HPV Antigen Rapid Test Cassette For Cervical Cancer And HPV-16/18 Infection Screening

A rapid test for the qualitative detection of Human Papillomavirus antigen in humancervical swab specimen.

For professional in vitro diagnostic use only.

【INTENDED USE】

The HPV Antigen Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of Human Papillomavirus antigen in human cervical swab specimen as an aid for the screening of cervical cancer and infection of HPV-16/18.

【SUMMARY】

HPVs are distinguished and typed by DNA sequence homology. At least 100 types have been identified. High-risk HPV types can initiate the development of cervical carcinoma and oropharyngeal, esophageal, penile, and anal cancers. Viral DNA is found in benign and malignant tumors, especially mucosal papillomas. Almost all cervical carcinomas contain integrated HPV DNA, with 70% from HPV-16 or HPV-18. The E5, E6, and E7 proteins of HPV-16 and HPV-18 have been identified as oncogenes.1 Human papillomavirus (HPV) is the most common viral infection of the reproductive tract and can cause cervical cancer in women, other types of cancer, and genital warts in both men and women. Including 5 new introductions, 116 Member States have introduced HPV vaccine by the end of 2021. Since many large countries have not yet introduced the vaccine and vaccine coverage decreased in 2021 in many countries, global coverage with the first dose of HPV among girls is now estimated at 15%. This is a proportionally large reduction from 20% in 2019.2

【PRINCIPLE】

The HPV Antigen Rapid Test Cassette (Cervical Swab) is a qualitative, lateral flow immunoassay for the detection of Human Papillomavirus antigen in human cervical swab specimen. In this test, anti-HPV antibody are coated in the test line region of the test. During testing, the HPV antigen specimen reacts with anti-HPV antibody recombinant protein coated particles in the test strip, then the antibody-antigen complex will be

captured with anti-HPV antibody in the membrane when migration. The presence of a colored line in the test line region indicates a positive result for HPV infection, while its absence indicates a negative result for that infection. To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】

The test contains anti-HPV-16 and anti-HPV-18 antibody as the capture reagent, and anti HPV antibody as the detection reagent. A goat anti-rabbit IgG and rabbit IgG are employed in the control line system.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

5. The used test should be discarded according to local regulations.

6. Humidity and temperature can adversely affect results.

7. Do not exchange or mix buffer and test cassettes from kits of different lots.

8. Be sure to add sufficient extracted specimen to the cassette’s specimen well. Invalid result may occur if inadequate extracted specimen is added.

【STORAGE AND STABILITY】

The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

It is recommended to use the swab supplied by the kits manufacture.

l Insert the swab into the inside of the vag/ina, samples are taken at the cervicosquamous junction or transition zone, and rotate for 10 seconds. Pull the swab out carefully.

l Do not place the swab in any transport device containing medium since transport medium interferes with the assay and viability of the organisms is not required for the assay. Put the swab to the extraction tube, if the test is to be performed immediately. If immediate testing is not possible, the patient specimen should be placed in a dry transport tube for storage or transport. The swabs may be stored for 24 hours at room

temperature (15-30 ºC) or 1 week at 2-8 ºC or no more than 6 months at -20 ºC. All specimens should be allowed to reach a room temperature of 15-30 ºC before testing.

l Do not use 0.9% sodium chloride to treat swab before collecting specimen.

【MATERIALS】

Materials Provided

· Test Cassettes

· Package Insert

· Extraction Buffer

· Extraction Tubes · Extraction Tube Tips · Sterile Cervical Swabs

· Workstation

Materials Required But Not Provided

· Timer

【DIRECTIONS FOR USE】

Allow the test, specimen swab, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Add 8 drops (approx. 450 μL) of extraction buffer into the tube.

3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, Leave the swab soak in the extraction tube for 1 minute.

4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.

5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. Add three drops of the solution (approx.100 μL) to the sample well(s) and then start the timer.

6. Wait for the colored line(s) to appear. The result should be read at 15 minutes, do not interpret the results after 20 minutes.

Note: It is suggested not to use the buffer beyond 6 months after opening the vial.