A sanitary pad for collecting vaginal discharge, a kit, and a method for collection, separation, and detection

Abstract

The present invention relates to a sanitary pad for collecting vaginal discharge, a kit, and a collection, separation, and detection method, belonging to the technical field of collecting vaginal discharge. The sanitary pad of the present invention includes a removable absorbent paper (2). The present invention not only has the advantages of comfortable wearing of the sanitary pad and convenient sample collection, but also has high sensitivity and specificity for subsequent detection, and is particularly suitable for home sampling and detection of female vaginal discharge, benefiting all women.

Description

Technical Field

[0001] The present invention relates to the technical field of vaginal discharge collection, and in particular to a vaginal discharge collection pad, a reagent kit, and a collection, separation and detection method. Background Art

[0002] Vaginal discharge typically includes vaginal mucosal exudate, secretions from the cervical glands and endometrium, secretions from the labia majora and labia sebaceous glands, Bartholin's glands, and blood. Normally, vaginal discharge is a thin, odorless, white paste. The amount varies, depending on age, estrogen levels, and genital congestion. In exceptional circumstances, such as premature rupture of membranes, vaginal discharge may also include leaked amniotic fluid.

[0003] Therefore, vaginal discharge examination has important application value in the diagnosis of female reproductive system infections, tumors, estrogen levels, sexually transmitted diseases, and pregnancy monitoring.

[0004] However, current vaginal discharge tests require women to lie flat in a hospital setting while a medical professional inserts a speculum into their vagina to open it. A long swab is then used to collect samples from the vaginal wall, posterior fornix, or cervical opening. This inconvenient and user-friendly process has limited vaginal discharge tests to symptomatic women in hospitals, preventing them from becoming a universally available test for all women. Summary of the Invention

[0005] The present invention aims to provide a panty liner for collecting vaginal discharge, a kit, and methods for collecting, separating, and testing vaginal discharge. This method combines the advantages of a comfortable panty liner and convenient sample collection with high sensitivity and specificity for subsequent testing. It is particularly suitable for home sampling and testing of vaginal discharge in women, benefiting all women.

[0006] The present invention provides a panty liner for collecting vaginal discharge, the panty liner comprising a removable absorbent paper 2.

[0007] The present invention also provides a panty pad for collecting vaginal discharge, which includes a non-woven fabric surface layer 1, removable absorbent paper 2, dust-free paper 3, a base film 4 and super-slip release paper 5, and a notch 6 for removing the absorbent paper 2 is provided on the panty pad.

[0008] Preferably, when the vaginal discharge is amniotic fluid, the absorbent paper 2 is soaked or sprayed with a color indicator.

[0009] The present invention also provides a kit for collecting and extracting vaginal discharge, which comprises the pad and disposable gloves described in the above technical solution.

[0010] Preferably, when the kit is used for collecting and extracting amniotic fluid, the kit further includes a sample extraction solution.

[0011] Preferably, the sample extraction solution includes disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, and surfactant S17; the mass percentage of disodium hydrogen phosphate in the sample extraction solution is 0.363%, the mass percentage of potassium dihydrogen phosphate in the sample extraction solution is 0.024%, the mass percentage of sodium chloride in the sample extraction solution is 2.8%, the mass percentage of potassium chloride in the sample extraction solution is 0.02%, and the mass percentage of surfactant S17 in the sample extraction solution is 0.3%.

[0012] The present invention also provides a method for collecting and extracting vaginal discharge based on the sanitary pad or the kit described in the above technical solution, including the following steps:

[0013] After using the sanitary pad to collect vaginal discharge, wear disposable gloves, take out the absorbent paper from the sanitary pad, and separate the liquid in the absorbent paper to obtain vaginal discharge.

[0014] Preferably, when the vaginal discharge is amniotic fluid, the absorbent paper is used to separate the vaginal discharge with the sample extraction solution.

[0015] The present invention also provides a kit for collecting, extracting, and detecting vaginal discharge, which includes the sanitary pad, disposable gloves, and reagents / instruments for detecting vaginal discharge described in the above technical solution.

[0016] The present invention also provides a method for collecting, extracting, and detecting vaginal discharge based on the sanitary pad or the kit described in the above technical solution, including the following steps: After using the sanitary pad to collect vaginal discharge, wear disposable gloves, take out the absorbent paper from the sanitary pad, and separate the liquid in the absorbent paper to obtain vaginal discharge; use reagents / instruments for detecting vaginal discharge to detect a certain component of the vaginal discharge.

