阅读说明：本技术 一种用于胎膜早破精准检测的护垫 (A protection pad for premature rupture of membrane accurate detection ) 是由 田卫群 游国华 张天蔚 王适群 周颖 乐鑫 刘鸣 叶锐 于 2020-06-30 设计创作，主要内容包括：本发明公开了一种用于胎膜早破精准检测的护垫,涉及孕产检测领域,该护垫包括自上而下依次设置的表面层、吸水层和渗透隔离层；吸水层上设置有检测试纸条,检测试纸条用于检测AFP,检测试纸条包括底板,底板上顺次设置有样品垫、结合垫、NC膜和吸水垫,NC膜的一侧与结合垫相接触,另一侧与吸水垫相接触,NC膜上自结合垫向吸水垫方向依次设置有第一检测线、第二检测线和质控线,第一检测线、第二检测线上涂覆有不同的检测试剂,检测试剂为AFP检测试剂、β-hCG检测试剂或IGFBP-1检测试剂,质控线上设置有羊抗鼠二抗检测试剂。本发明能够快速区分羊水和尿液,并准确判断是否出现羊水渗漏的情况,同时,便于及时发现和取样。(The invention discloses a protection pad for accurately detecting premature rupture of a fetal membrane, and relates to the field of pregnancy detection, wherein the protection pad comprises a surface layer, a water absorption layer and a permeation isolation layer which are sequentially arranged from top to bottom; be provided with the test paper strip on the layer that absorbs water, the test paper strip is used for detecting AFP, the test paper strip includes the bottom plate, be provided with the sample pad on the bottom plate in order, the combination pad, NC membrane and the pad that absorbs water, one side and the combination pad of NC membrane contact, the opposite side contacts with the pad that absorbs water, the NC membrane is gone up and is had set gradually first detection line to the pad direction that absorbs water from the combination pad, second detection line and quality control line, first detection line, the coating has different detect reagent on the second detection line, detect reagent is AFP detect reagent, beta-hCG detect reagent or IGFBP-1 detect reagent, be provided with the two detect reagent of goat anti mouse on the quality control line. The invention can rapidly distinguish the amniotic fluid from the urine, accurately judge whether the condition of amniotic fluid leakage occurs or not, and simultaneously facilitate timely discovery and sampling.)

1. The utility model provides a protection pad for broken accurate detection of fetal membrane is early, includes superficial layer (1), absorbs water layer (2) and infiltration isolation layer (3), its characterized in that: the water absorption layer (2) is positioned below the surface layer (1), and the permeation isolation layer (3) is positioned below the water absorption layer (2);

a detection test strip (4) is arranged on the water absorption layer (2), the detection test strip (4) is used for detecting AFP, the detection test strip (4) comprises a bottom plate (5), a sample pad (6), a combination pad (7), an NC membrane (8) and a water absorption pad (9) are sequentially arranged on the bottom plate (5), one side of the NC membrane (8) is contacted with the combination pad (7), the other side is contacted with the water absorption pad (9), a first detection line (10), a second detection line (11) and a quality control line (12) are sequentially arranged on the NC membrane (8) from the combination pad (7) to the water absorption pad (9), the first detection line (10) and the second detection line (11) are coated with different detection reagents, the detection reagent is an AFP detection reagent, a beta-hCG detection reagent or an IGFBP-1 detection reagent, and a goat anti-mouse secondary antibody detection reagent is arranged on the quality control line (12).

2. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the beta-hCG detection reagent comprises a nano-gold labeled mouse anti-beta-hCG monoclonal antibody and an unlabeled mouse anti-beta-hCG monoclonal antibody.

3. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the AFP detection reagent comprises a nano-gold labeled mouse anti-AFP monoclonal antibody and an unlabeled mouse anti-AFP monoclonal antibody.

4. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the IGFBP-1 detection reagent comprises a nano-gold labeled mouse anti-IGFBP-1 monoclonal antibody and an unlabeled mouse anti-IGFBP-1 monoclonal antibody.

5. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: and a breathable basement membrane (13) is arranged at the bottom of the permeation isolation layer (3).

6. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: and the bottom plate (5), the combination pad (7), the NC membrane (8) and the water absorption pad (9) on the detection test strip (4) are coated with waterproof materials.

7. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the detection test strip (4) is positioned on the top surface of the water absorption layer (2).

8. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the permeation isolation layer (3) is made of a medical microporous filtering membrane.

9. A pad for accurate detection of premature rupture of membranes according to claim 1, wherein: the bottom surface of the water absorption layer (2) is provided with a leakage-proof film or release paper.

10. A disposable pants with the accurate detection pad for premature rupture of membranes as claimed in any one of claims 1 to 9, characterized in that: the disposable underpants are provided with a protection pad for detecting premature rupture of the fetal membranes.

