HIV-1 Quantitative Real-time RT-PCR
Human Immunodeficiency Virus (HIV) is the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS). Quantitative measurement of HIV levels in peripheral blood has been shown to be an essential parameter in prognosis and management of HIV infected individuals. Decisions regarding initiation or changes in antiretroviral therapy are guided by monitoring plasma HIV RNA levels (viral load), CD4+ T cell count, and the patient’s clinical condition. The goal of antiretroviral therapy is to reduce the HIV virus in plasma to below detectable levels of available viral load tests.
The HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV type 1 (HIV-1) RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is a nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma.
Detects and quantitates all known HIV-1 groups M, N, and O, as well as non-B subtypes. Rebaselining not required with current HIV-1 viral load tests (correlation coefficient, 0.936).
Specificity was evaluated at three external sites by testing 514 HIV-1 seronegative plasma specimens from volunteer blood donors. HIV-1 RNA was not detected for all 514 specimens and the Real-time HIV-1 assay specificity was estimated to be 100% (514/514), 95% CI 99.28 to 100%.
1 - 4 business days from receipt of specimen.
|Specimen Type||Order Code||CPT Code||NY Approved||Volume||Assay Range||Special Instructions|
2mL (min. 1mL)
20 Copies/mL to 1.00x107 Copies/mL
Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.
Plasma received ambient, whole blood not separated from plasma within 24 hours of collection.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
Package Insert; COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0