INTRODUCTION

The HPV 16/18 E7 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection HPV 16/18 E7 Protein in female cervical swab specimens. It is intended to be used as an aid in the diagnosis of cervical pre-cancer or cancer including HPV types 16 and 18 (E7). The test only provides preliminary screening results but not critical diagnosis criteria. Any reactive specimen with the HPV 16/18 E7 Antigen Rapid Test must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use.

INTENDED USE

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 year1 . 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)2 . 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-based3 . 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 screens3 . Expression of HPV E7 oncoprotein is essential for the occurrence of transformation of cervical cell. Some researches and study had reported that E7 oncoprotein has a close correlation to positivity with both severity of cervical histopathology and risk for progression. Therefore, E7 oncoprotein promises to be one of the appropriate biomarkers of HPV-mediated oncogenic activity4,5 . The HPV 16/18 E7 Antigen Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect HPV 16/18 E7 protein in female cervical swab specimen, the test can be performed without cumbersome laboratory equipment, and the results are available at 15-20 minutes.