Technical Field

The invention relates to the field of pregnancy detection, in particular to a protection pad for accurately detecting premature rupture of membranes.

Background

During natural delivery of most pregnant and lying-in women, the fetal membranes can be naturally ruptured after the opening of the uterine orifice is larger than 3-4 cm, but some pregnant women rupture the fetal membranes after the number of pregnancy weeks is less than 37 weeks or before the pregnant women enter the labor process, so that amniotic fluid flows out of the vagina, and the condition is called 'early water breaking' or 'premature rupture of the fetal membranes'.

Premature rupture of the fetal membrane can lead to the increase of the premature birth rate, the fatality rate of the perinatal infants is increased, the intrauterine infection rate and the puerperium infection rate are increased, and great harm is brought to the health of the lying-in women and the perinatal infants, so that the premature rupture condition of the fetal membrane is found in time and corresponding measures are taken, the risk of premature birth can be effectively reduced, and the health of the lying-in women and the perinatal infants is ensured.

At present, pH test paper protective pads and vaginal fluid smear microscopy are mainly adopted for detection, the false positive rate of the pH test paper protective pads is high, the vaginal fluid smear microscopy is complex in operation, and is influenced by the judgment difference of a detector, the situation of high false negative or false positive exists, and the accuracy rate is low.

Wearable amniotic fluid detection pads have appeared on the market, and a plurality of patents have been applied for protection: CN206044839U, CN105277656A, CN203089311U, CN204636718U, CN201752403U, CN104297241A, CN101813702B and CN204154653U, which mainly comprise sanitary pads, permeable layers and pH test paper, and the main principle of detection is that the pH value of vaginal fluid is 4.5-5.5 under normal conditions, and the pH value of amniotic fluid is 7-7.5, so that whether the amniotic fluid breaks early can be judged by detecting the pH value of the vaginal fluid, and an acid-base indicator is used for developing color to judge whether the amniotic fluid is.

However, urine of healthy people is weakly alkaline and slightly acidic, and the pH value ranges from 4.8 to 7.4; the vaginal secretion is acidic, the pH value is 3.8-4.5, and the pH value may reach 6.5 during infection; the amniotic fluid is neutral and slightly alkaline, and the pH range is 7.0-7.5; the pH value ranges of urine and amniotic fluid are in a cross overlapping region, whether the liquid is the amniotic fluid or not is detected by a single pH detection reagent of the sanitary pad close to the vaginal orifice and the urethral orifice, and the interference of the urine is obviously difficult to eliminate.

In order to improve the accuracy, the pH value is detected and the biochemical markers in the vaginal fluid are detected: diamine oxidase, prolactin, fetal fibronectin and the like, the method has high accuracy, but the amniotic fluid sample is detected in a laboratory by means of a highly sensitive instrument, and meanwhile, the pregnant woman has the defect that the number of times of urination is increased and stress urinary incontinence is easy to occur because the uterus of the pregnant woman is greatly pressed on the bladder in the late pregnancy period, the pregnant woman is difficult to judge whether the vaginal effluent is amniotic fluid or urine, and the amniotic fluid leakage caused by premature rupture of the fetal membranes is usually unconscious and cannot be controlled autonomously, so that a doctor is difficult to sample in time for detection, and diagnosis leakage is easy to cause.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a protection pad for detecting premature rupture of a fetal membrane, which can quickly distinguish amniotic fluid from urine, accurately judge whether the condition of amniotic fluid leakage occurs and facilitate timely discovery and sampling.

In order to achieve the above purposes, the technical scheme adopted by the invention is as follows:

a protection pad for detecting premature rupture of a fetal membrane comprises a surface layer, a water absorption layer and a permeation isolation layer, wherein the water absorption layer is positioned below the surface layer, and the permeation isolation layer is positioned below the water absorption layer;

the detection test strip is arranged on the water absorption layer and used for detecting AFP, the detection test strip comprises a bottom plate, a sample pad, a combination pad, an NC membrane and a water absorption pad are sequentially arranged on the bottom plate, one side of the NC membrane is in contact with the combination pad, the other side of the NC membrane is in contact with the water absorption pad, a first detection line, a second detection line and a quality control line are sequentially arranged on the NC membrane from the combination pad to the direction of the water absorption pad, different detection reagents are coated on the first detection line and the second detection line, the detection reagents are AFP detection reagents, beta-hCG detection reagents or IGFBP-1 detection reagents, and goat anti-mouse secondary antibody detection reagents are arranged on the quality control line.

Furthermore, the beta-hCG detection reagent comprises a nano-gold labeled mouse anti-beta-hCG monoclonal antibody and an unlabeled mouse anti-beta-hCG monoclonal antibody.

Further, the AFP detection reagent comprises a nano-gold labeled mouse anti-AFP monoclonal antibody and an unlabeled mouse anti-AFP monoclonal antibody.