[0017] The present invention provides a sanitary pad for collecting vaginal discharge. The present invention uses a sanitary pad with a removable absorbent paper to collect the secretions flowing out of the vaginal orifice, and then uses subsequent detection methods to detect the substance to be tested. Existing technologies mostly use a speculum and a long swab to reach into the vagina, the posterior fornix of the vagina, or the cervical os for sampling, and then perform extraction and subsequent detection. The present invention has both the advantages of comfortable wearing of the sanitary pad and convenient sample collection, and high sensitivity and specificity of subsequent detection, and is particularly suitable for home sampling and detection of female vaginal discharge, benefiting all women.

[0018] Specifically, the existing clinical diagnoses of premature rupture of fetal membranes include the following methods: 1) Indigo carmine dye injection test; 2) Determination of vaginal secretion pH value; It can be measured by the test paper method. If the pH test paper turns blue (pH≥6.5), it can assist in the diagnosis because the vaginal pH value is 4.5-5.5, while the amniotic fluid pH value is 7-7.5; 3) Fern-like crystal test of vaginal fluid smear; 4) Ultrasonography; 5) Detection of insulin-like growth factor binding protein-1 (IGFBP-1) in the vaginal posterior fornix secretion; Positive results can assist in the diagnosis. Among them, method 1) is invasive; methods 2) and 3) are greatly interfered by other factors, and both the false negative and false positive rates are relatively high; method 4) is costly and time-consuming, and requires special instruments and operators; method 5) The detection of insulin-like growth factor binding protein-1 (IGFBP-1) in the vaginal posterior fornix secretion has extremely high sensitivity and specificity, and is increasingly favored in clinical applications. The existing insulin-like growth factor binding protein-1 (IGFBP-1) detection kits require pregnant women to come to the hospital, lie flat, and medical staff use a vaginal speculum to insert into the vagina to open the vagina, and then use a long swab to take samples from the vaginal posterior fornix. The whole process is very inconvenient, and the user experience of pregnant women is also very poor, resulting in the detection of insulin-like growth factor binding protein-1 (IGFBP-1) for amniotic fluid leakage only being carried out in the hospital for pregnant women with leakage symptoms, and it cannot be used as a popular detection method to benefit all pregnant women. The existing detection of whether there is amniotic fluid leakage based on the color change of the indicator has relatively high comfort, but low sensitivity and specificity. The present invention uses a pad with special absorbent paper to collect the secretions flowing out of the vaginal orifice, then extracts the amniotic fluid from the absorbent paper, and then uses insulin-like growth factor binding protein-1 (IGFBP-1) to detect amniotic fluid leakage. The present invention not only has the comfort of wearing the pad and the convenience of sampling, but also has very high sensitivity and specificity in the detection of insulin-like growth factor binding protein-1 (IGFBP-1), and is particularly suitable for home sampling detection of amniotic fluid leakage, benefiting all pregnant women. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic structural diagram of the pad provided by the present invention;

[0020] Among them, 1 is a non-woven fabric surface layer, 2 is absorbent paper, 3 is dust-free paper, 4 is a bottom film, 5 is a super-slippery release paper, and 6 is a notch;

[0021] Figure 2 It is a schematic diagram of the pad provided by the present invention (rectangular absorbent paper);

[0022] Figure 3 It is a schematic diagram of the pad provided by the present invention (oval absorbent paper);

[0023] Figure 4 It is a colloidal gold test strip card provided by the present invention. Detailed implementation mode

[0024] The present invention provides a sanitary pad for collecting vaginal discharge. The sanitary pad includes a removable absorbent paper 2. The sanitary pad containing the removable absorbent paper 2 of the present invention can be used for collecting vaginal discharge, is comfortable to wear, convenient for sampling, and can directly detect the vaginal discharge by subsequently taking out the absorbent paper.

[0025] The present invention also provides a sanitary pad for collecting vaginal discharge. The sanitary pad includes a non-woven fabric surface layer 1, an absorbent paper 2, a dust-free paper 3, a bottom film 4, and a super-slippery release paper 5. A notch 6 for taking out the absorbent paper 2 is provided on the sanitary pad. The present invention has no special limitation on the shape and position of the notch 6, and the notch 6 can facilitate the taking out of the absorbent paper 2. Preferably, the present invention tears the non-woven fabric surface layer 1 through the notch 6 to take out the absorbent paper 2. In the present invention, the absorbent paper 2 is preferably fixed between the non-woven fabric surface layer 1 and the dust-free paper 3 by a non-fluorescent glue. The bottom film 4 is fixed under the dust-free paper 3, and the super-slippery release paper 5 is fixed under the bottom film 4. In the present invention, the vaginal discharge includes vaginal secretions, cervical secretions, amniotic fluid, etc., specifically, vaginal mucosal exudates, cervical gland and endometrial secretions, large labial sweat glands, sebaceous gland secretions of the large and small labia, and vestibular gland fluid, and leaked amniotic fluid.

