84800:HUMAN IMMUNODEFICIENCY VIRUS (HIV) RNA QUANTITATIVE, BY bDNA 3.0

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84800:HUMAN IMMUNODEFICIENCY VIRUS (HIV) RNA QUANTITATIVE, BY bDNA 3.0
Methodology: Branched Chain DNA (bDNA) 3.0
Edit Date: 2/16/2010
Performed: Wednesday, Saturday
Released: 2-5 days after setup at PeaceHealth Laboratories’ reference lab
CPT Code: 87536-90
Specimen Collection Details
Collection: Two 4 mL lavender top tubes (EDTA). Do not use a polystyrene tube.
Handling: Centrifuge and separate plasma from cells within 4 hours of collection. Freeze. Critical frozen. Avoid repeated freeze/thaw cycles. If multiple tests are ordered, send a separate specimen for this test.
Stability: Plasma on cells: 4 hours ambient; Plasma removed from cells within 4 hours: 48 hours refrigerated; 72 hours frozen at -20° C, or 4 months frozen at -70° C.
Standard Volume: 3 mL plasma.
Minimum Volume: 2.5 mL plasma.
Transport: Frozen on dry ice.
Comments: The quantitative range of this assay is 1.9-5.7 log copies/mL (75-500,000 copies/mL).
NOTE: This test should be used only in patients with documented HIV-1 infection. It should not be used to diagnose HIV-1 infection.
Rejection Criteria: Non-frozen specimen; repeated freeze/thaw cycles; serum; heparinized plasma; Polystyrene tube.
MEDICARE MAY REQUIRE A SIGNED ADVANCE BENEFICIARY NOTICE (ABN) FOR THIS TEST

Reference Range:
An interpretation of “Not Detected” does not rule out the presence of inhibitors in the patient specimen or HIV-1 virus RNA concentrations below the level of detection of the assay. Care should be taken in the interpretation of any single viral load determination. The clinical significance of changes in HIV-1 RNA measurements has not been fully established; however, a change of 0.5 log copies/mL may be significant. Low positive values may occasionally be seen in specimens from patients who are HIV-1 seronegative or whose HIV-1 viral load is actually below the threshold of assay detection (75 HIVE-1 RNA copies/mL).

This assay should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).

The test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. This test is also used as an aid in assessing viral response to antiretroviral treatment as measured by changes in HIV-1 RNA levels.