Furthermore, the IGFBP-1 detection reagent comprises a nanogold-labeled mouse anti-IGFBP-1 monoclonal antibody and an unlabeled mouse anti-IGFBP-1 monoclonal antibody.

Further, the bottom of the permeation isolation layer is provided with a breathable basement membrane.

Furthermore, the bottom plate, the combination pad, the NC membrane and the water absorption pad on the detection test strip are coated with waterproof materials.

Furthermore, the detection test strip is positioned on the top surface of the water absorption layer.

Furthermore, the permeation isolation layer is made of a medical microporous filtering membrane.

Furthermore, the bottom surface of the water absorption layer is provided with a leakage-proof film or release paper.

A disposable pants with a pad for detecting premature rupture of membranes is provided with a pad for accurately detecting the premature rupture of membranes.

Compared with the prior art, the invention has the advantages that:

(1) the invention relates to a protective pad for accurately detecting premature rupture of membranes, which detects whether vaginal fluid contains amniotic fluid or not by using AFP, HCG and IGFBP-1 as markers to judge the premature rupture of membranes, high specificity, can effectively eliminate the interference of urine and other liquids on the detection, improves the accuracy of amniotic fluid detection, thereby reducing the probability of false positive detection, and simultaneously, because the pad is convenient to use and observe, additional sampling and inspection on a detector are not needed, compared with the prior art that the amniotic fluid leakage caused by premature rupture of the fetal membranes is usually unconscious and can not be controlled autonomously, so that doctors are difficult to sample in time for detection, the invention has strong effectiveness, can observe in time, effectively reduces the psychological panic of pregnant women, and timely treatment is carried out when the amniotic fluid leaks, the risk of premature delivery can be effectively reduced, and the health of the lying-in woman and the baby girls is ensured.

Drawings

FIG. 1 is a schematic structural diagram of a pad for precise detection of premature rupture of membranes according to an embodiment of the present invention;

FIG. 2 is a top view of FIG. 1;

FIG. 3 is a schematic structural diagram of the test strip.

In the figure: 1-surface layer, 2-water absorption layer, 3-permeation isolation layer, 4-test paper strip, 5-bottom plate, 6-sample pad, 7-combination pad, 8-NC membrane, 9-water absorption pad, 10-first detection line, 11-second detection line, 12-quality control line, 13-breathable bottom membrane and 14-sampling mark non-woven fabric.

Detailed Description

Embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

The detection principle of the invention is as follows: AFP is a fetal serum protein synthesized by fetal liver and yolk sac, during the whole gestation period, the amniotic fluid contains AFP, the peak is reached at 13-14 weeks of gestation, then the peak is reduced and maintained until delivery, and because AFP does not exist in vaginal secretion of normal pregnant women, AFP does not exist in the vaginal secretion only after amniotic fluid flows into vagina after the fetal membrane is broken, so that AFP can be used as an important marker for premature rupture of the fetal membrane.

IGFBP-1 (insulin-like growth factor binding protein-1) is a protein with the molecular weight of 25kDa, is synthesized and secreted by fetal or human liver cells and maternal decidua in a human body, after pregnancy, the concentration of IGFBP-1 begins to rise, and is one of the most main proteins in amniotic fluid from the middle of pregnancy to before delivery, IGFBP-1 in the amniotic fluid can flow into cervicovaginal through a breach when the fetal membrane is ruptured, while the concentration of IGFBP-1 in the amniotic fluid is 100-1000 times higher than that in urine and blood, even a small amount of side leakage can be detected, so that whether premature rupture of the fetal membrane occurs can be effectively judged by detecting leakage of IGFBP-1.

In addition, protein hCG synthesized by trophoblast cells of the pregnant woman is highly expressed in amniotic fluid in the whole gestation period, the content of hCG in vaginal secretion of a normal pregnant woman is low, and the content of hCG in the vaginal secretion is increased rapidly after amniotic fluid is ruptured by a fetal membrane and flows into the vagina, so that hCG in the vaginal secretion can also be used as a sensitive protein marker for premature rupture of the fetal membrane, and meanwhile, due to the fact that the content of HCG in urine is high, the pregnant woman in the late pregnancy period is easy to leak urine, the accuracy of detection results can be improved by jointly detecting and judging HCG, AFP and IGFBP-1.

Referring to fig. 1, an embodiment of the present invention provides a pad for accurately detecting premature rupture of a membrane, including a surface layer 1, a water-absorbing layer 2 and a permeable isolation layer 3, wherein a breathable bottom membrane 13 is disposed at the bottom of the permeable isolation layer 3, the water-absorbing layer 2 is disposed below the surface layer 1, the permeable isolation layer 3 is disposed below the water-absorbing layer 2, the surface layer 1 is made of non-woven fabric, the permeable isolation layer 3 is made of a medical microporous filtering membrane, and a leakage-proof membrane or release paper is disposed on the bottom surface of the water-absorbing layer 2.