[0026] In the present invention, when the vaginal discharge is amniotic fluid, the absorbent paper 2 is infiltrated or sprayed with a color indicator. In the present invention, the color indicator is preferably an indicator that changes color when encountering water or a substance to be detected. More preferably, the color indicator is an aqueous solution of nitrazine yellow, and most preferably, it is an aqueous solution of nitrazine yellow with a mass percentage content of 0.02%. The use of the color indicator can enable the absorbent paper to indicate whether the sample collection is successful. The indicator of the present invention has good biological safety and can contact the human skin. The absorbent paper of the present invention is preferably infiltrated with the color indicator. Preferably, the absorbent paper is evenly infiltrated into the indicator solution, and after sufficient infiltration, it is spread out and dried in a drying room. When the indicator is sprayed on the surface of the absorbent paper, it is also preferably spread out and dried in the drying room after spraying. The infiltrated absorbent paper has better uniformity and is easier to process for the coil material.

[0027] In the present invention, the absorbent paper 2 is preferably pure cotton paper, and the thickness is preferably 0.3 - 0.5 mm, more preferably 0.3 - 0.46 mm. The absorbent paper of the present invention is preferably in a thin sheet shape. The present invention has no special limitation on the size of the absorbent paper, and it can be determined according to the water absorption demand. The present invention has no special limitation on the shape of the absorbent paper, and it can be set as an oval or a rectangle. When the absorbent paper is a rectangle, the size of the absorbent paper is preferably 7 cm × 3.5 cm. The raw material of the absorbent paper of the present invention is pure cotton paper, which is made into a coil material through pulp preparation, pulping, screening and purification, pressing, drying, rewetting and calendering from pure cotton materials.

[0028] In the present invention, the blotting paper 2 is preferably a non-fluorescent brightening blotting paper.

[0029] In the present invention, the blotting paper 2 is preferably rolled onto the non-woven paper surface of the sanitary pad by adding non-fluorescent glue, and the amount of glue is very small, preferably just enough to fix the blotting paper. In the embodiments of the present invention, the amount of the non-fluorescent glue used is preferably 1 / 3 of the amount of glue used for conventional sanitary pads. Specifically, the general amount of glue used is usually controlled at 0.01-0.1 g / cm 2 , more preferably 0.0324 g / cm 2 . After fixing the blotting paper, a non-woven fabric surface layer is rolled and attached to the blotting paper in the present invention. Preferably, a notch is reserved through a mold for tearing the non-woven fabric surface layer to remove the blotting paper.

[0030] In the present invention, the non-woven paper is preferably 80 g non-woven paper.

[0031] In the present invention, the using method of the sanitary pad preferably includes the following steps: sticking the sanitary pad of the present invention on the underwear. Checking the color of the sanitary pad at regular intervals or when feeling that there is secretion flowing out. When it is found that the indicator of the blotting paper on the sanitary pad changes color, it means that the blotting paper has collected the outflow. The user preferably wears disposable gloves and tears the surface of the sanitary pad from the notch to remove the blotting paper on the sanitary pad to complete the sample collection.

[0032] The present invention also provides a kit for collecting and extracting vaginal outflow, and the kit includes the sanitary pad described in the above technical solution and disposable gloves. The gloves in the present invention are preferably disposable film gloves, preferably of a general size, suitable for different hand shapes and convenient for handling contact samples.

