Cervical Cancer Rapid Screening Test

The StrongStep® HPV 16/18 Antigen Rapid Test Device is a rapid visual immunoassay for the qualitative presumptive detection of HPV 16/18 E6&E7 oncoproteins in female cervical swab specimens. This kit is intended to be used as an aid in the diagnosis of Cervical Pre-cancer and Cancer.

INTRODUCTION

In developing countries, cervical cancer is a leading cause of cancer related death of women, due to the lack of implementation of screening tests for cervical pre-cancer and cancer. A screening test for low resource settings should be simple, rapid, and cost effective. Ideally, such a test would be informative regarding HPV oncogenic activity. Expression of both HPV E6 and E7 oncoproteins is essential for cervical cell transformation to occur. Some research results demonstrated a correlation of E6 &E7 oncoprotein positivity with both severity of cervical histopathology and risk for progression. Hence, E6&E7 oncoprotein promises to be an appropriate biomarker of HPV-mediated oncogenic activity.

PRINCIPLE

The StrongStep® HPV 16/18 Antigen Rapid Test Device has been designed to detect HPV 16/18 E6&E7 Oncoproteins through visual interpretation of color development in the internal strip. The membrane was immobilized with monoclonal anti-HPV 16/18 E6&E7 antibodies on the test region. During the test, the specimen is allowed to react with colored monoclonal anti-HPV 16/18 E6&E7 antibodies colored particals conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by capillary action, and interact with reagents on the membrane. If there were enough HPV 16/18 E6&E7 oncoproteins in specimens,