"Clinical Significance
HIV-1 RNA, Quantitative Real-Time PCR with Reflex to Coreceptor Tropism,UDS - This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. This test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

Preferred Specimen(s)
3 mL plasma collected in an EDTA (lavender-top) tube

Alternative Specimen(s)
Plasma collected in: PPT potasium EDTA (white-top) tube

Minimum Volume
2.5 mL

Collection Instructions
Do not freeze whole blood or any samples stored in primary tube. Freshly drawn specimens (whole blood) may be stored at 2-25° C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.

Transport Container
Transport tube

Transport Temperature
Frozen

Specimen Stability
Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: 30 days

Reject Criteria
Gross hemolysis • Lipemia • Serum • Whole blood >24 hours old • Non-centrifuged PPT • Frozen PPT (in situ) • Heparinized plasma

Includes
If HIV-1 RNA, Quantitative, PCR is ≥1000 copies/mL, then HIV-1 Coreceptor Tropism, Ultradeep Sequencing will be performed at an additional charge (CPT code(s): 87906).

Methodology
Real-Time Polymerase Chain Reaction

Reference Range(s)
HIV-1 RNA, QN,PCR    Not detected    copies/mL
HIV-1 RNA, QN, PCR    Not detected    Log copies/mL