Human Papillomavirus (HPV) Antigen Rapid Test Cervical Swab
INTENDED USE
The HPV Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of HPV L1 Capsid protein in female cervical swab specimens. It is intended to be used as an aid in the diagnosis of cervical pre-cancer and cancer including types 6, 11, 16, 18, 31, 33, 45, 52 and 58. The test only provides preliminary screening results but not critical diagnosis criteria. Any reactive specimen with the HPV Antigen Rapid Test must be analyzed and confirmed with alternative testing method(s) and clinical findings.
MAIN CONTENTS
• Rapid test cassette with desiccant.
• Swab
• Buffer
• Extraction Tube
• Package insert
PRECAUTIONS
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• The test is only for the detection of HPV L1 Capsid Protein, not for any other viruses or pathogens.
• Avoid cross-contamination of specimens by using a new extraction tube for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in any area where specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Do not interchange or mix reagents from different lots. Do not mix solution bottle caps.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
• Inadequate or inappropriate specimen collection, storage, and transportation are likely to result in false negative test results.
• Do not use cytology brushes with pregnant patients.
STORAGE
1. The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION PROCEDURE
Allow the test, specimen, reagents, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Transfer 10 drops (350-400μL) of buffer into extraction tube.
2. Insert the swab after sampling into the extraction buffer tube and immerse the entire tip of swab into the extraction buffer, rotate the swab against the inner wall of the tube approximately 10 times to dissolve the specimen in the solution as much as possible. Squeeze the swab over the swab tip, leave the swab in the buffer tube for 1 minute.
3. Take out the test cassette from sealed foil pouch and place on a dry, clean and level surface. Use the dropper to transfer 2 drops of extracted specimen to the specimen well of the test cassette, and start the timer.
4. Read the results at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
FRQ:
| 1 |
What happens if you have HPV? |
Certain strains of HPV (most often types 16 and 18) can cause changes in the cells of your cervix, a condition called cervical dysplasia. Your cervix is the opening between your vaginaand your uterus. Left untreated, cervical dysplasia sometimes advances to cervical cancer. |
| 2 |
How long does it take for HPV to turn into cancer? |
Although research has focused on how high-risk HPV causes cancer in the cervix, HPV-caused cancers at other sites are likely to arise through similar mechanisms. Research has found that it can take 5 to 10 years for HPV-infected cervical cells to develop into precancers and about 20 years to develop into cancer. |
| 3 |
How can HPV be spread? |
HPV is most commonly spread during vaginalor anal sex. It also spreads through close skin-to-skin touching during sex. A person with HPV can pass the infection to someone even when they have no signs or symptoms. |
| 4 |
Is HPV an STD? |
HPV is the most common STD, but most of the time it isn't a big deal. It usually goes away on its own, and most people don't even know that they ever had HPV. Remember that most people who have sex get HPV at some point in their lives. |
| 5 |
Can a girl with HPV give it to a guy? |
Some HPV infections can cause genital warts and cancers such as cervical cancer (cancer of the mouth of the womb), cancer of the throat and tonsils and cancer of the anus orpenis. The type of HPV that causes warts does not cause cancers. It is possible for a woman to give a man HPV and vice versa. |
| 6 |
What does HPV look like on a man? |
Genital warts can be small or large, flat or raised, or cauliflower-shaped. They might appear as a bump or group of bumps in the area surrounding thepenis, anus, or genitals. These warts do not often hurt but can be unsightly. HPV is not cancer, but the HPV virus can cause changes in the body that may lead to cancer. |
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