[0033] In the present invention, when the kit is used for collecting and extracting amniotic fluid, the kit further includes a sample extraction solution. In the present invention, the sample extraction solution includes disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, and surfactant S17; the mass percentage of disodium hydrogen phosphate in the sample extraction solution is 0.363%, the mass percentage of potassium dihydrogen phosphate in the sample extraction solution is 0.024%, the mass percentage of sodium chloride in the sample extraction solution is 2.8%, the mass percentage of potassium chloride in the sample extraction solution is 0.02%, and the mass percentage of surfactant S17 in the sample extraction solution is 0.3%. In the present invention, the sample extraction solution is preferably placed in a special dropper bottle. The special dropper bottle has a large white cap for placing absorbent paper and a small cap of another color with a dropper for facilitating the dripping of the vaginal discharge solution after mixing. In the present invention, the preferred dosage of the sample extraction solution for one detection is 3 mL, and every 3 mL of the sample extraction solution is stored in a dropper bottle with a volume of 5 mL or more. The usage method of the sample extraction solution in the present invention preferably includes the following steps: Unscrew the white bottle cap of the dropper bottle containing the sample extraction solution, fold the removed absorbent paper into a paper roll, put it into the sample buffer dropper bottle, tighten the bottle cap and shake it up and down 20 times to ensure that the sample extraction solution is in full contact with the absorbent paper adsorbed with vaginal discharge, dissolve the vaginal discharge in the sample extraction solution, and let it stand still after completion.

[0034] The present invention also provides a method for collecting and extracting vaginal discharge based on the sanitary napkin or the kit described in the above technical solution, including the following steps: After using the sanitary napkin to collect vaginal discharge, wear disposable gloves, take out the absorbent paper from the sanitary napkin, and separate the liquid in the absorbent paper to obtain vaginal discharge. In the present invention, when the vaginal discharge is amniotic fluid, the absorbent paper is used to separate the vaginal discharge with the sample extraction solution.

[0035] The present invention also provides a kit for collecting, extracting, and detecting vaginal discharge, which includes the sanitary napkin, disposable gloves, and reagents / instruments for detecting vaginal discharge described in the above technical solution.

[0036] The present invention also provides a method for collecting, extracting, and detecting vaginal discharge based on the sanitary napkin or the kit described in the above technical solution, including the following steps: After using the sanitary napkin to collect vaginal discharge, wear disposable gloves, take out the absorbent paper from the sanitary napkin, and separate the liquid in the absorbent paper to obtain vaginal discharge; use the reagents / instruments for detecting vaginal discharge to detect a certain component / composition of the vaginal discharge.

[0037] In the present invention, when the kit is used for detecting amniotic fluid, the reagent / instrument for detecting vaginal discharge preferably includes an insulin-like growth factor binding protein-1 colloidal gold test strip card (IGFBP-1 colloidal gold test card). In the present invention, the IGFBP-1 colloidal gold test card is composed of a shell, absorbent paper, a sample pad, a gold label pad, a nitrocellulose membrane, and a bottom plate. When detecting, a control line C line and a detection line T line will appear. The result is judged according to whether the C line and the T line appear. More preferably, the test strip card in the present invention is the test strip card in an insulin-like growth factor binding protein-1 (IGFBP-1) detection kit (colloidal gold method), Jiangxi Nuode Medical Device Co., Ltd., Jiangxi Medical Device Approval No. 20162400246. In the present invention, the usage method of the test strip card preferably includes the following steps: Take out the colloidal gold test strip card, unscrew the small cover on the dropper bottle, and vertically drop 2-5 drops, preferably 3 drops of vaginal discharge solution (sample extract dissolved with vaginal discharge) into the sample adding hole of the test strip card, and read the result in 10 minutes: If both the detection line (T line) and the quality control line (C line) show red, it is judged as a positive result; if only the quality control line (C line) shows red, it is judged as a negative result; if the quality control line (C line) does not show red within 10 minutes (regardless of whether the detection line shows color), the detection is invalid; the test result after more than 10 minutes is regarded as invalid. For the detection of amniotic fluid in the prior art, a long swab is usually used to sample from the posterior fornix of the vagina of pregnant women. Compared with the prior art, the detection method of the kit in the present application not only has the comfort of wearing a sanitary pad and the convenience of sampling, but also has the high sensitivity and specificity of detecting amniotic fluid by insulin-like growth factor binding protein-1 (IGFBP-1), and is especially suitable for home sampling detection of amniotic fluid leakage, benefiting all pregnant women.

[0038] The following further details the sanitary pad for collecting vaginal discharge, the kit, and the collection, separation, and detection methods according to the present invention with specific embodiments. The technical solutions of the present invention include but are not limited to the following embodiments.

[0039] Example 1

[0040] Case comparison of absorbent paper raw materials and production processes:

[0041] 1. Comparative experiment on the water absorption performance of absorbent paper materials

[0042] Experimental purpose: Select absorbent paper materials and sizes with appropriate water absorption speed, water absorption capacity, and water locking property.

