Bacterial Vaginosis Rapid Test Kit (Polyamine Method)

Rapid Diagnostic Kit for Bacterial Vaginosis (Polyamine Method) – Instruction Manual
[Product Name] Bacterial Vaginosis Rapid Test Kit (Polyamine Method)
[Package Specification] 20 servings/box
[Intended Use] For the rapid screening of bacterial infections in vaginal secretions in gynecology.
Bacterial vaginosis (BV) is one of the most common gynecological conditions, primarily caused by a reduction in the normal vaginal microbiota, with certain pathogenic anaerobic bacteria replacing or outnumbering the normal flora.
[Principle of Assay] Based on the specific biochemical reactions characteristic of bacterial vaginosis, this assay employs the amine test method and incorporates cutting-edge membrane‑based technology. Through a multi‑step amplification process and by monitoring color‑change indicators, it has been scientifically developed on the basis of clinical trials.
[Main Components] The kit consists primarily of a test card, a sampling pen, and accompanying reagents. The test card comprises a base and a cover; the base features a reaction well lined with absorbent filter paper, while the cover includes a reaction window sealed with a white membrane. The included reagents consist of sample extraction solution, positive control solution, negative control solution, and reaction solution.
Kit components:
1. 20 test cards
2. Sample extract, 20 mL × 1 bottle
3. BV reaction solution, 10 mL × 1 bottle
4. Negative control solution, 2 mL × 1 vial
5. Positive control solution, 2 mL × 1 vial
6. 20 pipette tips
7. One BV test pen
8. One copy of the instruction manual
[Storage Conditions and Shelf Life] Store the kit at room temperature in a dry, non-corrosive environment. The shelf life is 12 months. The date of manufacture is indicated on the outer carton or label.
[Specimen Requirements] Collect samples using a sterile swab according to standard procedures, and collect as much vaginal discharge as possible into a small test tube.
[Testing Method]
1. Specimen Preparation: Add 5 drops of the sample extraction solution to the small test tube containing the vaginal secretion swab, squeeze the swab against the tube wall, and shake vigorously to extract the specimen, thereby preparing the specimen extract.
2. Remove the test card, use a pipette to draw 3 drops of the specimen extract, and add them to the sample well of the test card. Slightly tilt the end of the sample well toward the specimen extract to ensure complete absorption, then add 3 drops of BV reaction solution and allow the reaction to proceed for 2 minutes.
3. Use the BV test pen to draw a line on the display window film, and observe the color change of the line within 2 minutes.
                          
① Add 3 drops of the specimen extract to the sample well. ② Then add 3 drops of BV reaction solution to the sample well. ③ After 2 minutes, observe the results by drawing a line.
[Interpretation of Test Results]
A test card is considered positive if the line within the display window changes from dark green to bluish‑purple; it is considered negative if there is no change or if the color turns yellow‑green. Observations beyond the specified time limit are invalid. The intensity of the color can be used to assess the strength of the result: a darker shade indicates a strong positive, suggesting a more severe condition, while a lighter shade indicates a weak positive, suggesting a milder condition.
[Limitations of the Analytical Method]
1. Improper handling during specimen collection may affect test results; specimens should be tested as soon as possible after removal, as prolonged storage can reduce assay sensitivity.
2. Contraindicated in women during menstruation and those with threatened abortion; also contraindicated after vaginal administration or irrigation.
3. Prior to sampling, patients must not use vaginal creams or perform vaginal douching within 24 hours; do not collect vaginal secretions from the cervical area.
[Product Performance Specifications]
Both negative and positive control tests must achieve 100% concordance; the response time for positive results should be within 2 minutes; accuracy must be no less than 90%; and intra‑batch and inter‑batch precision must be no less than 90%.
[Precautions]
1. This product is intended for in vitro diagnostic use only, is for single use, and should not be used if the packaging is damaged.
2. After use, this product shall be disposed of in accordance with the regulations of the hospital or the environmental protection authorities.
3. Read the instruction manual carefully before use and use within the expiration date.
4. This product employs a dual‑membrane technology; during testing, you may not be able to visually detect the sample entering the reaction chamber—do not assume that no sample has been added. When lifting the sample‑application end of the test card, avoid immersing the specimen extract or reaction solution into the display window’s filter membrane; if this occurs, repeat the test.
5. Specimens and reagents used in the assay may pose potential hazards; handle them with care during testing, and if contact occurs, immediately wash the affected area with soap and water or an appropriate disinfectant.
[Explanation of the Logo]
1. Do not reuse; do not use if the packaging is damaged.
2. Product name and packaging specifications (see packaging).
3. Name of the manufacturing unit, registered production address, and contact information (see packaging).
4. Refer to the packaging for the applicable standard number and product registration number.
5. Production date or batch number, and expiration date (see packaging).
[Basic Information]
Registrant (or Filing Entity)/Manufacturer Name: Zhuhai Special Economic Zone Haitai Biopharmaceutical Co., Ltd.
Address: No. 18, Innovation Fourth Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City, Guangdong Province Postal Code: 519085
Contact Information: Phone: 0756-3890858 Fax: 0756-3890848
Name of After-Sales Service Provider: Zhuhai Haitai Biopharmaceutical Co., Ltd.
Contact Information: Customer Technical Service Phone: 0756-3890835
E-mail: haitai@zhhaitai.com
Company website: www.zhhaitai.com
Production Address: No. 18, Innovation Road No. 4, Gangwan Avenue, Tangjiawan Town, Zhuhai City, Guangdong Province
Production License Number or Production Filing Certificate Number: Yue Food and Drug Administration Medical Device Production License No. 20040941
[Medical Device Registration Certificate Number/Product Technical Requirements Number]
[Date of Approval and Amendment of the Instruction Manual]