Casandra

Casandra Test Code MC35872Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID HIVSSCPT Codes 0475, 86701, 86702, 87389, 87535, 87538

HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum

Clinical Use

Use

This test is useful for screening for HIV-1 and HIV-2 infections in nonsymptomatic, nonpregnant individuals older than 2 years. It is not intended for blood donor screening or confirmatory testing. The test employs an electrochemiluminescence immunoassay method and can detect HIV-1 p24 antigen and antibodies against HIV-1 and HIV-2, which are typically undetectable until 6 to 12 weeks following exposure and are almost always detectable by 12 months. However, antibodies may fall to undetectable levels in the terminal stage of AIDS when the patient's immune system is severely compromised.

Special Instructions

Not provided.

Limitations

This assay is not FDA licensed for donor screening of blood, plasma, or tissues. A reactive result does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody and should be considered preliminary pending confirmation. False-reactive results may occur in those receiving experimental HIV-1 vaccines or having mouse monoclonal antibodies. Certain specimen conditions such as gross hemolysis, lipemia, icterus, and heat-inactivated specimens may cause rejection. The test has no biotin interference, and certain concentrations of biotin should not affect results. Performance characteristics have not been established for non-serum specimens, cadaveric specimens, or specimens with particulate matter.

Test Details

FDA Approved