[0043] Experimental materials: Absorbent paper with thicknesses of 0.1mm, 0.2mm, 0.3mm, 0.4mm, and 0.5mm, and the materials are all plant fibers (to prevent interference with the detection reaction of certain protein analytes, such as IGFBP-1), including pure wood pulp, pure bamboo pulp, pure straw pulp, and pure cotton pulp. Purified water, pipette gun.

[0044] Experimental procedure: Cut absorbent papers of various thicknesses from different materials, each with a size of 10 cm × 4 cm (this size ensures that an absorbent paper with a thickness of 0.1 mm can absorb 400 μl of liquid), and lay a layer of dry absorbent paper below. Drop 400 μl of purified water respectively, and judge the water absorption speed by observing whether the absorbent paper can completely absorb 400 μl of purified water within 2 s, judge the water absorption capacity by observing and measuring the wet area of the absorbent paper 1 minute after water absorption, and judge the water locking property by observing whether the lower absorbent paper is dry after placing a heavy object (500 g water bag) for 2 s.

[0045] Experimental results: ("++", good; "+", better; "-", poor)

[0046] The results of the water absorption speed are shown in Table 1:

[0047] Table 1 Results of water absorption speed

[0048] 0.1 mm 0.2 mm 0.3 mm 0.4 mm 0.5 mm Pure wood pulp ++ ++ ++ ++ + Pure bamboo pulp ++ + + + + Pure straw pulp ++ + + + + Pure cotton pulp ++ ++ ++ ++ ++

[0049] The results of the water absorption capacity are shown in Table 2:

[0050] Table 2 Results of water absorption capacity

[0051] 0.1 mm 0.2 mm 0.3 mm 0.4 mm 0.5 mm Pure wood pulp - + ++ ++ ++ Pure bamboo pulp - + + + + Pure straw pulp - + + + + Pure cotton pulp - + ++ ++ ++

[0052] The results of the water locking property are shown in Table 3:

[0053] Table 3 Results of water locking property

[0054] 0.1 mm 0.2 mm 0.3 mm 0.4 mm 0.5 mm Pure wood pulp - + + + + Pure bamboo pulp - - - - - Pure straw pulp - - - - - Pure cotton pulp - + ++ ++ ++

[0055] Experimental conclusion: The pure cotton absorbent paper with a thickness of 0.3 - 0.5 mm has a relatively fast water absorption speed, sufficient water absorption capacity, and can lock water without overflowing.

[0056] 2. Embodiment of selecting a dropping bottle

[0057] According to the requirement of diluting 100 times for 30 μl of added sample (one drop of effluent), it is confirmed that the required sample extraction solution is 3 ml. Since absorbent paper for sampling needs to be placed during use, a container with a volume of 5 ml is adopted. To facilitate subsequent sample addition for detection, a dropping bottle should be used. Conduct a test on the rolling / folding of absorbent papers with a size of 10 cm × 4 cm × 0.4 mm for dropping bottles with different orifices. The preferred solution is a dropping bottle with an orifice diameter of 1 cm, and further conduct an experiment on the selection of the absorbent paper size.

[0058] 3. Experiment on the selection of absorbent paper size

[0059] Experimental purpose: Test the sufficiency of water absorption of 400 μl and the convenience of rolling / folding and placing into a dropping bottle (1 cm orifice diameter, 5 ml capacity) for absorbent paper materials of different sizes in the colloidal gold test of a certain protein analyte (such as IGFBP-1).

[0060] Experimental materials: One piece of blotting paper each with dimensions of 10 cm × 4 cm × 0.3 mm, 10 cm × 4 cm × 0.4 mm, 10 cm × 4 cm × 0.5 mm, 7 cm × 3.5 cm × 0.3 mm, 7 cm × 3.5 cm × 0.4 mm, 7 cm × 3.5 cm × 0.5 mm, 6 cm × 3 cm × 0.3 mm, 6 cm × 4 cm × 0.4 mm, 6 cm × 4 cm × 0.5 mm, purified water, pipette, and dropping bottle (1 cm in diameter, 5 ml in capacity).

[0061] Experimental procedure: Lay a layer of plastic backing under blotting papers of each size. Drop 400 μl of purified water onto blotting papers of different sizes respectively. After 5 minutes, try to put them into the dropping bottle by rolling or folding, and observe the water stain remaining on the plastic board of blotting papers of different sizes after 5 minutes of water absorption, and judge the sufficiency of water absorption of 400 μl. Also, observe whether it is convenient to roll or fold and put into the dropping bottle.

