoint reading mode is convenient in large laboratory or medical practice facilities where personnel typically batch process many tests. The walk-on mode may be useful when a single test is performed, or when the end user does not want to have to track assay development time (or does not know how to accurately track assay development time or has not received training regarding it). The walk-away mode may advantageously reduce or eliminate the occurrence of incorrect test results due to a sensing member being inserted and imaged too quickly (too early before the time of development of the sensing member has elapsed) or too slowly (too long after the time of development of the sensing member has elapsed). Further, in the walk-away mode, the assay reader is operable to capture a plurality of images of the assay at predetermined time intervals, such as when a motion profile of assay readings is desired.

One embodiment of the disclosed assay analyzer device (such as the basic assay reader device described in detail below) includes only a single button on its external housing, such as a single power button that powers down and up the assay analyzer device. Embodiments of the disclosed assay analyzer device also implement two different device operating modes (although more than two device operating modes are possible). To enable the end user to select and switch between the two device operating modes, the assay analyzer device may include instructions for implementing a double-click function on the power button. Insertion of the assay cartridge may automatically trigger the endpoint reading mode after receiving input of a single press of a button to power up the device. When the processor of the device receives an input from the user double-clicking the power button, this may initiate the stored instructions to implement the walk-away mode. This double click functionality provides a simple and intuitive way for an end user to switch between different operating modes of the assay analyzer device. The double-click functionality also enables the user to configure the device in real-time to operate in a walk-off mode without requiring the user to perform any additional configuration steps or additional programming of the assay analyzer device. It will be appreciated that the assay analyzer device may be provided with instructions for recognizing other click patterns (e.g., recognizing that a user presses a button any predetermined number of times, presses a button in a predetermined pattern, and/or presses and holds a button for a predetermined length of time) in lieu of or in addition to double-clicking to trigger an auxiliary (non-default) device operating mode.

As described above, examples of barcode usage include providing additional data for use in conjunction with test result data, including location information, test type, device operating mode, sample information, and any other additional tests or test location information related to the test performed by the device. Some barcodes may unlock device functionality. Some barcodes may provide or update various types of information that the device uses to analyze the test piece, determine the test results, or perform a function. For example, the scanned bar code may provide the reader device with the test piece or reader calibration information that is useful or necessary to perform the test. In embodiments where the device does not have a wireless network connection, the test results may be stored in a memory of the reader device, and to access the stored test results, the user may scan the password barcode using a barcode scanner associated with the reader device.

Although the disclosed devices are generally described herein as assay reader devices, it will be understood that the modular system design and network connectivity aspects described herein may be implemented in any suitable hazardous contaminant detection device. For example, features described herein may be implemented in a reader device that analyzes other types of assays (such as, but not limited to, molecular assays) and provides test results. In other examples, the collected fluid is passed to a centrifuge, spectrometer, chemical detector, or other suitable testing device to determine the presence and/or concentration of one or more hazardous substances in the sample. Thus, embodiments of systems and methods of collecting, testing, and tracking collected samples according to the present disclosure may be implemented in these and other types of testing systems, and are not limited to the immunoassay testing systems described herein.

For purposes of illustration, various embodiments are described below in conjunction with the following figures. It should be understood that many other embodiments of the disclosed concept are possible and that various advantages can be realized by the disclosed embodiments.

Overview of example assay reader devices and operations

FIG. 1A illustrates an example hazardous contamination detection apparatus 100. The hazardous contamination detection device 100 includes an external scanning module 110 and an assay reader device 130. In some embodiments, the external scanning module can be an interchangeable module that is lockably inserted into a recess of the assay reader device 130. The assay cartridge 140, further shown in FIG. 1B, includes an assay piece 144 for insertion into a hazardous contamination detection apparatus. Fig. 1C shows a user obtaining a liquid sample at a test location for analysis by the hazardous contamination detection apparatus 100. FIG. 1D shows a user applying a liquid sample from a sample container 155 to a assay in the assay cartridge 140.

The hazardous contamination detection device 100 includes an external optical scanner 122, a cassette receiving aperture 134, a display 136, and a button 138. The external optical scanner may be, for example, a bar code scanner or any other scanner capable of imaging or otherwise scanning or detecting machine-readable or human-readable information. In some embodiments, hazardous contamination detection apparatus 100 also includes an internal optical scanner (not visible in fig. 1A) positioned to read bar code 142 or other machine-readable or human-readable information printed on cassette 140 or otherwise affixed to cassette 140 when the cassette has been inserted into cassette receiving aperture 134. The cartridge receiving aperture 134 may be sized and shaped to align a test area of a test piece with a detector or detector array disposed within the hazardous contamination detection apparatus 100 when the assay cartridge 140 is inserted through the cartridge receiving aperture 134. For example, if the test member is a lateral flow assay test strip, the test zone may include one or more of a control zone and a test zone having an immobilized compound capable of specifically binding the target analyte. The hazardous contamination detection apparatus 100 may implement an adaptive reading technique to improve the specificity of the test results and reduce false positive results by compensating for background and non-specific binding. The hazardous contamination detection apparatus 100 can be configured for rapid and accurate assay performance. This can facilitate rapid detection of the presence of one or more hazardous contaminants in a facility and facilitate testing and action methods for mitigating hazardous contamination.

The display 136 of the hazardous contamination detection device 100 may be an LED, LCD, OLED, or other suitable digital display, and may implement touch sensitive technology in some embodiments. The button 138 may be a mechanical button for energizing the hazardous contamination detection device 100. As described above, the hazardous contamination detection device 100 may include instructions for recognizing a pressing mode of the single button 138 in order to select a device operating mode. In some embodiments, the hazardous contamination detection device 100 may be powered on and ready for automatic use when plugged in or otherwise energized, and thus the button 138 may be omitted. In other embodiments, multiple buttons may be provided on the hazardous contamination detection apparatus 100. The assay reader device may also include a processor and at least one memory, as discussed in more detail below. The hazardous contamination detection device 100 may be data storage and print enabled.

