"Clinical Significance
HIV-1 RNA, Qualitative, Real-Time PCR - HIV-1 Qualitative is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) RNA in human serum and plasma by PCR. The test is intended to be used as an aid in diagnosis of HIV-1 infection. Detection of HIV-1 nucleic acid is indicative of HIV-1 infection. The presence of HIV-1 nucleic acid in the plasma or serum of individuals without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection. The HIV-1 Qualitative PCR may also be used as an additional test to confirm the presence of HIV-1 infection in an individual with specimens reactive for HIV-1 antibodies or antigens. The assay may also be used as an aid in the diagnosis of infection with HIV-1 in pediatric subjects and pregnant women. This assay is not intended to be used for monitoring patient status, or for screening donors of blood, plasma, or human cells, tissues, and cellular and tissue-based products (HCT/Ps) for HIV.

Preferred Specimen(s)
1.6 mL serum or plasma collected in an EDTA (lavender-top) tube or potassium EDTA (white-top) tube

Minimum Volume
0.8 mL

Collection Instructions
Separate plasma or serum from the cells by centrifugation within 24 hours after collection. Transfer the specimen to a transport tube. Separated plasma or serum can be sent in the PPT/SST® but cannot be shipped frozen.

Transport Container
Transport tube

Transport Temperature
Frozen

Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 42 days

Reject Criteria
Whole blood • Unspun PPT • Frozen plasma in PPT (white-top) tube in situ • Frozen serum in Serum Separator Tube (SST®) in situ