[0062] The experimental results are shown in Table 4: ("++", good; "+", better; "-", poor)

[0063] Table 4 Experimental Results

[0064] Size of blotting paper Sufficiency of water absorption Convenient for being rolled or folded and put into a dropper bottle 10 cm × 4 cm × 0.3 mm ++ - 10 cm × 4 cm × 0.4 mm ++ - 10 cm × 4 cm × 0.5 mm ++ - 7 cm × 3.5 cm × 0.3 mm + ++ 7 cm × 3.5 cm × 0.4 mm ++ ++ 7 cm × 3.5 cm × 0.5 mm ++ + 6 cm × 3 cm × 0.3 mm - ++ 6 cm × 4 cm × 0.4 mm - ++ 6 cm × 4 cm × 0.5 mm - +

[0065] Experimental conclusion: The blotting paper with the size of 7 cm × 3.5 cm × 0.4 mm can fully absorb 400 μl of water, is convenient to be rolled / folded and put into the dropping bottle (1 cm in diameter, 5 ml in capacity), and can be used as a suitable size choice for blotting paper. On the one hand, the blotting paper with this length and width can be folded or rolled and put into the dropping bottle, which is convenient for users to operate; on the other hand, the blotting paper with a thickness of about 0.4 mm is easy to fold while ensuring the water absorption capacity.

[0066] 4. Influence of Surfactant S17 in Sample Extraction Solution on the Performance of Colloidal Gold Reagent Card

[0067] In colloidal gold products, different surfactants are usually added to components such as sample pads, gold conjugate pads, and membrane blocking solutions to improve the product performance. In this invention, surfactant S17 (English name RHODASURF ON - 870) is selected and added to the sample extraction solution. Through the detection of 35 urine samples, it is found that S17 can significantly improve the matrix effect and increase the specificity of the colloidal gold reagent card. The results are shown in Table 5.

[0068] Table 5 Influence Results of Surfactant S17 on the Performance of Colloidal Gold Reagent Card

[0069]

[0070]

[0071] 5. Interference Experiment of Absorbent Paper on the Test of IGFBP-1 Colloidal Gold Reagent Card

[0072] Experimental Purpose: To test the interference of absorbent paper materials from different manufacturers on the specificity and sensitivity of IGFBP-1 colloidal gold reagent card detection.

[0073] Experimental Materials: Two pieces each of cotton absorbent paper 1 (fluorescent brightening), cotton absorbent paper 2, cotton absorbent paper 3, pure wood absorbent paper 1 (fluorescent brightening), pure wood absorbent paper 2, and pure wood absorbent paper 3, each piece being 7 cm × 3.5 cm in size, positive samples, negative samples, IGFBP-1 test cards, dropper bottles, sample extraction solution, and pipettes.

[0074] Experimental Content: Drop positive samples and negative samples onto different absorbent papers respectively. Fold the absorbent papers and put them into the dropper bottles containing sample extraction solution, and shake up and down 10 times. For comparison, drop positive samples and negative samples separately into the dropper bottles containing sample extraction solution. After shaking well, drop the above samples into the test cards and observe the results after 10 minutes.

[0075] Experimental Results: ("++", obvious; "+", line appears; "-", none)

[0076] Table 6 Results of the Interference Experiment of Absorbent Paper on the Test of IGFBP-1 Colloidal Gold Reagent Card

[0077] Positive comparison Positive blotting paper Negative comparison Negative blotting paper Pure cotton blotting paper 1 ++ + - - Pure cotton blotting paper 2 ++ ++ - - Pure cotton blotting paper 3 ++ ++ - - Pure wood blotting paper 1 ++ + - - Pure wood blotting paper 2 ++ ++ - - Pure wood blotting paper 3 ++ ++ - -

[0078] Experimental Conclusion: Among absorbent paper materials from different manufacturers, absorbent paper with fluorescent brightening will weaken the positive detection line, and the background of the test card will turn black. Absorbent paper without fluorescent brightening will not affect the specificity and sensitivity of IGFBP-1 detection.

[0079] 6. pH Selection and Biosafety Data of the Indicator, see Table 7.

[0080] Table 7 pH Selection and Biosafety Results of the Indicator

[0081]

[0082]

[0083] Comparison Conclusion: The color change range (pH value) of nitrazine yellow is 5 - 7, which is close to that of amniotic fluid samples (7 - 7.5), facilitating the identification of amniotic fluid, and it has good biosafety and can be in contact with human skin.

[0084] 7. Nitrazine Yellow Concentration Selection Experiment.