The external optical scanner 122 may include one or more photodetectors and optional light emitting devices, such as for reading bar codes or other machine readable information. For example, one embodiment of the external optical scanner 122 may include a light source, a lens for focusing the light source on the object, and a photosensor for receiving light reflected from the object and converting the received light into an electrical signal. Some embodiments of the sensor of the external optical scanner 122 may include an array of many tiny light sensors such that the voltage pattern generated by the array is substantially the same as the pattern in the bar code. The external optical scanner 122 may also include decoder circuitry or software for analyzing the image data provided by the sensor, identifying barcode patterns in the image data, determining content associated with the barcode patterns, and outputting the content to, for example, a processor of the assay reader device.

In some embodiments, an external optical scanner 122 may be used to scan the location-specific machine-readable information labels. The machine-readable information label may include location information, such as, for example, a location identifier encoded in a barcode or other format, which may be scanned and stored in conjunction with the test results to ensure a high level of traceability and quality control via customizable file functions, data storage/download, and printing capabilities, while reducing the risk of manual transcription and error. As used herein, traceability may refer to the ability to verify location, time, personnel, patient, or other information associated with a test performed using a reader device by documenting the information. The documented information may be advantageously accessed by many entities in many ways described herein. As described above, an external optical scanner may be used to input test-related data, change device settings, unlock data access or other features, or change device modes. The test-related data may include test location, user ID, clinician or test administrator ID, sample ID, and test kit lot and/or expiration date, as well as other test-related information described herein. The multiple modes of operation of the hazardous contamination detection apparatus 100 provide a flexible workflow implemented via barcode scanning.

In some embodiments, the hazardous contamination detection equipment 100 may allow an end user to configure preset functions, such as whether the operator is required to enter information about the identity of the operator at the beginning of each test or test set. For example, the preset function may require the operator to scan the operator ID barcode at the beginning of each test event. The configuration of these preset functions may be accomplished by scanning a configuration barcode that, once decoded by the device, includes instructions for the preset function scan configuration. In one embodiment, a healthcare facility administrator may initially select one or more barcodes from a set of printed barcodes, the barcodes corresponding to the type of information required by the administrator for the desired configuration of a particular reader device; after this initial configuration selection, a user in the healthcare facility using a particular reader device may scan the appropriate barcode to enter information corresponding to the pre-selected function of the reader device. The reader device may transmit all available information related to the test to the centralized server, e.g., via a connection module or a wired connection to another computing device. In one embodiment, compliance (compliance) may not be enforced at the reader level and if the end user provides the operator ID via barcode scanning, this information will be transmitted with the test results, otherwise the operator ID field will be left empty. Other embodiments may prompt the end user for missing information. Local data storage, download, and print options may help ensure compliance and traceability if the reader does not have wireless or cellular connectivity.

The cassette 140 may house a probe 144 for proper alignment within the hazardous contamination detection equipment 100. As shown, the cassette 140 can include a window for exposing the test zone of the probe 144. The probe 144 may be a hazardous contaminant detection probe, for example, configured to detect the presence of an anti-neoplastic drug, such as, but not limited to, methotrexate or doxorubicin, or any other type of diagnostic test that can be optically imaged to determine the test results. The cartridge 140 may also include a bar code 142 or other machine readable information for providing test information (e.g., test type), which in some embodiments may be used to configure an automated process run by the hazardous contamination detection apparatus 100 for determining the results of the test piece. A user may use the external optical scanner 122 to scan the barcode 142 of the cassette 140 as a means for entering information into the hazardous contamination detection apparatus 100. Alternatively or additionally, the internal optical scanner of the hazardous contamination detection apparatus 100 may be positioned to scan the barcode 142 when the assay cartridge 140 is inserted into the assay cartridge receiving aperture 134 of the hazardous contamination detection apparatus 100. Such information contained in the bar code 142 may include cartridge-specific or assay-specific information, such as an assay test type identifier or one or more operating parameters for performing the test. In other embodiments, the barcode 142 may include additional information, such as test location identification information, a barcode password for unlocking the functionality of the hazardous contamination detection device 100, and the like.

The hazardous contamination detection device 100 may include one or more additional data communication ports (not shown), such as a USB port. The port may be provided as a generic hardware interface of the hazardous contamination detection apparatus 100. Using this interface, the hazardous contamination detection device 100 may support external peripheral devices, such as a printer or a keyboard. The port may enable the basic hazardous contamination detection device 100 to be connected to a PC for data download. For example, when the hazardous contamination detection apparatus 100 is connected to a PC via a USB interface, the reader apparatus may function like a USB drive. In addition, the end user may update the reader device firmware by connecting a USB drive containing the latest firmware revision to the USB port. Further, the USB port provides a convenient way to upload assay calibration data (e.g., lot-specific calibration data) into the reader device.

Referring now to fig. 1C and 1D, a user may obtain a liquid sample at a test location to determine whether a hazardous contaminant is present at the test location. For example, the surface 150 may be tested by using a swab 160 wetted with a buffer solution. In some embodiments, template 165 may be used to define a test area. After the liquid sample is wiped or otherwise obtained from the surface 150, the swab 160, or a portion thereof, may be placed into the sample container 155. The sample containers 155 may be pre-marked with location-specific machine-readable information labels, such as barcode labels 157 corresponding to individual test locations. Referring to fig. 1D, the user may then apply at least a portion of the liquid sample from the sample container 155 to one or more assay cartridges 140 that may be inserted into the hazardous contamination detection apparatus 100. It will be understood that various other sample collection techniques may be equally implemented by embodiments of the present disclosure.

