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HelpTest ID HIVP HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma
Useful For
Virologic detection of HIV-1 infection in infants <18 months of age (an age group for which serologic tests are unreliable) born to HIV-1-infected mothers
Early detection of acute HIV-1 infection in children and adults who may be receiving combination antiretroviral prophylaxis or pre-emptive treatment
Determining eradication of HIV-1 in individuals receiving combination highly active antiretroviral therapies
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
Special Instructions
Method Name
Real-Time Polymerase Chain Reaction (PCR)
(PCR is utilized pursuant to a license agreement with Roche
Molecular Systems, Inc.)
Reporting Name
HIV-1 DNA / RNA Qualitative, PSpecimen Type
Plasma EDTACollection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Spin down and remove plasma from cells within 6 hours of draw.
2. Ship plasma on ice packs if arrival at MML is expected within 5 days of plasma separation. Otherwise, follow step 3 below.
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/media/customer-service/forms/general-request-form.pdf).
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Plasma EDTA | Frozen (preferred) | 35 days |
| Refrigerated | 5 days |
Clinical Information
Human immunodeficiency virus (HIV)-1 infection is usually confirmed by detection of HIV-1-specific antibodies in serum. However, serologic testing may not reliably identify HIV-1 infection in neonates with passively acquired maternal HIV-1 antibodies or with incompletely developed immune systems, individuals with early HIV-1 infection (<30 days from infection), or individuals with "indeterminate" HIV-1 antibody results by supplemental serologic assays. In these situations, detection of HIV-1 nucleic acids (RNA or proviral DNA) by PCR can provide definitive, early evidence of HIV-1 infection (approximately 10 to 14 days after infection), when results of routine diagnostic assays may be inconclusive.
Upon entry into human cells (including peripheral blood mononuclear cells), the HIV-1 RNA is converted into complementary DNA (cDNA) by reverse transcription. These linear cDNA strands are then integrated into the host cell genome, thus representing the proviral form of HIV-1. mRNA, transcribed from the proviral DNA, is used to synthesize the proteins required to make new viral particles. These proteins and viral RNA are packaged in the host's cytoplasm and released from the cell, completing the life cycle of the virus.
HIV-1 DNA and/or RNA tests are recommended at 14 to 21 days, 1 to 2 months, and 4 to 6 months after birth, in infants born to HIV-1-infected mothers. Breastfeeding infants should be tested at baseline (1 to 2 days), 4 to 6 weeks, 3 months, and 4 to 6 months after birth. Two consecutive positive HIV-1 virologic test results (HIV-1 DNA and/or RNA) are necessary for confirming the diagnosis of HIV-1 infection in infants <18 months of age.
Reference Values
Undetected
Cautions
This assay should not be used as a screening test or primary diagnostic test for HIV-1 infection, except in infants <18 months of age born to HIV-1-infected mothers.
This assay is optimized for the detection of HIV-1 groups M (subtypes A to H), N and O, but it may not detect all HIV-1 group N or O strains.
Diagnosis of HIV-1 infection should not rely solely upon a “Detected" result for HIV-1 DNA and/or RNA. Such a result should be considered in conjunction with patient’s clinical presentation, physical findings, and other diagnostic laboratory tests prior to establishing the diagnosis. An “Undetected" result indicates only the absence of HIV-1 DNA and RNA in the specimen tested and does not exclude the diagnosis of HIV-1 infection. “Undetected" results should be interpreted with caution, considering the patient's risk factors for HIV-1 infection, the analytical sensitivity of the assay, and the group of the infecting HIV-1 strain. Follow-up testing is recommended for high-risk patients with initially “Undetected" test results.
“Undetected" result together with repeatedly positive HIV-1 antibody supplemental test results may be observed in HIV-2 infected individuals. For such patients with risk factors for HIV-2 infection, specific testing for HIV-2 antibodies (serologic) and HIV-2 DNA and/or RNA is recommended.
Day(s) Performed
Varies
Report Available
Monday through Thursday, 1 day; Friday, 3 daysPerforming Laboratory
Mayo Medical Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics 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
87535