Uncut sheet for HIV Ab/P24 Rapid test

The HIV Ab/p24 Rapid Test Device (the “Uncut Sheet ” format for manufacturing use) is   intended for the qualitative detection of antibodies to HIV-1 (including group O) and HIV-2, and HIV-1 p24 antigen in human serum, plasma, venous whole blood.

This test is intended for in vitro diagnostic professional use and serves as an aid in the screening and diagnosis of HIV-1 and HIV-2 infection, including acute HIV-1 infection.

The simultaneous detection of HIV-1/2 antibodies and the HIV-1 p24 antigen allows for earlier diagnosis of HIV infection than tests relying solely on antibody detection, as the p24 antigen may be detectable before seroconversion . The device can help differentiate acute HIV-1 infection from established HIV-1 infection when a specimen is positive for HIV-1 p24 antigen but negative for HIV-1/2 antibodies.

The device provides presumptive screening results. Negative results do not rule out HIV infection, particularly if the specimen is collected during the window period of infection when antibody or antigen levels may be below the detection limit . Positive results are preliminary and should be confirmed by alternative diagnostic methods (e.g., fourth-generation immunoassay, Western blot, or nucleic acid testing) in accordance with current clinical guidelines.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format