Intended use:
The HIV/Syphilis/HBV/HCV Combo Rapid Test is a lateral
flow chromatographic immunoassay for the qualitative
detection and differentiation of hepatitis B surface antigen
(HBsAg) and antibodies to HIV-1, HIV-2, Treponema
pallidum (TP), and hepatitis C virus (HCV) in human serum,
plasma, or whole blood. It is intended to be used by
healthcare professionals to aid in the diagnosis of infection
with HIV, syphilis, hepatitis B virus (HBV), and HCV. Any
interpretation or use of this preliminary test result must
also rely on other clinical findings as well as on the
professional judgment of healthcare providers. Alternative
test method(s) should be considered to confirm the test
result obtained by this device.
Specimen: Blood
