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Test Code HIVDR HIV-1 Genotypic Drug Resistance to Reverse Transcriptase, Protease, and Integrase Inhibitors, Plasma

Important Note

This test is only orderable by the laboratory.  To request this test in EPIC, please order LAB001 MAYO MISCELLANEOUS TEST.  Fill out appropriate prompts and request the Mayo test code listed above.

If you need further assistance, please contact the laboratory at 406-414-5010.


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)

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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

Forms

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

Testing Algorithm

For information see HIV Treatment Monitoring Algorithm

Special Instructions