Referring now to FIG. 2, an example medical facility 200 in which the disclosed hazardous contamination detection systems and methods may be implemented is schematically illustrated. As shown in FIG. 2, a medical facility 200 in which antineoplastic drugs or other hazardous contaminants may be used may include various locations in which contaminants may be stored, administered, transported, or otherwise used. For example, the medical facility 200 may include areas such as a nurse station 205, a pharmacy 210, a clean room 215, a reception room 220, a medical room 225, a disposal room 230, and/or one or more patient rooms 235. Within each area, it may be desirable to test multiple locations, such as tables, desks, workstations, ingredient enclosures (compounding hoods), chairs, beds, storage cabinets, drug inventory carts, counters, IV racks, floors, waste containers, and the like, for the presence of potentially hazardous contaminants. If manual recording is used to associate test locations with corresponding test results, a large number of possible test locations may allow for a high probability of error in the location markers. Furthermore, the time required to manually record the location of each test can be very time consuming. The systems and methods described herein may improve the efficiency and accuracy of location-specific hazardous contamination testing.

As will be described in greater detail below, in one example embodiment, a location-specific machine-readable information tag is located on each of a plurality of test locations and is scanned by an operator during a location-specific hazardous contamination test according to the present disclosure. In another example embodiment, the location-specific machine-readable information labels are pre-printed and stored at each of a plurality of testing locations, thereby allowing an operator to quickly and easily apply one of the pre-printed labels to a sample container for hazardous contamination testing when the operator reaches the testing location. In yet another example embodiment, the operator prints a location-specific machine-readable information label at each of the plurality of testing locations (or at another station), and applies the label to the sample container before initiating the location-specific hazardous contamination test.

FIG. 3 illustrates a schematic block diagram of one possible embodiment of the internal components of an example hazardous contamination detection apparatus 300. The hazardous contamination detection apparatus 300 may include one or more of the features of the hazardous contamination detection apparatus 100 described above.

The components may include a processor 310 linked to and in electronic communication with a memory 315, a working memory 355, a cartridge reader 335, an external scanner 345, a display 350, and a communication module 352.

The cassette reader 335 may include one or more photodetectors 340 for reading the sensing member held in the inserted cassette. The cassette reader 335 may send image data from the one or more photodetectors to the processor 310 for analysis of the image data representing the imaged assay to determine a test result for the assay. Photodetector(s) 340 may be any device suitable for generating an electrical signal representative of incident light, such as a PIN diode or PIN diode array, a Charge Coupled Device (CCD), or a Complementary Metal Oxide Semiconductor (CMOS) sensor, to name a few examples. The cartridge reader 335 may also include a means for detecting cartridge insertion, such as a mechanical button, an electromagnetic sensor, or other cartridge sensing device. The indication from this component may direct processor 310 to begin the automated assay reading process without any further input or instruction from the user of device 300. One example automatic assay reading process is the walk-off mode described above.

The external scanner 345 and the internal scanner 347 may additionally include one or more photodetectors. The external scanner 345 and the internal scanner 347 may also transmit image data representing the imaged cassette and/or the imaged location-specific machine-readable information label for use in determining which of a plurality of automated processes to implement for imaging the assay and/or determining a location identifier to store in association with the test results.

The processor 310 may be configured to perform various processing operations on image data received from the cartridge reader 335, the external scanner 345, and/or the internal scanner 347 in order to determine and store test result data, as will be described in more detail below. Processor 310 may be a general purpose processing unit that performs assay analysis functions or a processor specifically designed for assay imaging and analysis applications. For example, the processor 310 may be a microcontroller, microprocessor, or ASIC (to name a few examples) and may include multiple processors in some embodiments.

As shown, the processor 310 is connected to a memory 315 and a working memory 355. In the illustrated embodiment, memory 315 stores a location determination component 320, a test result determination component 325, a data communication component 330, and a test data repository 305. These modules include instructions that configure the processor 310 of the device 300 to perform various location tagging, image processing, and device management tasks. The processor 310 may use the working memory 355 to store a working set of processor instructions contained in the modules of the memory 315. Alternatively, the processor 310 may also use the working memory 355 to store dynamic data created during operation of the device 300.

As described above, the processor 310 may be configured by several modules stored in the memory 315. The location determining component 320 may include instructions to control the detection of the location identifier at the external scanner 345. For example, location determining component 320 may include instructions that invoke subroutines to configure processor 310 to perform functions such as directing a user to scan a location barcode, detect a location barcode scanned at external scanner 345, and determine a location identifier based at least in part on the location barcode. The test result determination component 325 may include instructions that invoke a subroutine to configure the processor 310 to analyze the assay image data received from the photodetector(s) 340 in order to determine the result of the assay. For example, the processor may compare the image data to a plurality of templates or pre-identified patterns to determine a test result. Other implementations are possible, as will be appreciated by those skilled in the art. In some embodiments, the test result determination component 325 may configure the processor 310 to perform an adaptive reading process on the image data from the photodetector(s) 340 to improve specificity of the detection results and reduce false positive results by compensating for background and non-specific binding.

Data communication component 330 may cause the test results and associated information (such as the location identifier determined by location determining component 320) to be stored locally in test data repository 305. If a local wired or wireless connection is established between the device 300 and another computing device, the data communication component 330 may prompt the user of the device 300 to scan the cryptographic barcode using an inserted module (e.g., the external scanning module 110 implemented in the hazardous contamination detection device 100 or the external scanner 345 implemented in the device 300) in order to access the data in the repository 305. In some embodiments, data communication component 330 may further cause communication module 352 to send data or receive data from another computing device.

The processor 310 may be configured to control the display 350 to display, for example, captured image data, imaged barcodes, test results, and user instructions. Display 350 may include a panel display, such as an LCD screen, LED screen, or other display technology, and may implement touch-sensitive technology.

