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Order Code HIQDR HIV-1 RNA Quantification with Reflex to Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma

Additional Codes

EPIC IMO777ia


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.


Secondary ID

616917

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, 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

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Clinical Information

Human immunodeficiency virus-1 (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

Clinical Reference

1. Branson BM, Owen SM, Wesolowski LG, et al. Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Centers for Disease Control and Prevention; June 27, 2014. Accessed January 29, 2025. Available at http://stacks.cdc.gov/view/cdc/23447

2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. US Department of Health and Human Services. Updated September 1, 2022. Accessed January 29, 2025. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

3. Gunthard HF, Calvez V, Paredes R, at al. Human immunodeficiency virus drug resistance:

2018 recommendations of the International Antiviral Society–USA Panel. Clin Infect Dis. 2019; 68(2):177-187. doi:10.1093/cid/ciy463

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

Forms

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