[0085] Experimental Purpose: To select a suitable concentration of nitrazine yellow solution for absorbent paper indication.

[0086] Experimental materials: Nitrate nitrogen yellow, pure water, blotting paper, 3 kinds of amniotic fluid samples.

[0087] Experimental content: Nitrate nitrogen yellow solutions with concentrations of 0.01%, 0.02%, 0.03%, 0.04%, and 0.05% were prepared with purified water respectively. After blotting paper was infiltrated and then dried, 3 drops of each of the 3 amniotic fluid samples were dropped onto it to observe the color change.

[0088] The experimental results are shown in Table 8: ("++", obvious yellow (blue) color change; "+", general yellow (blue) color change; "-", poor yellow (blue) color change)

[0089] Table 8 Experimental results of nitrate nitrogen yellow concentration selection

[0090]

[0091]

[0092] Experimental conclusion: When nitrate nitrogen yellow solutions with concentrations in the range of 0.01% - 0.03% were dropped into the samples, the effects were all good. However, considering possible deviations, a nitrate nitrogen yellow solution with a concentration of 0.02% was selected as its color development effect was relatively stable.

[0093] 8. Selection of the nitrate nitrogen yellow solution addition process.

[0094] Experimental purpose: To evaluate a suitable process for adding a 0.02% nitrate nitrogen yellow solution.

[0095] Experimental content: Blotting paper was processed by the processes of infiltration and spraying with a 0.02% nitrate nitrogen yellow solution respectively. After drying, the uniformity of the blotting paper surface, the color of the blotting paper, and the color development effect were compared.

[0096] The experimental results are shown in Table 9: (++ better, + general, - poor)

[0097] Table 9 Experimental results of nitrate nitrogen yellow solution addition process selection

[0098] Infiltration Spraying Uniformity ++ + Color of blotting paper ++ ++ Color development effect ++ ++

[0099] Experimental conclusion: After treatment, the color and color development effect of the blotting paper processed by the infiltration process were the same as those of the spraying process, but the uniformity of the blotting paper processed by the infiltration process was significantly better than that of the spraying process.

[0100] 9. Interference experiment on the influence of nitrate nitrogen yellow concentration and preparation process on the IGFBP-1 colloidal gold reagent card test

[0101] Experimental purpose: To test the interference of nitrate nitrogen yellow concentration and preparation process on the specificity and sensitivity of the IGFBP-1 colloidal gold reagent card detection.

[0102] Experimental materials: Two pieces of blotting paper each of 0.02% and 0.05% nitrazine yellow solution prepared by infiltration and spraying processes, each piece being 7 cm x 3.5 cm in size, positive samples, negative samples, IGFBP-1 test cards, dropper bottles, sample extraction solution.

[0103] Experimental content: Drop positive samples and negative samples respectively onto each piece of blotting paper, fold the blotting paper and put it into a dropper bottle containing sample extraction solution, and shake it up and down 10 times. For comparison, drop positive samples and negative samples separately into a dropper bottle containing sample extraction solution. After shaking well, drop the above samples into the test card and observe the results after 10 minutes.

[0104] The experimental results are shown in Table 10: (++ obvious, + line appears, - none)

[0105] Table 10 Interference experimental results of nitrazine yellow concentration and preparation process on the test of IGFBP-1 colloidal gold reagent card

[0106]

[0107]

[0108] Experimental conclusion: The blotting paper of 0.05% nitrazine yellow prepared by the two processes will weaken the positive detection line, and the blotting paper treated with 0.02% nitrazine yellow process prepared by the two processes will not affect the specificity and sensitivity of IGFBP-1 detection.

[0109] 10. Test of glue for fixing blotting paper

[0110] Experimental purpose: To test the interference of the glue for fixing blotting paper on the test of a certain protein analyte (IGFBP-1).

[0111] Experimental content: Test two kinds of glues for fixing pads for a certain protein analyte (IGFBP-1) to check their interference degree.

[0112] The experimental results are shown in Table 11: (++ obvious, + present, - none)

[0113] Table 11 Test results of glue for fixing blotting paper

[0114]

[0115] Experimental conclusion: Neither of the two glues will cause false positives or false negatives in the test of a certain protein analyte, but the ordinary glue will weaken the quality control line C line, affecting the user's judgment, so a glue without fluorescence should be used.

[0116] 11. Test of the amount of glue for fixing blotting paper on pads

[0117] Purpose of the experiment: To determine the amount of glue required to bond the upper and lower layers of the pad, so as to facilitate the removal of the absorbent paper while ensuring the bonding strength and being able to fix the absorbent paper on the pad.

