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HelpTest Code HIQDR HIV-1 RNA Quantification with Reflex to Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma
Ordering Guidance
This test is intended for quantification of HIV-1 RNA level in plasma specimens of individuals with known HIV-1 infection and for identification of drug resistance-associated HIV-1 genotypic mutations prior to or while receiving combination antiretroviral therapy.
Prior to requesting this test, the patient must have a known HIV-1 infection. The following tests are available to screen and confirm the HIV-1 infection status:
-HVCOP / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Plasma
-HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma
If only HIV-1 genotypic mutation testing is needed, order HIVDR / HIV-1 Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma.
Shipping Instructions
1. Ship specimen frozen on dry ice.
2. If shipment will be delayed for greater than 24 hours, freeze plasma specimen at -20 to -80° C until shipment on dry ice.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 3.6 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.
Useful For
Quantifying plasma HIV-1 RNA levels (viral load) in individuals (including children) with known HIV-1 infection, followed by identification of 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
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HIVDR | HIV-1 Genotypic Drug Resistance, P | Yes | No |
Method Name
Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Reporting Name
HIV-1 RNA Quant Reflex to Resist, PSpecimen Type
Plasma EDTASpecimen Minimum Volume
2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma EDTA | Frozen (preferred) | 55 days | |
| Refrigerated | 5 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
Clinical Information
HIV-1 is an RNA virus that infects human host cells and is then converted to complementary DNA by the action of viral reverse transcriptase. HIV-1 is the causative agent of AIDS, a severe, life-threatening condition, and the virus has been isolated from asymptomatic, infected individuals at high-risk for AIDS. Accounting for over 99% of HIV infections 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.
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.
Studies have identified a number of mutations associated with antiviral resistance. Genotypic analysis allows identification of nucleotide changes associated with HIV drug resistance. When combination therapy fails, genotyping for drug resistance mutations may help direct appropriate changes in antiretroviral therapy and may result in at least a short-term benefit, as evidenced by viral load reduction.
Reference Values
Undetected
Day(s) Performed
Monday through Friday
Report Available
1 to 10 daysPerforming Laboratory
Mayo Clinic 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 US Food and Drug Administration.CPT Code Information
87536
0219U (if appropriate)
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.