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Test 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

Testing Algorithm

For more information see HIV Treatment Monitoring Algorithm

Special Instructions

Method Name

Reverse Transcription Polymerase Chain Reaction (RT-PCR) followed by Targeted Next-Generation Sequencing (NGS)

Reporting Name

HIV-1 Genotypic Drug Resistance, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 60 days
  Refrigerated  7 days

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

3 to 10 days

Performing 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIVDR HIV-1 Genotypic Drug Resistance, P 90901-0

 

Result ID Test Result Name Result LOINC Value
616052 HIV-1 Genotypic Drug Resistance, P 80689-3
616729 HIV-1 group M subtype 100984-4
616737 Nucleos(t)ide RT mutations 45175-7
616918 Reverse Transcriptase failed codons 100983-6
616738 Abacavir 30287-7
616739 Didanosine 30284-4
616740 Emtricitabine 41402-9
616741 Lamivudine 30283-6
616742 Stavudine 30286-9
616743 Tenofovir 41396-3
616744 Zidovudine 30282-8
616745 Nonnucleoside RT mutations 45176-5
616746 Doravirine 91897-9
616747 Efavirenz 30291-9
616748 Etravirine 52749-9
616749 Nevirapine 30289-3
616750 Rilpivirine 68463-9
616751 Protease Mutations 33630-5
616919 Protease failed codons 100985-1
616752 Atazanavir + Ritonavir 49618-2
616753 Darunavir + Ritonavir 49630-7
616754 Fosamprenavir + Ritonavir 51409-1
616755 Indinavir + Ritonavir 49619-0
616756 Lopinavir + Ritonavir 42000-0
616757 Nelfinavir 30294-3
616758 Saquinavir + Ritonavir 49621-6
616759 Tipranavir + Ritonavir 49622-4
616760 Integrase mutations 61199-6
616920 Integrase failed codons 100986-9
616761 Bictegravir 90080-3
616762 Cabotegravir 96566-5
616763 Dolutegravir 72857-6
616764 Elvitegravir 72526-7
616765 Raltegravir 72525-9
HIRVL HIV RNA level copies/mL <30 days = 89543-3

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T732) with the specimen.