[0118] Experimental content: Compare the degree of fixing absorbent paper and the ease of removal by adding glue using normal glue amount, 1 / 2 normal glue amount, 1 / 3 normal glue amount, and 1 / 4 normal glue amount.

[0119] The experimental results are shown in Table 12: (++good, +average, -bad)

[0120] Table 12 Test results of the amount of absorbent paper glue used to fix the pad

[0121]

[0122] Experimental conclusion: In normal panty liner process, 1 / 3 of the glue is used on the upper and lower surfaces to achieve better bonding strength, fix the absorbent paper and facilitate the removal of the absorbent paper.

[0123] 12. Interference test of the overall pad manufacturing process on the IGFBP-1 colloidal gold reagent card test

[0124] Experimental purpose: To test the interference of the whole pad on the specificity and sensitivity of IGFBP-1 detection.

[0125] Experimental materials: pads (with pure cotton absorbent paper soaked in 0.02% nitro yellow, the absorbent paper size is 7 cm × 3.5 cm × 0.4 cm), positive samples, negative samples, IGFBP-1 test cards, dropper bottles, sample extraction solution, pipette gun.

[0126] Experimental Procedure: A positive sample and a negative sample are dripped onto a panty liner. After the absorbent paper completely absorbs the sample, the absorbent paper is removed from the panty liner, folded, and placed into a dropper bottle containing the sample extract. Shake the paper up and down 10 times. For comparison, a positive sample and a negative sample are dripped into the dropper bottle containing the sample extract. After shaking, the sample from the dropper bottle is dripped onto the test card and the results are observed after 10 minutes.

[0127] The experimental results are shown in Table 13: (++ obvious, + out of line, - none)

[0128] Table 13 Interference test of the overall pad manufacturing process on the IGFBP-1 colloidal gold reagent card test

[0129] Positive comparison Positive sample pad Negative comparison Negative sample pad C line ++ ++ ++ ++ T line ++ ++ - -

[0130] Experimental conclusion: The materials used in the production of panty liners (including 0.02% nitro yellow solution, pure cotton absorbent paper, non-fluorescent glue for fixing the absorbent paper, and dropper) and the process factors of panty liners production will not affect the specificity and sensitivity of IGFBP-1 detection.

[0131] Comparative Example 1

[0132] Comparison data of the pH amniotic fluid detection pad with the sensitivity and specificity of the present invention

[0133] Take the pH amniotic fluid detection pad product on the market (refer to CN 105699370 B) as a comparative example, and detect 10 amniotic fluid samples and 35 pregnant women's urine samples respectively with the present invention, and compare the sensitivity and specificity. The results are shown in Table 14 and Table 15.

[0134] Table 14 Detection results of the present invention

[0135] Amniotic fluid (n = 10) Urine (n = 35) Test positive 10 2 Test negative 0 33 Sensitivity = 100% Specificity = 94.3%

[0136] Table 15 Detection results of the comparative example

[0137] Amniotic fluid (n = 10) Urine (n = 35) Test positive 9 4 Test negative 1 31 Sensitivity = 90% Specificity = 88.6%

[0138] It can be seen from the above data that the present invention is superior to the comparative example (existing technologies and products) in terms of both sensitivity and specificity. This is crucial for a detection product.

[0139] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A kit for collecting, extracting and detecting amniotic fluid, characterized in that, The kit includes a pad, disposable gloves, a sample extraction solution, and an insulin-like growth factor binding protein-1 colloidal gold test strip; The pad includes a non-woven fabric surface layer (1), a removable absorbent paper (2), dust-free paper (3), a bottom film (4), and a super-slippery release paper (5). A notch (6) for removing the absorbent paper (2) is provided on the pad; the absorbent paper is a non-fluorescent brightening-free pure cotton absorbent paper with a thickness of 0.3-0.5 mm; The absorbent paper (2) is infiltrated or sprayed with a color indicator; the color indicator is a 0.01%-0.03% nitrazine yellow solution; The sample extraction solution includes disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, and surfactant S17; the mass percentage content of disodium hydrogen phosphate in the sample extraction solution is 0.363%, the mass percentage content of potassium dihydrogen phosphate in the sample extraction solution is 0.024%, the mass percentage content of sodium chloride in the sample extraction solution is 2.8%, the mass percentage content of potassium chloride in the sample extraction solution is 0.02%, and the mass percentage content of surfactant S17 in the sample extraction solution is 0.3%.

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