Diagnostic Test Directory

Virology Laboratory

HIV-1 RNA quantification (viral load) - plasma specimen

  • Synonyms: HIV-1 RNA Viral Load, , HIV-1 Viral Load, HIV-1 RNA Quantification
  • LIS Mnemonic: HIVRNAQT

    Collect

    PREFERRED: PLASMA is the preferred specimen and Plasma Preparation Tubes (PPT tubes with pearl-white closure and K2 EDTA) are the preferred collection tubes. REMARK: Serum IS NOT an acceptable alte

    Volume Required

    6 ml; Tube must be completely filled

    Minimum Required

    6 ml; Tube must be completely filled

    Transport

    For the CHOP enterprise, submit blood specimens as soon as possible at room temperature to Central Laboratory Services. For outside clients, it is recommended that plasma specimens be removed from the separator gel as soon as possible after collection and before shipping specimens. When shipping plasma specimens, package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. Specim

    Stability

    Specimens should be processed without significant delay. Freshly collected whole blood specimens may be held at 15-30 C (room temperature) for up to 6 hours or at 2-8 C for up to 24 hours prior to pr

    Processing

    Specimens should be processed without significant delay. Freshly collected whole blood specimens may be held at 15-30 C (room temperature) for up to 6 hours or at 2-8 C for up to 24 hours prior to processing. Remove plasma from the cells by centrifuging the PPT collection tube at 1,100 x g for 10-15 minutes. Plasma removed from the whole blood may be stored at 15-30 C for up to 24 hours or at 2-8 C for up to 5 days without significant loss of viral RNA. If longer storage is required, plasma specimens must be stored frozen at -70 C or lower. Multiple freeze-thaw cycles should be avoided and should not exceed three freeze/thaw cycles. Thaw plasma at 15-30 C or at 2-8 C. Once thawed, if plasma specimens are not processed immediately, they can be stored at 2-8 C for up to 6 hours.

    Unacceptable conditions

    Whole blood not collected in EDTA. Whole blood stored at inappropriate temperatures or for longer periods of time than recommended.

Days Performed

Wednesday

Reported

Same day

Reflex Testing

N/A

CPT

87536

Methodology

Amplification and quantification of HIV-1 RNA from the integrase region of the polymerase gene using real-time PCR technology. This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.

Disease Information

Utility:

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease status as an aid in the management of individuals infected with HIV-1. The assay can be used to assess prognosis of disease progression and to monitor the efficacy of antiretroviral therapy by measuring changes in HIV-1 RNA levels in peripheral blood during the course of therapy. The assay can quantify HIV-1 RNA over a range of 40 (1.6 log) to 10,000,000 (7.0 log) copies/ml at a 95% detection rate and provides accurate quantification of all HIV groups and subtypes, including Group M subtypes A-H, Group O, and Group N. The assay is not intended for use as a donor screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.

Interpretation

If positive, quantity of HIV-1 RNA is reported in copies/ml and log10 values. The dynamic range of the assay is 40 copies/ml to 10 million copies/ml

Reference Values

Negative or quantity of HIV-1 RNA is less than the lower limit of detection

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