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25500 HIV-1 RNA Detect/Quant, P (HIVQN)

HIV-1 RNA Detect/Quant, P (HIVQN)
Test Code: HIVDQSO
Synonyms/Keywords
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-1 RNA
Test Components
HIV-1 RNA Detection & Quantitation 
HIV-1 Genotypic PR-RT (Test code HIVPR) if needed
Useful For

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

Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ ​EDTA Plasma EDTA Pink Top Tube (PTT) ​​EDTA Lavender Top Tube (LTT) ​1.5 mL ​0.8 mL
Collection Processing Instructions
Spin down and remove plasma from cells within 2 hours of draw, place in a plastic vial. Freeze specimen immediately and ship on dry ice. If shipment is delayed for >24 hours,  freeze plasma at -20 to -80 degrees C until shipment on dry ice.
Specimen Stability Information
Specimen Type Temperature Time
EDTA Plasma​ ​ ​Frozen (Preferred) ​84 days
​Refrigerate ​6 days
Rejection Criteria
​Green Top Tube (Heparin)
Interference

​This test is not licensed by the 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 to be 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.

Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Saturday 1-3 days ​Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Reference Lab
Test Information

Currently, 2 types of HIV, HIV type 1 (HIV-1) and HIV type 2 (HIV-2), are known to infect humans. HIV-1 has been isolated from patients with AIDS, AIDS-related complex, and asymptomatic infected individuals at high-risk for AIDS. Accounting for more than 99% of HIV infection in the world, HIV-1 is transmitted by sexual contact, by exposure to infected blood or blood products, from an infected pregnant woman to fetus in utero or during birth, or from an infected mother to infant via breast-feeding. HIV-2 has been isolated from infected patients in West Africa and it appears to be endemic only in that region. However, HIV-2 also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in its morphology, overall genomic structure, and ability to cause AIDS.

Multiple clinical studies of plasma HIV-1 viral load (expressed as HIV-1 RNA copies/mL of plasma) have shown a clear relationship of HIV-1 RNA copy number to stage of HIV-1 disease and efficacy of anti-HIV-1 therapy. Quantitative HIV-1 RNA level in plasma (ie, HIV-1 viral load) is an important surrogate marker in assessing the risk of disease progression and monitoring response to anti-HIV-1 drug therapy in the routine medical care of individuals living with HIV-1.

HIV serologic tests may be unreliable for infants born to HIV-infected mothers. In infants up to 2 years of age, positive serologic test results can be due to the presence of maternal HIV antibodies. Therefore, the U.S. Department of Health and Human Services Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommends use of HIV RNA or proviral DNA tests for the detection of HIV infection in infants born to HIV-infected mothers.

Reference Range Information
Undetected
Interpretation

​This assay has a plasma HIV-1 RNA quantification result range of 20 to 10,000,000 copies/mL (1.30-7.00 log copies/mL).

An "Undetected" result indicates that the assay was unable to detect HIV-1 RNA in the plasma specimen tested.

A result of "<20 copies/mL" indicates that HIV-1 RNA is detected, but the level present is less than the lower quantification limit of this assay. Due to the increased sensitivity of this assay, patients with previously low or undetectable HIV-1 viral load may show increased or detectable viral load with this assay. However, the clinical implications of a viral load below 20 copies/mL remain unclear. Possible causes of such a result include very low plasma HIV-1 viral load present (eg, in the range of 1-19 copies/mL), very early HIV-1 infection (ie, <3 weeks from time of infection), or absence of HIV-1 infection (ie, false-positive).

A result of ">10,000,000 copies/mL" with the result comment of "HIV-1 RNA level is >10,000,000 copies/mL (>7.00 log copies/mL). This assay cannot accurately quantify HIV-1 RNA above this level" indicates that HIV-1 RNA is detected, but the level present is above the upper quantification limit of this assay.

For the purpose of monitoring patient's response to antiretroviral therapy, the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents defines virologic failure as a confirmed viral load above 200 copies/mL, which eliminates most cases of viremia resulting from isolated blips or assay variability. Confirmed viral load rebound (ie, >200 copies/mL) on 2 separate tests obtained at least 2 to 4 weeks apart should prompt a careful evaluation of patient's tolerance of current drug therapy, drug-drug interactions, and patient adherence.

Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
87536
Synonyms/Keywords
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-1 RNA
Test Components
HIV-1 RNA Detection & Quantitation 
HIV-1 Genotypic PR-RT (Test code HIVPR) if needed
Ordering Applications
Ordering Application Description
​Centricity HIV-1 RNA Detect/Quant, P (HIVQN)
​Cerner HIV-1 RNA Detect/Quant, P (HIVQN)
​COM HIV-1 RNA Detect/Quant, P (HIVQN)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No​ ​EDTA Plasma EDTA Pink Top Tube (PTT) ​​EDTA Lavender Top Tube (LTT) ​1.5 mL ​0.8 mL
Collection Processing
Spin down and remove plasma from cells within 2 hours of draw, place in a plastic vial. Freeze specimen immediately and ship on dry ice. If shipment is delayed for >24 hours,  freeze plasma at -20 to -80 degrees C until shipment on dry ice.
Specimen Stability Information
Specimen Type Temperature Time
EDTA Plasma​ ​ ​Frozen (Preferred) ​84 days
​Refrigerate ​6 days
Rejection Criteria
​Green Top Tube (Heparin)
Interference

​This test is not licensed by the 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 to be 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.

Useful For

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

Test Components
HIV-1 RNA Detection & Quantitation 
HIV-1 Genotypic PR-RT (Test code HIVPR) if needed
Reference Range Information
Undetected
Interpretation

​This assay has a plasma HIV-1 RNA quantification result range of 20 to 10,000,000 copies/mL (1.30-7.00 log copies/mL).

An "Undetected" result indicates that the assay was unable to detect HIV-1 RNA in the plasma specimen tested.

A result of "<20 copies/mL" indicates that HIV-1 RNA is detected, but the level present is less than the lower quantification limit of this assay. Due to the increased sensitivity of this assay, patients with previously low or undetectable HIV-1 viral load may show increased or detectable viral load with this assay. However, the clinical implications of a viral load below 20 copies/mL remain unclear. Possible causes of such a result include very low plasma HIV-1 viral load present (eg, in the range of 1-19 copies/mL), very early HIV-1 infection (ie, <3 weeks from time of infection), or absence of HIV-1 infection (ie, false-positive).

A result of ">10,000,000 copies/mL" with the result comment of "HIV-1 RNA level is >10,000,000 copies/mL (>7.00 log copies/mL). This assay cannot accurately quantify HIV-1 RNA above this level" indicates that HIV-1 RNA is detected, but the level present is above the upper quantification limit of this assay.

For the purpose of monitoring patient's response to antiretroviral therapy, the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents defines virologic failure as a confirmed viral load above 200 copies/mL, which eliminates most cases of viremia resulting from isolated blips or assay variability. Confirmed viral load rebound (ie, >200 copies/mL) on 2 separate tests obtained at least 2 to 4 weeks apart should prompt a careful evaluation of patient's tolerance of current drug therapy, drug-drug interactions, and patient adherence.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Saturday 1-3 days ​Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
87536
For most current information refer to the Marshfield Laboratory online reference manual.