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Background
Vaginitis is a group of conditions that cause vulvovaginal symptoms such as itching,
burning, irritation, and abnormal fluids.
Under normal circumstances, aerobic bacteria and anaerobic bacteria colonize the
vagina, forming a normal vaginal micro-ecosystem. If the ecological balance is broken, it
will form various vaginitis which are common clinically .
The market potential is huge due to the huge population with vaginitis .
Characteristics of vaginitis
A chronic disease, annoying but not fatal ; clinic visit is delayed very often;
There are different types of vaginities; They are difficult to be differentiate for non
professionals
It is very time-consuming to visit doctors, and somehow it is also linked with privacy and
life style, which is an issue for female, especially in some countries.
No product can be used at home as a personal health evaluation tool for female at the
moment, except our“Test & Clear”
Characteristics of “Test & Clear”
• CFDA approved;
• Can be delivered and stored at normal temperatures;
• Can be used for non-professionals easily;
• Easy to use, and quickly to get the test results with assistance of kinds of softwares in
handsets, such as “mini program” in Wechat, and APP;
• No need to install any specific equipment;
• Can test and differentiate types of vaginitis at one single testing kit(card);
Instructions for Use Self-testing Card for Female Health
【Product Name】
Self-testing Card for Female Health
【Packing Size】
1 unit / box; 20 units/box; 100 units/box
【Intended Use】
This product is used to detect hydrogen peroxide, sialidase, leukocyte esterase, proline aminopeptidase,
acetylglucosaminidase, oxidase and pH in the secretions of vaginal. Hydrogen peroxide (H2O2) is used to determine
whether the ecologically balanced environment of vaginal is damaged. Sialidase (SNA) is used to determine the
presence of bacterial vaginosis. Leukocyte esterase (LE) is used to determine the presence of inflammation. Proline
aminopeptidase (PIP) is used to determine the presence of bacterial vaginosis. Acetylglucosaminidase (NAG) is used
to determine whether there is trichomonas vaginitis or candida vaginitis. Oxidase (OA) is used to determine the
presence of non-specific vaginitis. The pH value is used to distinguish between trichomonas vaginitis and candida
vaginitis. This product can be used to assess the health status of women's, including micro-ecological environment,
bacterial vaginosis (BV), trichomonas vaginitis, candida vaginitis, non-specific vaginitis, and provide a reference and
evidence for women's self-assessment of health status.
【Main Components】
1 test card,
1 tube of specimen diluent,
1 copy of Instruction for Use,
1 Colorimetric；
Note: Components in different batches of products are not interchangeable.
【Storage conditions and validity period】
1. The kit is stored dry at 2~30 °C (2~8 °C is better), and the validity period is 18 months.
2. After opening the foil package, the self-test card should be used within 1 hour.
Note: Components in different batches of products are not interchangeable.
【Specimen Collection】
1. Non-menstrual specimen, and sexual intercourse, bathing, lavaging, or using medicine for vaginal, should be
prohibited 24 hours before sampling.
2. The specimen should be used as soon as possible, otherwise, the specimen should be stored at 16~25°C and the test
should be completed within 2 hours.
【Principle of Use】
1. Specimen collecting: Use a sterile cotton swab to rotate for 10 to 20 seconds at 1/3 (4-5 cm) inside the vaginal, and
collect as much secretion as possible to clearly see the secretions on the swab.
2. Specimen processing: directly put the sampled swab into the diluent tube and repeatedly squeeze to make the
secretions fully released;
3. Remove the aluminum foil package, take out the test card, and use the pipette to draw the specimen liquid from the
previous step, and add 1 drop to the center of the 7 detection holes of the test card.
4. Wait at the normal temperature (20-25 °C) for 20 minutes, then you can interpret it. The maximum length should
not exceed 30 minutes;
【Interpretation】
1. Use “mini programs” in Wechat to interpret the test results. Open Wechat first, then find “mini programs”in
“Discovery”, and then look up “Test&Clear”; follow the instructions.
2. Use the APP to interpret: Please scan the following QR code to download the “Test & Clear” APP and install it.
Follow the APP instructions.
3. Use colorimetric chart to interpret: move the color card to the left or right for color comparison.
Collecting
Dilution
Dosing
Wait
Interpretation
Interpretation of the results：
“+”means “Positive”；“—”means “Negative；“±”means “Weak Positive”
1. Items 1 to 6 are negative, and the seventh item is ≤ 4.6, which is normal;
2. The first item is weakly positive or positive, and the ecological balance of the vaginal is destroyed;
3. The second item is weakly positive or positive, and there is inflammation in the vaginal;
4. Item 3 or 4 is weakly positive or positive, suspected of bacterial vaginitis;
5. Item 5 is weakly positive or positive, and item 7 is ≥ 4.8, suspected of trichomonas vaginitis;
6. Item 5 is weakly positive or positive, and the seventh item is ≤4.6, suspected of fungal vaginitis;
7. Items 4 and 6 are weakly positive or positive, suspected of non-specific vaginitis;
【Limitations of the Test】
1. This product is intended for use as a one-time health assessment only and not as a sole diagnostic standard.
2. There is a certain degree of subjectivity in the interpretation of the color rendering results.
3. Due to the complexity of the vaginal micro-ecosystem and many interference factors, the positive results should
be combined with other confirmed diagnostic methods and clinical symptoms for certain diagnosis.
4. The test results of each test item of this product are only used as preliminary self-assessment and auxiliary
judgment of the health status of the vaginal.
【Warnings and Precautions】
1. Please read this instruction carefully before use. This product is for health assessment only and is not intended to
be used as a sole tool for clinic diagnosis.
1：H2O2
2：LE
3：SNA
4：PIP
5：NAG
6：OA
7：PH2. Please remove the cover of self-test card carefully. Do not contaminate the reagent block.
3. Please use it within the validity period of the product. After tearing off the aluminum foil packaging bag, the
self-test card should be used within 1 hour.
4. This test card is for one-time use.
5. Do not use if the inner packaging or the test card is damaged.
【Manufacture’s Information】
Registrant / Manufacturer Name: Jiangsu Innovation Biotechnology Co., Ltd.
Production Address: Room 201, 2nd Floor, No. 86-7, Shuanggao Road, Gaochun Economic Development Zone,
Nanjing City.
Phone: 086-25-68162685
Zip code: 211300
Website: www.innvbio.com
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