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HIV-1 RNA Quantitative, PCR
MessageSendout, Mayo test code: HIVQN
Test Code
LAB919
Alias/See Also
Acquired Immune Deficiency Syndrome (AIDS)
AIDS (Acquired Immune Deficiency Syndrome)
HIV (Human Immunodeficiency Virus)
HIV-1 (Human Immunodeficiency Virus-1) RNA, Viral Load
HIV-1 PCR
HIV-1 Quantitation, PCR
Human Immunodeficiency Virus, PCR
PCR, HIV-1 Quantitation
HIV viral load
HIV-1 viral load
HIV- RNA
HIVQN
AIDS (Acquired Immune Deficiency Syndrome)
HIV (Human Immunodeficiency Virus)
HIV-1 (Human Immunodeficiency Virus-1) RNA, Viral Load
HIV-1 PCR
HIV-1 Quantitation, PCR
Human Immunodeficiency Virus, PCR
PCR, HIV-1 Quantitation
HIV viral load
HIV-1 viral load
HIV- RNA
HIVQN
CPT Codes
87536
Preferred Specimen
1.5 mL plasma from a lavender EDTA tube.
Minimum Volume
0.8 mL
Other Acceptable Specimens
Plasma separator tube (PST)
Instructions
1. Centrifuge blood collection tube and aliquot plasma into plastic vial per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Freeze aliquoted plasma for shipment.
2. Freeze aliquoted plasma for shipment.
Transport Container
Plastic vial
Transport Temperature
Frozen
Specimen Stability
Frozen (preferred): 84 days
Refrigerated: 6 days
Refrigerated: 6 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis: OK
Gross lipemia: OK
Gross icterus: OK
Gross lipemia: OK
Gross icterus: OK
Methodology
Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
FDA Status
Approved
Setup Schedule
Monday through Saturday
Report Available
1-3 days
Limitations
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 U.S. 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 of age 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, <100-fold (<2 log) changes in plasma HIV-1 viral load should not be considered significant changes.
Viral load results of below 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 (> or = 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.
Although this quantitative HIV-1 RNA test is not FDA-approved for diagnostic purposes, the U.S. 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 of age 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, <100-fold (<2 log) changes in plasma HIV-1 viral load should not be considered significant changes.
Viral load results of below 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 (> or = 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.
Reference Range
Included with report
Clinical Significance
Diagnosis of HIV-1 infection in individuals with acute or early HIV-1 infection
Diagnosis of HIV-1 infection in infants under 2 years of age born to mothers living with HIV-1
Quantifying plasma HIV-1 RNA levels (viral load) in individuals living with HIV-1:
-Before initiating anti-HIV-1 drug therapy (baseline viral load)
-Who may have developed HIV-1 drug resistance while on anti-HIV-1 therapy
-Who may be noncompliant with anti-HIV-1 drug therapy
Monitoring HIV-1 disease progression before or during antiretroviral drug therapy
Diagnosis of HIV-1 infection in infants under 2 years of age born to mothers living with HIV-1
Quantifying plasma HIV-1 RNA levels (viral load) in individuals living with HIV-1:
-Before initiating anti-HIV-1 drug therapy (baseline viral load)
-Who may have developed HIV-1 drug resistance while on anti-HIV-1 therapy
-Who may be noncompliant with anti-HIV-1 drug therapy
Monitoring HIV-1 disease progression before or during antiretroviral drug therapy
Performing Laboratory
Mayo Clinic Laboratories, Rochester, Minnesota
Additional Information
HIV-1 RNA Detection and Quantification, Plasma
