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Test ID 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

Highlights

This test starts with a US Food and Drug Administration (FDA)-approved reverse-transcription polymerase chain reaction assay to quantify HIV-1 RNA in plasma of individuals with known HIV-1 infection. For specimens that yield HIV-1 RNA levels of 1000 copies/mL or greater, reflex testing is performed using a next-generation sequencing assay to identify HIV-1 antiviral drug resistance-associated codon mutations in patients prior to or while receiving combination antiretroviral therapy to predict the likelihood of a favorable response to current FDA-approved antiretroviral combination therapy.

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, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 55 days
  Refrigerated  5 days

Reference Values

Undetected

Day(s) Performed

Monday through Friday

Report Available

1 to 10 days

Performing 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)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIQDR HIV-1 RNA Quant Reflex to Resist, P 70241-5

 

Result ID Test Result Name Result LOINC Value
616917 HIV-1 RNA Detect/Quant, P 70241-5

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.