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HelpTest Code HIVDR HIV-1 Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma
Ordering Guidance
This test is intended for detection and identification of drug resistance-associated HIV-1 genotypic mutations in plasma specimens of individuals prior to or while receiving combination antiretroviral therapy.
Prior to requesting this test, patients must have a confirmed plasma HIV-1 RNA level (ie, viral load) of 1000 copies/mL or higher within the preceding 30 days. HIVQN / HIV-1 RNA Detection and Quantification, Plasma is available to provide this prerequisite test result. Alternately, if the patient's viral load is unknown, order HIQDR / HIV-1 RNA Quantification with Reflex to Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma, which will perform viral load followed by genotype, if appropriate.
For initial diagnosis of HIV, order HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma.
Additional Testing Requirements
Shipping Instructions
If shipment will be delayed for more than 24 hours, freeze plasma specimen at -70° C (up to 60 days) until shipment on dry ice.
Necessary Information
The following ask-at-order entry question must be answered at the time of test ordering (mark answer on the test request form if not ordering electronically):
HIV-1 RNA level copies/mL in last 30 days = (select answer option)
<1000
1000 to 1,000,000
1,000,001 to 10,000,000
>10,000,000
Note: Test requests for submitted specimens with less than 1000 copies/mL (not sufficient amount for testing), “No,†or no response entered will be canceled.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 2.2 mL
Collection 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.
Additional Information: Specimens submitted for HIV-1 genotyping must contain 1000 copies/mL or more of HIV-1 RNA.
Useful For
Identifying HIV-1 genotypic mutations associated with resistance to nucleotide and non-nucleoside reverse-transcriptase inhibitors, protease inhibitors, and integrase strain transfer inhibitors
Guiding initiation or change of combination antiretroviral therapy in individuals, including children, with HIV-1 infection
Method Name
Reverse Transcription Polymerase Chain Reaction (RT-PCR) followed by Targeted Next-Generation Sequencing (NGS)
Reporting Name
HIV-1 Genotypic Drug Resistance, PSpecimen Type
Plasma EDTASpecimen Minimum Volume
0.8 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Frozen (preferred) | 60 days | |
| Refrigerated | 7 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Clinical Information
Antiviral resistance may compromise the efficacy of antiretroviral therapy (ART) in patients receiving such therapy for HIV1 infection. When combination therapy fails, detection and analysis of antiviral drug resistance-associated viral genotypic mutations can guide necessary changes to ART to suppress viral replication (ie, reduce viral load), thereby improving patient outcome.
HIV-1 is an RNA virus that infects cells and is then converted to complementary DNA by the action of the viral reverse transcriptase (RT) gene product. RT has little proofreading capacity and therefore, incorporates errors in the proviral DNA. These errors are transcribed into infectious viral particles when the proviral DNA is transcribed into RNA. Similarly, the enzyme protease catalyzes a polyprotein to produce peptides necessary for active viral replication. Although ART (combination of nucleoside and nonnucleoside reverse-transcriptase inhibitors, protease inhibitors, and/or integrase strain transfer inhibitors) may be effective in reducing the viral load, genotypic mutations arising in the drug-targeted HIV-1 genome due to selective pressure from antiviral therapy will result in antiviral resistance that may compromise such therapy.
Amplification and analysis of drug-targeted HIV-gene sequence allows identification of changes in nucleotide bases and associated amino acid codons that may cause antiviral drug resistance. Such genotypic changes are deemed as variants by comparing the sequence data of the patient's HIV strain to those of a wild-type HIV strain. The significance of these genotypic mutations in relation to antiviral resistance is then determined by a set of interpretive rules developed by a consensus panel of leading experts in the field of HIV-1 resistance. Relevant data presented at a recognized scientific conference or published in peer-reviewed journals are considered by the consensus panel in developing these rules. When necessary, reliable unpublished drug resistance data known to consensus panel members may be considered in the process. The interpretive rules are updated by the consensus panel annually after reviewing newly published data on HIV-1 genotypic drug resistance mutations.
Reference Values
An interpretive report will be provided.
Day(s) Performed
Monday through Friday
Report Available
3 to 10 daysPerforming 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
0219U
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.