Colloidal Gold Human Papillomavirus Hpv Antigen Rapid Test Device

• Type: IVD Reagent
• Component: Rapid Test + Buffer + Swab
• Specimen: Cervical Swab
• Result Time: Within 5 Mins
• Storage: 2~30 º C
• Principle: Immunochromatography
• Model NO.: HPV
• Shelf Life: 24 Months
• Transport Package: 25tests/Box
• Specification: 1000tests/carton
• Trademark: Dewei
• Origin: China

Product Description

Storage	2~30 º C
Specimen	Cervical Swab
Component	Rapid Test + Extraction Buffer + Swab
Principle	Colloidal gold rapid tests
Reading	Within 5mins
Package	25tests/box
Trademark	Dewei
Origin	China

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.

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.

OPERATION

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 2-3 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 OF RESULTS
Positive (+)
Two colored bands appear on the membrane. 
Negative (-)
Only one colored band appears, in the control region (C).  
Invalid
Control band fails to appear. 

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