Processor 310 may write data, such as data representing captured images of barcodes and sensing elements, instructions or information associated with the imaged barcodes, and determined test results, to data repository 305. Although data repository 305 is graphically represented as a conventional disk device, one skilled in the art will appreciate that data repository 305 may be configured as any storage media device. For example, data repository 305 may include a disk drive (such as a hard disk drive, an optical disk drive, or a magneto-optical disk drive) or solid state memory (such as flash memory, RAM, ROM, and/or EEPROM). The data repository 305 may also include a plurality of memory units, and any of the memory units may be configured within the hazardous contamination detection device 300, or may be external to the device 300. For example, the data repository 305 may include a ROM memory containing system program instructions stored within the assay reader device 300. Data repository 305 may also include a memory card or high speed memory removable from device 300 configured to store captured images.

Although fig. 3 depicts the device as having separate components to include the processor, the cartridge reader, the module interface, and the memory, those skilled in the art will recognize that these separate components may be combined in various ways to achieve specific design goals. For example, in alternative embodiments, memory components may be combined with processor components to save cost and improve performance.

Furthermore, while FIG. 3 shows many memory components, including a memory 315 containing several modules and a separate memory 355 containing working memory, those skilled in the art will recognize several embodiments utilizing different memory architectures. For example, a design may utilize ROM or static RAM memory to store processor instructions implementing the modules contained in memory 315. The processor instructions may be loaded into RAM to facilitate execution by the processor 310. For another example, working memory 355 may include RAM memory, where instructions are loaded into working memory 355 prior to execution by processor 310.

FIG. 4 is a flow chart depicting an example operational procedure 400 of a hazardous contamination detection apparatus as disclosed herein. In some embodiments, the process 400 may be implemented by the hazardous contamination detection apparatus 100 and/or the processor 310.

At block 405, the processor 310 receives a power-on indication, for example, in response to a user pressing a single button located on an assay reader device.

At block 410, the processor may detect insertion of an assay cartridge, e.g., insertion of the assay cartridge 140 into the assay cartridge receiving aperture 134.

At block 415, the hazardous contamination detection device 100 may request a location scan. For example, the processor 310 may cause the display 350 to display instructions that prompt the user to scan a location-specific machine-readable information label (such as a location barcode) at an external scanner 345 (e.g., the external optical scanner 122). The user may scan (e.g., attach) a location-specific machine-readable information label located at a particular location at which a test is to be performed (such as, but not limited to, the testing location indicated in fig. 2), or attach to a location-specific machine-readable information label of a sample container that will receive a collected sample.

It will be appreciated that block 415 may be implemented prior to 410.

At decision block 420, the processor 310 may determine whether a location scan is received. For example, the processor 310 may determine whether a barcode or other machine-readable information is imaged at the external scanner 345 and whether the imaged machine-readable information contains data formatted as a location identifier. If a location scan is not received (e.g., if no machine-readable information is imaged or the imaged machine-readable information does not contain a suitable location identifier), the method 400 may return to block 415 and the processor 310 may cause the display 350 to again display or continue to display user instructions requesting a location scan. If a location scan is received at decision block 420, the method 400 continues to block 425.

At block 425, the processor 310 may identify a location associated with the location scan. For example, the processor 310 may determine a location identifier that includes at least a portion of the machine-readable information. In some embodiments, the processor 310 may cause the determined location identifier or other location information to be stored in the working memory 355 and/or the memory 315.

At block 430, the processor 310 may optionally determine one or more items of additional information. For example, the processor 310 may cause the internal scanner 347 to scan a barcode or other machine-readable information located on an inserted assay cartridge. In various embodiments, the additional information contained within the barcode on the assay cartridge can include, for example, information related to the assay test, such as a test type identifier, a substance detectable by the assay, one or more operating parameters for performing the test, and the like.

At block 435, the processor 310 determines the test results. In one example, the test results are determined by imaging the probe and determining the test results based on image data representative of the probe. In some embodiments, the test results are determined based at least in part on the additional information determined at block 430. Block 435 may be implemented as any of the disclosed reader operating modes, such as an endpoint read mode or a walk-away mode, or any other suitable mode.

At block 440, the processor 310 stores the test results locally along with any associated data (e.g., the image of the test piece used to generate the test results and additional information provided via the scanned bar code). For example, the processor 310 stores the test results (e.g., positive or negative, and optionally, an identifier of the contaminant being tested) in association with the determined location information. In one example, processor 310 stores the test results locally by editing the CSV file stored in test data repository 305 to add one or more values identifying the test results and the test locations. Additionally or alternatively, the processor 310 may transmit the test results, and optionally any associated data, to the destination database or contact via a network. This may be accomplished, for example, through the communication module 352.

At block 445, the processor 310 may wait a predetermined period of time before powering down the assay reader device. Additionally or alternatively, the hazardous contamination detection apparatus 300 may be configured to be manually powered off.

FIG. 5 is a flow chart depicting an example process 500 for performing location-specific testing using a hazardous contamination detection apparatus as described herein. In some embodiments, the process 500 may be implemented at least in part by a user and/or the hazardous contamination detection device 100 and/or the processor 310.

At block 505, a test location is determined. The test locations may correspond to one or more locations described above with reference to fig. 2, e.g., a room within a facility and/or one or more surfaces, items, or areas within the room. At block 510, location-specific machine-readable information is generated for the determined test locations. In some embodiments, an alphanumeric location identifier may be assigned to correspond to each physical location. Examples of alphanumeric location identifiers are described in more detail with reference to fig. 8A-8C.

At block 510, location-specific machine-readable information is generated for each test location. In some embodiments, generating location-specific machine-readable information may include encoding the alphanumeric location identifier into a machine-readable format, such as a barcode, QR code, or the like. Additionally or alternatively, generating location-specific machine-readable information may include identifying existing items of machine-readable information to be used as location-specific machine-readable information for a location. For example, if the determined test location is on or near a piece of equipment that has a bar code or other machine-readable information item (e.g., an equipment identification code or other code) displayed thereon, then the existing information that has been displayed at that location may be used as location-specific machine-readable information rather than generating new location-specific machine-readable information for that location.

