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HelpTest ID HIVDQ HIV-1 RNA Detection and Quantification, Plasma
Useful For
Diagnosis of HIV-1 infection in individuals with acute or early HIV-1 infection
Diagnosis of HIV-1 infection in infants of <18 months of age born to HIV-1-infected mothers
Quantifying plasma HIV-1 RNA levels (viral load) in HIV-1-infected individuals:
-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 while on or off antiretroviral drug therapy
Testing Algorithm
The following algorithms are available in Special Instructions:
-HIV Testing Algorithm (Fourth Generation Screening Assay) Including Follow-up of Reactive HIV Rapid Serologic Test Results
-HIV Treatment Monitoring Algorithm
Special Instructions
Method Name
Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name
HIV-1 RNA Detect / Quant, PSpecimen Type
Plasma EDTACollection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 2.5 mL
Collection Instructions:
1. Spin down and remove plasma from cells within 6 hours of draw.
2. Freeze plasma specimen immediately, and ship specimen frozen on dry ice. Specimen can be sent refrigerate up to 5 days.
3. If shipment will be delayed for >5 days, freeze plasma specimen at -70° C (up to 35 days) until shipment on dry ice.
Additional Information: This test can be used for detection and diagnosis of HIV-1 infections, including in children <18 months of age when serologic tests are not useful (due to presence of maternal HIV antibodies).
Forms: If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf).
Specimen Minimum Volume
1.2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Plasma EDTA | Frozen (preferred) | 35 days |
| Refrigerated | 5 days |
Clinical 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 >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 HIV-1-infected patients.
HIV serologic tests may be unreliable for infants born to HIV-infected mothers. In infants up to 18 months of age, positive serologic test results can be due to the presence of maternal HIV antibodies. Therefore, the United States Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommends use of proviral DNA or RNA tests for the detection of HIV infection in infants born to HIV-infected mothers.(1)
Reference Values
Undetected
Cautions
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 United States Working Group 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 of <18 months 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 HIV-1-infected patients. 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 <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.
Day(s) Performed
Monday through Saturday; 7 a.m.-4 p.m.
Report Available
Monday through Thursday, 1 day; Friday and Saturday, 3 daysPerforming Laboratory
Mayo Medical Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.CPT Code Information
87536