VITROS Immunodiagnostic Products HIV Combo Reagent Pack
VITROS Immunodiagnostic Products HIV Combo Reagent Pack is for the simultaneous qualitative detection of antibodies to Human Immunodeficiency Virus types 1, including group M and O, and/or 2 (anti-HIV-1 and anti-HIV-2) and HIV p24 antigen in human serum and plasma (heparin and EDTA) in adults, pregnant women, adolescents and children (as young as 2 years of age), using the VITROS 3600 Immunodiagnostic System.
A reactive test result with the VITROS HIV Combo test does not distinguish between the detection of HIV-1 p24 antigen, antibodies to HIV-1 and antibodies to HIV-2.
The results of the VITROS HIV Combo test, in conjunction with other serological evidence and clinical information, may be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. The VITROS HIV Combo test is not intended for use in screening blood or plasma donors. The effectiveness of the VITROS HIV Combo test for use in routine screening of blood, plasma, cell or tissue donors has not been established. However, this test can be used as a blood donor screening test in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
It is not intended for newborn screening or for use with cord blood specimens or specimens from individuals less than 2 years of age.
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