At block 515, the location-specific machine-readable information generated at block 510 is associated with a corresponding location. In some embodiments, the association at block 515 may be performed using the hazardous contamination detection device 300, for example in a location assignment mode, where location-specific machine-readable information items (e.g., barcodes) may be scanned at the external scanner 345 in order to associate the tag with a known alphanumeric location identifier.

At block 520, location-specific machine-readable information may be applied to the sample container while performing the hazardous contamination test. In some embodiments, individual location-specific machine-readable information items (e.g., barcodes) may be printed onto multiple labels (e.g., stickers, other adhesive markings, etc.). A plurality of labels (each containing a bar code or other machine-readable information corresponding to a particular location) may be stored at that location for subsequent application to a sample container for hazardous contamination testing at that particular location. In some embodiments, location-specific machine-readable information for multiple locations may additionally or alternatively be maintained in proximity to the hazardous contamination detection device 300, such as in a list, folder, book, instruction manual, or the like.

At block 525, a sample is collected from the test site. Various example test methods include providing a buffer solution to a surface and wiping the wetted surface with an absorbent swab, or wiping the surface with a swab pre-wetted with the buffer solution. The buffer fluid may have properties that aid in picking up contaminants from the surface. In some embodiments, the buffer fluid may have properties that aid in releasing the collected contaminants from the swab material. The collected contaminants can be mixed into a homogeneous solution for testing. The buffer solution, along with any collected contaminants, may be expressed or extracted from the swab to form a liquid sample. The liquid sample may be placed into a sample container that has been prepared by affixing a location-specific barcode label to the container, or a barcode label may be affixed to the container after the sample is obtained. In some embodiments, for example, if the sample is to be tested at a detection device located at or near the testing location, the collected sample may not be physically marked by the location-specific barcode label. At block 530, the sample is applied to the probe. For example, at least a portion of the liquid sample can be placed onto an assay 144 contained within the assay cartridge 140, as described with reference to fig. 1A and 1B.

At block 535, the prepared assay is tested at a reader device (such as the hazardous contamination detection device 100, 300 described with reference to fig. 1A and 3). In some embodiments, the testing includes powering on the reader device and inserting an assay cartridge containing the assay into the reader device. Upon detecting insertion of the assay cartridge, the reader device may display instructions for providing a position scan. In response to such instructions, a user implementing the method 500 may scan a bar code label at the external optical scanner 122 or the external scanner 345 that is affixed to a sample container holding a sample for preparation of the probe being tested. In another example, a user may scan a barcode or other machine-readable information item corresponding to a known location from which a sample was obtained. For example, a user may scan a location-specific machine-readable information label present at a testing location, such as from a label affixed to the testing location. The assay test protocol may then continue as described above with reference to fig. 4.

FIG. 6 illustrates example display text that may be presented to an operator of a hazardous contamination detection device, for example, at display 136 of device 100 or display 350 of device 300. As described above, embodiments of the systems and methods described herein may allow an end user to customize the type of information to be stored in conjunction with test results on a particular hazardous contamination detection device, thereby significantly improving compliance and traceability of test results and reducing transcription and documentation errors. In embodiments including wireless or cellular connectivity capabilities, a custom report including test results associated with a selected category of information may be automatically transmitted to a remote server. The top display in the first column of the example display in fig. 6 shows a display of a hazardous contamination detection device that prompts a user to scan a configuration barcode to enable or disable the association of specific types of information with test results. In this non-limiting example, after reading the "scan configuration barcode" prompt, the user scans a barcode instructing the hazardous contamination detection device to enable the operator ID function (if the user wishes to associate and store the operator ID information with the test results), or the user scans a barcode instructing the hazardous contamination detection device to disable the operator ID function (if the user does not wish to associate and store the operator ID information with the test results). In another example, a "scan configuration barcode" prompt may allow a user to scan a barcode that directs a hazardous contamination detection device to store location information and test results. In another example, the "scan configuration barcode" prompt may allow a user to scan a barcode that causes the hazardous contamination detection device to enter a location information distribution mode, as described above with reference to block 510. After the user scans the barcode indicating the user's selection, the hazardous contamination detection device displays text confirming the user's selection. In this non-limiting example, the hazardous contamination detection device displays "operator ID scan enabled" or "operator ID scan disabled" to the user. Similarly, if the configuration barcode directs the hazardous contamination detection device to enable location ID functionality, the hazardous contamination detection device may display "location ID scan enabled" or "location ID scan disabled" to the user. The hazardous contamination detection equipment may then require the user to enable or disable other types of information functions, such as, but not limited to, location ID, sample ID, and kit lot ID (see, e.g., the example display test in fig. 6).

With the location ID function enabled, the hazardous contamination detection device will now prompt the user to scan the barcode associated with the location ID of each test event. For example, prior to prompting the user to enter an assay test strip into the device for analysis, the hazardous contamination detection device will display a "scan location ID" to the user, thereby instructing the user to scan a barcode associated with the location ID of the location from which the sample was obtained. As described above, the barcode may be located on the sample container holding the sample to be tested, or it may be located at the test site where the sample is collected. The hazardous contamination detection device may sequentially query the user to enter specific types of information according to previously selected, customized configuration settings of the hazardous contamination detection device. For example, after the user scans the barcode associated with the location ID, if the device is configured to request sample ID or operator ID information, the hazardous contamination detection device may next prompt the user to scan the barcode associated with the sample ID of the test event (e.g., see the "scan sample ID" display in fig. 6) or the operator ID (e.g., see the "scan operator ID" display in fig. 6). In some cases, the hazardous contamination detection device will not prompt the user to enter the assay test strip for analysis until all the information needed for a particular configuration setting has been entered. In some cases, the hazardous contamination detection device may display an overview of the configuration settings (see, e.g., the example display at the top of the middle column in fig. 6).

