【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.
【INTRODUCTION】
Infection with human papillomavirus (HPV) is a leading cause of cancer among women worldwide with approximately 500,000 new cervical cancer cases and 250,000 deaths each year. Cervical cancer is caused by persistent infection with a group of carcinogenic HPV genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and probably HPV68). The importance of cervical cancer is accentuated by the relatively young average age at incidence and death. Cervical cancer screening strategies have evolved from cytology-based to HPV-based. Following the identification of HPV as the cause of cervical cancer and the development of sensitive HPV tests, HPV-based screening permits the extension of screening intervals and increased impact per number of lifetime screens. The HPV Antigen Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect HPV L1 Capsid protein in female cervical swab specimen, the test can be performed without cumbersome laboratory equipment, and the results are available at 15 minutes.
【PRINCIPLE】
The HPV Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of HPV L1 Capsid Protein in female cervical swab specimens. The membrane is pre-coated with specific monoclonal anti-HPV L1 Capsid antibodies in the test line region. During testing, the extracted specimen reacts with the monoclonal anti-HPV L1 Capsid antibodies particle conjugates precoated on the sample pad to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with the monoclonal anti-HPV L1 Capsid antibodies immobilized in the membrane. If there is enough HPV L1 Capsid Protein in specimens, a colored line will form in the test line region (T). Presence of this colored line indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test cassette
【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.
【MAIN CONTENTS】
• One pouch containing a rapid test cassette with desiccant.
• Swab
• Extraction Tube
• Package insert
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
• Care should be taken to protect the components of this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.
【SAMPLE COLLECTION】
• Consider any materials of human origin as infectious and handle them using standard biosafety procedures. Follow standard laboratory procedures to collect specimens.
• Only female cervical swab specimens can be used to test with the assay.
• The quality of collected specimens is key to the test performance. Detection of HPV L1 Capsid Protein requires a skilled and correct collection technique to enable sufficient cervical epithelial cells are collected by the swab. Note: For the specimen collection procedure two swabs will be needed to collect the specimen every time. Female Cervical Swab Specimen Collection:
• Before specimen collection, remove excess mucus from the endo cervical area with a sterile swab provided in this kit and discard the used swab.
• Insert a new swab provided in this kit into the cervix until only the bottommost fibers are exposed. Firmly rotate the swab 360°for 15-20 seconds in one direction (clockwise or counterclockwise). Withdraw the swab gently and carefully.
• Do not place the swab in any transport test containingmediumsincetransport medium interferes with the assay and viability of theorganismsisnot required for the assay. Place the swab into the extraction tube, if thetestisperformed immediately.
Specimen Storage: It is recommended that specimens be processed as soon as possibleaftercollection. If test is not performed immediately, the swab specimensshouldbe placed in a dry transport tube for storage or transport. The swabmaybestored for 4-6 hours at room temperature (15-30℃) or refrigerated(2-8℃)for 24 hours. Do not freeze. All specimens should be equilibratedtoroomtemperature (15-30℃ ) before testing.
【DIRECTION OF TESTING】
Allow the test, specimen, reagents, and/or controls toreachroomtemperature (15- 30C) prior to testing.
1. Transfer 10 drops (350-400μL) of buffer into extraction tube.
2. Insert the swab after sampling into the extraction buffer tubeandimmersethe entire tip of swab into the extraction buffer, rotate the swabagainsttheinner wall of the tube approximately 10 times to dissolve the specimeninthesolution as much as possible. Squeeze the swab over the swabtip, leavetheswab in the buffer tube for 1 minute.
3. Take out the test cassette from sealed foil pouch and place onadry, cleanand level surface. Use the dropper to transfer 2-3 drops of extractedspecimento the specimen well of the test cassette, and start the timer.
4. Read the results at 15 minutes. Do not interpret the result after 20minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) withintheresultwindow indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result windowindicatesanegative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
【PERFORMANCE CHARACTERISTIC】
The HPV Antigen Rapid Test has been evaluated by comparing with a commercial RT-PCR assay as the reference method using clinical specimens.
Sensitivity (Positive Percent Agreement): 84.0%
Specificity(Negative Percent Agreement): 91.0%
Cross-Reactivity
The antibody used in the HPV Antigen Rapid Test has been shown to detect HPV type 6, 11, 16, 18, 31, 33, 45, 52 and 58. Cross reactivity with other organisms has been studied using suspensions of 10 7 cfu/mL.
For further operation or performance details, please refer to final instruction manual.
Your message must be between 20-3,000 characters!