【PRODUCT NAME】

HPV 16/18 Antibody Rapid Test Kit 

【PACKING SPECIFICATION】

1 test/Box、5 tests/Box、25 tests/Box、50 tests/Box.

【INTENDED USE】

HPV 16/18 antibody rapid test kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to human papillomavirus (HPV) including HPV type 16 and HPV type 18 in human whole blood, serum or plasma specimens.

【SUMMARY】

Human papillomavirus (HPV) infection is associated with anogenital cancers, oropharyngeal cancers, oral cavity cancers, and laryngeal cancers.  Only a small subset of HPV types is considered oncogenic. Among over 170 types of HPV, HPV type 16 and 18 are the most common oncogenic viruses which cause about 70% cervical cancer.  The US FDA has approved several HPV vaccines, which help human bodies generate antibodies against HPV16, HPV18, and other types of HPV. The presence of IgG antibodies to HPV in human blood, plasma, or serum could indicate the HPV immunization status.

【PRINCIPLE】

The HPV 16/18 Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of IgG antibodies to HPV16 and HPV18 in whole blood, serum or plasma specimen. This kit adopts the principle of colloidal gold chromatographic immunoassay . During testing, the specimen reacts with HPV16 or HPV18 antigen-coated gold particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region, if the specimen contains IgG antibodies to HPV16 or HPV18. A colored line will appear in IgG test line region as a result of this. If the specimen does not contain HPV16 or HPV18 IgG antibodies, no colored line will appear in the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.