Referring now to fig. 7A-7D, various example workflows may be implemented by the systems and methods described herein to effectively implement hazardous contamination testing at multiple locations within a facility. Each of the workflows depicted in fig. 7A-7D is illustrated with reference to the example medical facility 200 shown in fig. 2. However, it will be understood that the workflows of fig. 7A-7D are examples, and that the systems and methods according to the present disclosure may be implemented in any facility in which hazardous contamination testing is to be performed. Each of the workflows of fig. 7A-7D provides a process for testing one or more hazardous contaminants at a plurality of test locations 710 using one or more hazardous contamination detection devices stored at detector location 705. For example, the hazardous contamination detection apparatus 100 or the hazardous contamination detection apparatus 300 may be stored and used by an operator at the detector location 705 after the operator has collected a sample at the test location 110. As will be described below, it will be understood that a facility may have multiple test devices each stored at one of multiple detector locations 705. It will also be understood that any workflow or combination of workflows of fig. 7A-7D may be selected and implemented at individual facilities based on, for example, the number of rooms to be tested, the number of available hazardous contamination detection equipment, the size of the facility, and the like.

Fig. 7A schematically illustrates a first example workflow in which a single hazardous contamination detection device is located at detector location 705. In the non-limiting example workflow of FIG. 7A, the location barcode label is stored at or near the test location 710. For example, each test location 710 or the room containing the test location 710 may include one or more location-specific label dispensers. The location-specific label dispenser may be a printer configured to print location-specific labels; a book, folder or sheet having stored therein a plurality of preprinted copied location-specific labels; or any other suitable dispenser. In one non-limiting example, adhesive indicia displaying corresponding location-specific machine-readable information is provided in a book, folder, or sheet stored at test location 710. Thus, a user, such as a test operator, may obtain a plurality of empty sample containers (e.g., from a central storage location near the detector location 705) and travel to various test locations 710 within the facility. At each test location 710 where the user will perform a hazardous contamination test, the user selects the appropriate location label and applies the location label to the individual sample container. After performing the test at each location, the user places the obtained sample into a labeled sample container and proceeds to the next location. After all desired locations have been tested, or after the user's sample containers have all been used to collect samples, the user may return to the detector location 705. At detector location 705, the user tests each obtained sample in sequence, for example, by powering on a hazardous contamination detection device; scanning a location specific bar code affixed to a first sample container holding a sample to be tested when prompted; applying an individual liquid sample from a first sample container to a test element in a first test cartridge; inserting a first assay cartridge having a sample applied thereto into a hazardous contamination detection apparatus; repeating the process with a second sample container and a second assay cartridge; and continuing the process until all collected samples have been tested. The other workflows may be implemented as described above with reference to fig. 4 and 5, or as any other suitable workflows. The location label affixed to each sample container allows the user to reliably scan the correct location label corresponding to the location where the sample was obtained without requiring the user to remember where to obtain individual samples, and while still allowing the user to collect a large number of samples during a single trip around the facility, rather than having to return to the detector location 705 after each sample is obtained.

Fig. 7B schematically illustrates a second example workflow. Similar to the first example workflow of fig. 7A, the workflow of fig. 7B utilizes a single hazardous contamination detection device at detector location 705. In the workflow of fig. 7B, a supply of pre-printed position labels need not be maintained at each test position 710. Instead, a position label is prepared and applied to the sample container at detector position 705 before a series of samples is collected. Subsequently, upon reaching each test location 710, the user identifies a pre-labeled sample container corresponding to the test location 710 and places the sample obtained at the test location 710 into the identified sample container before returning to the detector location 705 to perform testing of the collected sample.

Fig. 7C schematically illustrates a third example workflow. Similar to the workflow of fig. 7A and 7B, the workflow of fig. 7C may still be implemented by a single hazardous contamination detection device. However, in the third example workflow of fig. 7C, the hazardous contamination detection device travels with the user as the user collects the sample at the test location 710. At each test location 710 or within each room, a user may collect one or more liquid samples and may apply the liquid samples to the test piece and test the test piece at the test location 710. In some embodiments, the third example workflow of fig. 7C may be implemented without individually labeling the sample containers with position labels. For example, each test location 710 may have a single location-specific machine-readable information label affixed thereto, such that when the hazardous contamination detection device displays instructions to provide a location scan, a user may scan the label at the test location 710, rather than the label on the sample container. Examples of test locations 710 that may have a single location-specific machine-readable information label affixed thereto include, but are not limited to, ingredient hoods, IV racks, drug inventory carts, and hazardous or non-hazardous waste containers in a disposal room.

Fig. 7D schematically illustrates a fourth example workflow. The fourth example workflow may be implemented in a facility that includes a plurality of hazardous contamination detection equipment located at a plurality of detector locations 705. Thus, each hazardous contamination detection apparatus may be used to test a sample obtained at a test location 710 near the individual hazardous contamination detection apparatus. In some embodiments, the fourth example workflow of FIG. 7D may further reduce the probability of user error by reducing the number of test locations 710 to be tested at each hazardous contamination detection device. The fourth example workflow may be implemented using location barcode labels that are individually affixed to sample containers when samples are collected at the testing location 710, and/or may be implemented by pre-labeling each sample container before traveling to the testing location 710 (e.g., as described with reference to fig. 7A or 7B).