Referring to fig. 2 and 3, the water absorption layer 2 includes a blue sampling mark non-woven fabric 14, a detection test strip 4 and a pure cotton spunlace non-woven fabric, which are sequentially arranged from top to bottom, and the blue sampling mark non-woven fabric 14 covers a portion of the detection test strip 4 containing a reagent, so as to prevent the reagent on the detection test strip 4 from irritating skin.

Referring to fig. 2, the test strip 4 comprises a bottom plate 5, a sample pad 6, a combination pad 7, an NC membrane 8 (nitrocellulose membrane) and a water absorption pad 9 are sequentially arranged on the bottom plate 5 from left to right, a part of one side of the sample pad 6, which is in contact with the combination pad 7, is in pressure joint with the combination pad 7, so that a sample can quickly spread onto the NC membrane 8 through the combination pad 7 after flowing to the sample pad 6, wherein the bottom plate 5, the combination pad 7, the NC membrane 8 and the water absorption pad 9 are all coated with waterproof materials, and only the sample pad 6 can absorb liquid (for absorbing vaginal fluid).

One side of the NC membrane 8 is in contact with the combination pad 7, the other side of the NC membrane 8 is in contact with the water absorption pad 9, a first detection line 10, a second detection line 11 and a quality control line 12 are sequentially arranged on the NC membrane 8 from the combination pad 7 to the water absorption pad 9, different detection reagents are coated on the first detection line 10 and the second detection line 11, the detection reagents are AFP detection reagents, beta-hCG detection reagents or IGFBP-1 detection reagents, and goat anti-mouse secondary antibody detection reagents are arranged on the quality control line 12.

The beta-hCG detection reagent comprises a nano-gold labeled mouse anti-beta-hCG monoclonal antibody and an unlabeled mouse anti-beta-hCG monoclonal antibody, and the beta-hCG detection reagent is coated on the NC membrane 8 to form a first detection line 10 or a second detection line 11; the AFP detection reagent comprises a nanogold-labeled rat anti-AFP monoclonal antibody and an unlabeled rat anti-AFP monoclonal antibody, and is coated on the NC membrane 8 to form a first detection line 10 or a second detection line 11; the IGFBP-1 detection reagent comprises a nanogold-labeled mouse anti-IGFBP-1 monoclonal antibody and an unlabeled mouse anti-IGFBP-1 monoclonal antibody, and the IGFBP-1 detection reagent is coated on the NC membrane 8 to form a first detection line 10 or a second detection line 11; the goat anti-mouse secondary antibody detection reagent is coated on the NC membrane 8 to form a quality control line 12.

In practical production, the size of the pad is set as required, in this embodiment, the total length of the pad is 15cm, the width of the test strip 4 is 1cm, the length of the test strip is 5-8 cm, the length of the sample pad 6 is 1-3 cm, and the sample pad 6 is arranged at a position corresponding to the vagina.

In the detection, when the content of the corresponding AFP, beta-hCG and IGFBP-1 in vaginal fluid exceeds the corresponding detection threshold, the first detection line 10 and the second detection line 11 are developed (i.e. positive).

Specifically, the first detection line 10, the second detection line 11 and the quality control line 12 are positive at the same time, which indicates that the detected vaginal fluid is amniotic fluid and the rupture of the fetal membranes of the pregnant women occurs, and needs to be handled in time.

And when the first detection line 10 is positive, the second detection line 11 is negative and the quality control line 12 is positive, determining that the urine is urine.

When the first detection line 10 is negative, the second detection line 11 is positive, and the quality control line 12 is positive, the detection result is judged to be suspected amniotic fluid, and the retest is required.

When the first detection line 10 is negative, the second detection line 11 is negative, the quality control line 12 is positive, and the other liquid is judged.

When the quality control line 12 is negative, whether the results of the first detection line 10 and the second detection line 11 are negative or positive, the detection is regarded as a failure, and a retest is required.

Any two of AFP, beta-hCG and IGFBP-1 are used as bivalent reagents for synchronous detection, the specificity is high, the interference of urine and other liquid on the detection can be effectively eliminated, the accuracy of amniotic fluid detection is improved, and the probability of detecting false positive is reduced.

The invention also provides disposable underpants with the pad for detecting premature rupture of membranes, the disposable underpants are provided with the pad for detecting premature rupture of membranes, and the pad can be fixed on the crotch of the disposable underpants in an adhesive or other modes.

The present invention is not limited to the above-mentioned preferred embodiments, and any other products in various forms can be obtained by anyone with the teaching of the present invention, but any changes in the shape or structure thereof, which have the same or similar technical solutions as the present invention, are within the protection scope.