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Test Code LAB3240 HIV-1 RNA Detection and Quantification, Plasma


Shipping Instructions


1. Ship specimen frozen on dry ice.

2. If shipment will be delayed for more than 24 hours, freeze plasma specimen at -20 to -80° C until shipment on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube and aliquot plasma into a plastic vial per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Freeze aliquoted plasma for shipment.


Secondary ID

113581

Useful For

Quantifying plasma HIV-1 RNA levels (viral load) in individuals living with HIV-1:

-Before initiating antiretroviral therapy to obtain baseline viral load

-Who may have developed HIV-1 drug resistance while on antiretroviral therapy

-Who may be noncompliant with antiretroviral therapy

 

Monitoring HIV-1 disease progression before or during antiretroviral drug therapy

Method Name

Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Reporting Name

HIV-1 RNA Detect/Quant, P
Arnot Health Laboratories Note:

HIV Viral Load

Specimen Type

Plasma EDTA

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma EDTA Frozen (preferred) 84 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Reference Values

Undetected

Cautions

This test is not licensed by the US Food and Drug Administration (FDA) as a screening test for HIV-1 infection in donors of blood, human cells, tissues, or tissue products.

 

Although this quantitative HIV-1 RNA test is not FDA-approved for diagnostic purposes, the US Department of Health and Human Services Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommends the use of molecular-based assays to detect HIV-1 RNA or proviral DNA for the diagnosis of HIV infection in infants under 2 years and born to HIV-infected mothers.

 

A single HIV-1 viral load test result should not be used as the sole criterion in guiding therapeutic decisions and intervention in the clinical care of individuals living with HIV-1. Viral load results should be correlated with patient symptoms, clinical presentation, and CD4 cell count. Due to the inherent variability in the assay, physiologic variation, and concurrent illnesses in the infected patients, less than 100-fold (<2 log) changes in plasma HIV-1 viral load should not be considered significant changes.

 

Viral load results of less than 20 copies/mL do not necessarily indicate absence of HIV-1 viral replication. Inhibitory substances may be present in the plasma specimen, leading to negative or falsely low HIV-1 RNA results. Improper specimen collection or storage may lead to negative or falsely lower plasma viral load results.

 

Although this commercial HIV-1 viral load assay is optimized for quantification of plasma viral load in HIV-1 infection due to HIV-1 groups M (subtypes A to H) and O strains, results generated from HIV-1 group O strains may be discordant (≥ 0.5 log copies/mL) with those obtained from other commercially available HIV-1 viral load assays. The assay is not reliable for quantifying plasma viral loads in infection caused by HIV-1 group N and HIV-2 strains.

 

ACD plasma specimens are not optimal for HIV-1 viral load testing because such plasma specimens show HIV-1 RNA levels that are approximately 15% lower than those collected in tubes containing EDTA. Plasma specimens stored frozen in plasma preparation tubes (PPT) are not suitable for HIV-1 viral load testing due to falsely high viral load results from release of intracellular HIV-1 nucleic acids (DNA and RNA) during the freezing process.

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87536

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIVQN HIV-1 RNA Detect/Quant, P 70241-5

 

Result ID Test Result Name Result LOINC Value
113581 HIV-1 RNA Detect/Quant, P 70241-5

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send Microbiology Test Request (T244) with the specimen.