Test Directory

This test is intended for use as an aid in the diagnosis of HIV-1 or HIV-2 infection, including acute or primary infection. Presence of HIV-1 or HIV-2 RNA in the plasma of patients without antibodies to HIV-1 or HIV-2 is indicative of acute or primary HIV-1 or HIV-2 infection. This assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 and/or HIV-2 antibodies. This assay is not intended for use in donor testing.

Specimen Type: Plasma

Alternate Specimen Type: Serum

Collection Container: Lavender Top (EDTA)

Alternate Collection Container: Gold Top, Serum Separator or White Top (EDTA)

Desired Specimen Volume: 1 mL

1. Collect a lavender top (EDTA) tube via venipuncture.

1. Separate plasma from cells within 24 hours of collection.
2. Transfer 1 mL of plasma to a clear aliquot tube (screw cap).

Transport to the laboratory refrigerated.

• Grossly hemolyzed

See patient report.

Due to the potential cross-reactivity between some NAT assays and certain lentiviral vector-based CAR-T cell therapies, clinicians should exercise caution when ordering and interpreting HIV testing in patients who have received CAR-T cell therapy. Some lentiviral CAR-T vectors contain a target region of the test, which can lead to false positive HIV-1 results.

• Human Immunodeficiency Virus 1 & 2 (HIV-1/HIV-2), Qualitative, RNA