One Step HIV Rapid Test Kit

Intended use

The HIV 1/2 Rapid Test Device (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HIV-1/HIV-2 in serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HIV infection.

Test principle

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sensegenomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and HIV-2 elicit immune response. Detection of HIV antibodies in serum or plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV.

Test Procedure
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Testing: Transfer 2 drops of serum/plasma to the specimen well of the device with a disposable pipette provided in the kit and add 1 drop of buffer,then start the timer. Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
   As the test begins to work, you will see color move across the membrane.
2. Test Results: Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.