Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Graphical) With Reflex to HIV-1 GenoSure PRIme® or GenoSure Archive®

Casandra

Casandra Test Code LC97231Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 550920CPT Code 87536

Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Graphical) With Reflex to HIV-1 GenoSure PRIme® or GenoSure Archive®

Also known as: HIV-1 Plasma Viremia, HiV-1 RNA Real-time PCR, Quantitative, Reflex to GenoSure Archive®, Reflex to GenoSure PRIme®, Viral Load

Clinical Use

Order Test

Use

Detect and measure HIV-1 in plasma with reflex to GenoSure PRIme® if viral load is greater than or equal to 500 copies/mL or reflex to GenoSure Archive® if viral load is less than 500 copies/mL. The GenoSure PRIme® and GenoSure Archive® assays detect mutations in the HIV viral genes that encode for HIV protease, reverse transcriptase and integrase. Mutations in these genes have been associated with resistance to antiretroviral drugs.

Special Instructions

If the reflex test is performed, additional charges and CPT codes may apply. To avoid delays, it is recommended to submit separate frozen specimens for each test requested when multiple tests are ordered on frozen samples.

Limitations

This procedure should only be used for patients with a documented HIV-1 infection. The results should not be used as the sole criteria for patient management. The test was developed and its performance characteristics determined by Monogram Biosciences and has not been cleared or approved by the FDA.

Test Details

Methodology

PCR-based (Real-time PCR)

Biomarkers

2 components

HIV-1 RNA Quantification • Real-time PCRGenoSure PRIme® and Archive® • Real-time PCR

LOINC Codes

Order Codes

20447-9

Result Codes

20447-9
29541-0
80563-0
80693-5
80694-3
51969-4
80689-3
62364-5
80695-0
8251-1

Result Turnaround Time

4-6 days

Specimen

Plasma

Volume

5 mL

Minimum Volume

3.5 mL

Container

Lavender-top (EDTA) tube, screw-capped polypropylene frozen transport tube

Collection Instructions

Both frozen plasma and frozen whole blood are required. Draw three lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes. Plasma: Centrifuge two tubes within six hours of collection. Remove plasma, transfer to transport tubes, and freeze. Ship frozen.