SHINJIN MEDICS INC.

The Human immunodeficiency virus Antibody Test (HIV1/2) (Whole serum or plasma)
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription.

INTRODUCTION

Acquired immunodeficiency syndrome (AIDS) is Secondary immunodeficiency syndrome infected by human immunodeficiency virus(HIV), the feature is obviously decreased of the circulating CD4 T cells, an opportunistic infection and malignant diseases. The group of the virus is a retrovirus in the primate immunodeficiency virus slow virus in genera subgenus. Now it is found that there are two kinds of type, HIV-1 and HIV-2, both Originated in Africa.
HIV-1 have eight subtypes (A-H) and O subtype, because of its highly pathogenicity, it is the main pathogen of the global AIDS epidemic. HIV-2 is lower toxicity and long latency.

PRINCIPLE OF THE ASSAY

The Human immunodeficiency virus Antibody Test (HIV1/2) (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay based on the principle of the double antigen–sandwich technique. The membrane is pre-coated with HIV 1/2 recombinant antigen on the test line region of the test. When testing positive specimen (whole blood, serum or plasma) , the anti-HIV antibody in the specimen reacts with the particle coated with anti-HIV antigen. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HIV antigen on the membrane and generate a coloured line. The presence of this colored line in the test region indicates a positive result, while its absence indicates 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..