Diagnostic Test Directory

Virology Laboratory

HIV-1 RNA qualitative assay (for diagnosis) - plasma or serum specimen

  • LIS Mnemonic: HIVMA

    Collect

    PREFERRED: PLASMA is the preferred specimen and Plasma Preparation Tubes (PPT clear tubes with K2 EDTA) are the preferred collection tubes. Other collection tubes containing K2 EDTA, K3 EDTA, Acid Ci

    Volume Required

    4-6 ml; tube should be completely filled, if possible

    Minimum Required

    4-6 ml; tube should be completely filled, if possible

    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 serum or plasma specimens be removed from the clot, red blood cells, or separator gel as soon as possible after collection and before shipping specimens. When shipping serum or plasma specimens, package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical

    Stability

    Whole blood, plasma or serum may be stored up to 72 hours from the time of draw at less than or equal to 25C (room temperature). Temperatures less than or equal to 30C are acceptable for 24 hours. P

    Processing

    Transport specimens to the Clinical Virology Laboratory as soon as possible after collection. Specimens are accepted Monday through Sunday. Whole blood, plasma or serum may be stored up to 72 hours from the time of draw at less than or equal to 25C (room temperature). Temperatures less than or equal to 30C are acceptable for 24 hours. Plasma or serum separated from the cells may be stored an additional 5 days at 2-8C (refrigerator temperature) and may be stored for longer periods of time at -70C before testing. Do not freeze the whole blood.

    Unacceptable conditions

    Clotted specimens, specimens collected in inappropriate blood draw tubes, and specimens that are not transported correctly. Performance has not been established for boody fluids other than human serum or plasma.

    Specimen Handling

    Unprocessed blood specimens should routinely be refrigerated at 4C upon arrival in the laboratory. O

Days Performed

Tuesday, Thursday

Reported

Same day

Reflex Testing

N/A

CPT

87535

Methodology

The Gen-Probe APTIMA HIV-1 RNA Qualitative Assay uses transcription-mediated amplification (TMA) to replicate highly conserved regions of the HIV-1 long terminal repeat (LTR) and POL genomic RNA.

Disease Information

Utility:

This is the first nucleic acid amplification test specifically approved by the Food & Drug Administration (FDA) for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection prior to or at the time of seroconversion. Indications for use of this assay include (a) screening of high-risk populations, (b) testing in the setting of known occupational health exposure, (c) testing patients with acute HIV-1 symptoms and known exposure, and (d) screening newborn babies born to infected mothers. This assay also can be used as a supplemental test for routine screening of all patients being tested for HIV-1 antibodies/antigen, and may be used to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies/antigen. The new test is extremely sensitive, and has detection rates of 98.5% for 30 RNA copies/ml, 82.6% for 10 copies/ml, 42.5% for 3 copies/ml, and 19.4% for 1 copy/ml. The test detects all major groups (M, N, and O) and subtypes of HIV-1, and can detect HIV-1 infection 12 days earlier than current antibody assays. NOTE: The new test should not be used in place of routine HIV antibody/antigen combo screening, but in conjunction with antibody/antigen combo assays. HIV antibody/antigen combo testing remains as the initial frontline diagnostic tool.

Interpretation

A positive test result indicates that HIV-1 RNA was detected. For a patient who is repeatedly reactive in our 4th generation antibody/antigen combo s

Reference Values

Negative or no HIV-1 RNA detected by molecular amplification (TMA)

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