Fig. 7E-7G illustrate example configurations for providing location-specific machine-readable information tags as described above with reference to fig. 7A-7D. Although the machine-readable information label is depicted as a bar code label in fig. 7E-7G, it will be understood that any other type of machine-readable information may be used. Fig. 7E and 7F show embodiments in which an individual test location 710 has a location-specific barcode label 715 affixed at or near that location. For example, in fig. 7E, test position 710 is an IV rack. The barcode label 715 is affixed to the IV rack so that a user performing a hazardous contamination test according to the workflow of fig. 7C can obtain a sample, apply the sample to the assay, insert the assay into the detection device, and scan the barcode label 710 on the IV rack by the detection device when prompted to provide a location scan. Similarly, in fig. 7F, test location 710 is a portion of a floor. In this example, the barcode label 715 is located near the testing location 710 but not directly on the testing location 710, e.g., affixed to the base of a piece of equipment held in the room in which the testing location 710 is located.

Fig. 7G shows an example configuration in which multiple barcode labels 715 are provided for use on individual sample containers 725. The plurality of barcode labels 715 may be provided, for example, as a sheet 720 of barcode labels 715 printed on adhesive markings or the like. Thus, a user performing a hazardous contamination test according to any of the workflows of fig. 7A-7D may travel to a testing location 710, remove a single bar code label 715 from a sheet 720 or other container of bar code labels 715, obtain a sample container 725 for testing the testing location 710, and affix the bar code labels 715 to the sample container 725, such that when a sample is obtained from the testing location 710, the sample may be placed directly into the container pre-labeled with the correct testing location 710, thereby avoiding erroneous location information due to, for example, user error. Fig. 7H illustrates an example sheet 720 of barcode labels 715 as described with reference to fig. 7G.

Fig. 8A-8C illustrate example reports that may be generated according to the location-specific hazardous contamination detection systems and methods described herein. As described herein, the customizable reporting functions may be processed on the server side or by one or more remote computing devices that are physically separate from the hazardous contamination detection device, but receive information from the hazardous contamination detection device. For example, test result data and associated information (e.g., location identifiers) from the scanned bar code may be stored in a database of one or more remote computing devices (e.g., server systems), and the remote computing devices may generate custom reports having only fields of interest to the end user. End users may include, but are not limited to, users of the reader devices, administrators in healthcare facilities using the reader devices, entities managing remote server systems, and public health organizations.

The data stored in the hazardous contamination detection device may be obtained via a wired connection (such as through a USB port or other data connection of the device) and/or a wireless connection (such as by export via Wi-Fi, cellular data transmission, etc.), for example, as described at communications module 352 with reference to fig. 3. In some embodiments, the transfer of data, such as a CSV file or other data format, may be accomplished by providing security credentials, such as by scanning an unlock barcode or other code at the device to unlock and/or initiate the data transfer. In some embodiments, the security credentials may temporarily unlock USB or wireless access to a memory of the device (such as memory 352 and/or working memory 355 described with reference to fig. 3) for a predetermined unlock period and/or until the next power down of the device. The communicated data may then be analyzed using one or more analysis software packages. For example, a suitable analysis software package may be configured to receive data in a preselected format consistent with the format output by the hazardous contamination detection equipment. In some embodiments, the analysis software package may include one or more templates that may be used and/or executable, at least in part, in connection with one or more commercially available software packages, such as spreadsheet software (e.g., Excel, etc.). It will also be appreciated that the analysis and reporting of data may be performed based on data from a single hazardous contamination detection device and/or based on a pool of data obtained from multiple hazardous contamination detection devices located within a single facility and/or distributed across multiple facilities associated with end users or other entities.

The example report of FIG. 8A illustrates several example analyses that may be automatically performed based on data stored at the hazardous contamination detection equipment from multiple tests. A first window 805 of the example report displays a record of the individual tests performed at the device. For each row corresponding to an individual test, a first window displays the date and time at which the test was performed (e.g., a timestamp recorded by the device based on the time indicated by the device's internal clock when the assay cartridge was inserted into the device or a timestamp adjusted based on the analyzer time correction factor); a location identifier indicating a location at which the test sample was obtained (e.g., a location identifier such as "InPt-PtRoom 7-Counter" may correspond to a table within the patient room7, a location identifier such as "InPt-PtRoom 3-IV Pole" may correspond to a surface of an IV rack within the patient room3, etc.); test name (e.g., an identifier of the substance tested in each test, e.g., an anti-tumor agent such as methotrexate or doxorubicin, etc.); test results (e.g., positive or negative for the presence of a substance); and/or any other relevant information corresponding to each test. A first window 805 may allow an end user to view individual test records. In some embodiments, the individual records may be modified within the analysis software package, but may be write-protected on the hazardous contamination detection device (e.g., within a write-protected CSV file) so that the original test records stored within the device are not affected by any changes made in the subsequent analysis of the test data.

As shown in the second window 810, the individual test results may be aggregated and grouped by one or more criteria, such as by test name. In the example report of fig. 8A, the test name for each individual test is the name of the drug corresponding to doxorubicin or methotrexate. In a second window 810, a bar graph shows the number of positive and negative test results for each drug. Such a comparison may allow the end user to effectively assess the frequency with which each tested drug spills, leaks, or is otherwise allowed to contaminate surfaces in the facility. For example, if a particular drug is associated with an increased frequency of positive tests as compared to other drugs used in the facility, it may be determined that aspects of the packaging, storage, handling, administration, or disposal of the particular drug should be modified to reduce the frequency of contamination.

As shown in the third window 815 and the fourth window 820, the individual results of the aggregation may also be grouped by location-specific criteria. For example, window 815 is a bar graph showing the relative number of positive and negative results for each location of methotrexate ("MTX"), and window 820 is a bar graph showing the relative number of positive and negative results for each location of doxorubicin ("DOX"). In some embodiments, a location-specific report may be generated for a combination of multiple test names (e.g., a location-specific report for a combined methotrexate and doxorubicin test). Comparing positive and negative test results by location may allow an end user to effectively assess the frequency of contamination occurring at individual locations. For example, if a small subset of locations within a facility are associated with elevated frequencies of positive tests as compared to other locations within the facility, the end user may be better able to identify and mitigate any cause of such elevated frequencies. Example reasons for a location-specific high contamination frequency may include the type and location of hazardous drug storage in the location, the individual person handling the hazardous drug at the particular location, or other factors. This information may help to ascertain that the cause of the elevated contamination event is an operator error or untrained operator, rather than a product defect in, for example, a hazardous drug storage or dispensing system.

