Product Description
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
• 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 (15-30ºC) or refrigerated(2-8ºC)for 24 hours. Do not freeze. All specimens should be equilibratedtoroomtemperature (15-30ºC ) 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.
For further operation or performance details, please refer to final instruction manual.
Detailed Photos
Company Profile
Dewei Medical Equipment Co.,Ltd was one of the earliest high-tech biological companies focusing on rapid diagnostics in China. it is a professional manufacture and exporter in the area of medical lines.Factory is located in Foshan city ,Guangdong Province.
Dewei Medical Equipment Co.,Ltd was one of the earliest high-tech biological companies focusing on rapid diagnostics in China. it is a professional manufacture and exporter in the area of medical lines.Factory is located in Foshan city ,Guangdong Province.
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FAQ
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.
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