Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device)is a single use, rapid device for qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) in whole blood, serum and plasma specimens). Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) is for use in health facilities by trained staff as an aid for the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2 - the etiological agents of the acquired immunodeficiency syndrome (AIDS).
The kit was qualified with examination of national reference panel of anti-HIV antibody for colloidal gold diagnostic kit. The sensitivity was 100% by tested with 20 HIV antibody positive sera, the specificity was 98.5% by tested with 600 HIV antibody negative sera, respectively. The stability of the kit was over 12 month by storage at room temperature.