In addition to the specific analysis depicted in fig. 8A, it will also be understood that various additional methods of analysis may also be possible with the systems and methods described herein. For example, data obtained at one or more hazardous contamination detection devices may enable analysis of trends in positive results by time, by day of the week, by time of day, by time of year, by operator, by location (e.g., for an individual contaminant or multiple contaminants), by contaminant, by department or sub-department, by ratio of positive results to negative results by location, or generally by frequency of testing of variables, and the like. The systems and methods herein may further provide for analysis of error code results, retest identification and result linking, variation in results of samples collected before and after surface cleaning, and post-leak testing.

FIG. 8B shows an example report in which data is aggregated yearly. As shown in fig. 8B, data obtained from one or more hazardous contamination detection devices during a specified time period (e.g., a calendar year such as 2018, a fiscal year, a month, a plurality of years, or other time period) may be analyzed to identify various trends in the data. The exemplary report of fig. 8B is based on data on positive and negative results with respect to time stamping and location labeling of tests performed to detect three hazardous contaminants (e.g., the antineoplastic drugs cyclophosphamide, doxorubicin, and methotrexate). Thus, data collected using the systems and methods described herein can prepare reports (such as the report of fig. 8B) that allow the end user to see useful data trends, such as total positive results by month, total positive results by individual contaminant, positive results by month and by individual contaminant, and the relationship of positive results to negative results subdivided by individual location for each individual drug.

FIG. 8C illustrates an example "current report" in which the hazardous contamination test results are aggregated to provide a latest report on the current trend of hazardous contamination at the facility. Similar to the report of fig. 8B, the report of fig. 8C depicts positive and negative test results for cyclophosphamide, doxorubicin, and methotrexate polymerization. The first column of the report of fig. 8C depicts the most recent results (e.g., positive and/or negative for the most recent test(s) performed at each test location). The second column depicts the total positive and negative results within a previous period (e.g., the last 6 months, or any other desired period of time at the end of the current time) at the end of the current time. The third column describes the total positive and negative results for each contaminant tested, for example, over the same 6 month period or any other desired time period.

It will be understood that any of the analysis and/or information display formats depicted within the reports of fig. 8A-8C may be included in the reports generated based on the data obtained by the hazardous contaminant detection systems and methods described herein, in combination and/or with any other suitable information display format.

The system described herein may also be configured to provide an automatic alert to one or more end users based on the analyzed test data. For example, alerts may be provided to one or more end users when a planned test expires at a particular test location, or for planned events, such as retest alerts, planned test alerts, assay expiration alerts, repeat alerts, and the like. Thus, the systems and methods described herein may additionally be used to monitor compliance with an expected test schedule.

In some embodiments, the described systems and methods can collect, detect, and track minute amounts of anti-tumor agents and/or chemotherapeutic drugs. It will be appreciated that in other embodiments, the described system may be adapted to collect and detect the amount of other bio-hazardous chemicals, drugs, pathogens, or substances. In addition, the disclosed system may be used in forensic, industrial, and other settings.

Implementation System and terminology

Embodiments disclosed herein provide systems, methods, and apparatus for a modular, reconfigurable assay reader. Those skilled in the art will recognize that these embodiments may be implemented in hardware or a combination of hardware and software and/or firmware.

The assay reader device may include one or more image sensors, one or more image signal processors, and memory including instructions or modules for performing the processes discussed above. The device may also have a processor to load data, instructions and/or data from memory, one or more communication interfaces, one or more input devices, one or more output devices (such as a display device), and a power supply/interface. The device may also include a transmitter and a receiver. The transmitter and receiver may be collectively referred to as a transceiver. The transceiver may be coupled to one or more antennas for transmitting and/or receiving wireless signals.

The functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that is accessible by a computer or processor. By way of example, and not limitation, such media can comprise RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk and disc, as used herein, includes Compact Disc (CD), laser disc, optical disc, Digital Versatile Disc (DVD), floppy disk anddisks, where the disk usually reproduces data magnetically, and the disk optically reproduces data by a laser. It should be noted that computer-readable media may be tangible and non-transitory. The term "computer program product" refers to a computing device or processor in combination with code or instructions (e.g., a "program") that may be executed, processed, or computed by the computing device or processor. As used herein, the term "code" may refer to software, instructions, code or data that is executable by a computing device or processor.

The various illustrative logical blocks and modules described in connection with the embodiments disclosed herein may be implemented or performed with a machine such as a general purpose processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be a controller, microcontroller, or state machine, combinations of these, or the like. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, the processor may also primarily include analog components. For example, any of the signal processing algorithms described herein may be implemented in analog circuitry. The computing environment may include any type of computer system, including, but not limited to, computer systems based on microprocessors, mainframe computers, digital signal processors, portable computing devices, personal organizers, device controllers, and computing engines within appliances, to name a few examples.

The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for proper operation of the described method, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.

It should be noted that, as used herein, the terms "coupled," "coupling," or other variations of the word "coupled" may indicate an indirect connection or a direct connection. For example, if a first element is "coupled" to a second element, the first element can be indirectly connected to the second element or directly connected to the second element. As used herein, the term "plurality" means two or more. For example, a plurality of components indicates two or more components.

The term "determining" encompasses a variety of actions and, thus, "determining" can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Also, "determining" may include resolving, selecting, choosing, establishing, and the like. The phrase "based on" does not mean "based only on," unless expressly specified otherwise. In other words, the phrase "based on" describes that "is based only on" and "is based at least on" both.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.