Sign in →

Test ID BLOD1675 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.


Secondary ID

616052

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)

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

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

Sanford Laboratories - Sioux Falls/Rapid City Additional Information:

SANFORD LABORATORIES INTERFACE BUILD INFORMATION

 Result Code     Result Code Description   
 13563  HIV-1 Genotypic Drug, Resistance   
 26967  HIV-1 Group M Subtype
 19067  Nucleos(t)ide RT Mutations
 26968  Reverse Transcriptase Failed Codons   
 13565  Abacavir
 13566  Didanosine
 19068  Emtricitabine
 19069  Lamivudine
 13568  Stavudine
 13569  Tenofovir
 13570  Zidovudine
 19070  Nonnucleoside RT Mutations
 25160  Doravirine
 13571   Efavirenz
 13572  Etravirine
 13573  Nevirapine
 16449  Rilpivirine
 13574  Protease Mutations
 26969  Protease Failed Codons
 13576  Atazanavir with Ritonavir
 13577  Darunavir with Ritonavir
 13579  Fosamprenavir with Ritonavir
 13581  Indinavir with Ritonavir
 13582 Lopinavir with Ritonavir
 13583  Nelfinavir 
 13584   Saquinavir with Ritonavir
 13585  Tipranavir with Ritonavir
 25343  Integrase Mutations
 26970  Integrase Failed Codons
 25344  Bictegravir
 26643  Cabotegravir
 25345  Dolutegravir
 25346  Elvitegravir
 25347  Raltegravir 
 26971   HIV RNA Level Copies/mL < 30 Days