Centrifuge and separate plasma from cells within 6 hours into a plastic vial. Refrigerate. Freeze ≤ -20° C if specimen cannot be assayed within 5 days. May be frozen and thawed up to 5 times.
Stability:
24 hours ambient, 5 days refrigerated, or frozen indefinitely.
Standard Volume:
3 mL plasma.
Minimum Volume:
2 mL plasma.
Transport:
Refrigerated or frozen ≤-20° C.
Comments:
This test should be used only in patients with documented HIV-1 infection. It is not intended for use as a screening test for HIV, or as a diagnostic test to confirm the presence or absence of HIV infection. Assay methodology is Real-Time Polymerase Chain Reaction (RT-PCR) as performed using the FDA approved Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test. This test may be used in conjunction with clinical presentation and used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The analytic measurement range of this assay is 48-10,000,000 copies/mL (1.68 to 7.00 log copies/mL).
Rejection Criteria:
Serum; heparinized specimen; specimen held ambient longer than 24 hours; specimen frozen/thawed more than 5 times; pearl top tube (plasma preparation tube).
MEDICARE MAY REQUIRE A SIGNED ADVANCE BENEFICIARY NOTICE (ABN) FOR THIS TEST
Print View Attached Docs: