MICHIGAN DEPARTMENT OF COMMUNITY HEALTH

BUREAU OF LABORATORIES

HIV-1 Viral Genotype Testing for Drug Resistance

Rev. 1/29/2015

HIV-1 Viral Genotype Testing for Drug Resistance

ANALYTES TESTED: HIV-1. For ADAP Clients only. See notes below.

USE OF TEST: In vitro nucleic acid amplification and sequence analysis test for

the determination of anti-resistance markers.

SPECIMEN COLLECTION AND SUBMISSION GUIDELINES:

Test Request Form DCH-0583

Specimen Submission Guidelines

Specimen Collection Instructions DCH-1187

Transport Temperature: Frozen. Ship on dry ice for next day delivery.

SPECIMEN TYPE:

Specimen Required: EDTA plasma.All instructions MUST be followed for the collection and submission of specimens. See reverse of FORM DCH-1187, Instructions for Collection and Submission of Specimens for HIV-1 Genotyping.

Minimum Acceptable Volume: Fill the EDTA specimen tube to the intended fill volume, as partially filled collection tubes will result in erroneous results due to excessive dilution of plasma. Minimum volume of 2.5 ml plasma is necessary for testing. (A second EDTA specimen tube must be collected for viral load testing. Minimum volume required for Viral Load testing is 2.0 ml EDTA plasma.)

Container:Polypropylene tube.

Shipping Unit: Unit 19

SPECIMEN REJECTION CRITERIA:

Critical Data Needed For Testing: patient identifier, current HIV-1 viral load.

TEST PERFORMED:

Methodology: Polymerase Chain Reaction (PCR) and sequencing.

Turn Around Time: 1-2 months.

Where/When Performed:Lansing, monthly.

RESULT INTERPRETATION:

Reference Range: Susceptible

Reported as susceptible, possible resistance, resistant, or insufficient evidence to commonly used nucleoside and nucleotide RT inhibitors, nonnucleoside RT inhibitors, and protease inhibitors.

FEES:N/A

NOTES:

  1. HIV-1 Genotype Testing is available to “ADAP Approved Programs Only.”
  2. Viral load testing must be performed no longer than 21 days prior to HIV-1 genotype testing.
  3. This assay will only be run if the HIV-1 viral load is greater than 2000 copies/mL.
  4. Specimens must be collected and submitted according to instructions.
  5. Specimen must be shipped by the quickest method possible. Next day delivery is required.
  6. Reliable results are dependent on adequate specimen collection, transport, and storage of specimen.
  7. For use with HIV-1 subtype B.
  8. This assay predicts HIV-1 resistance to Protease and Reverse Transcriptase inhibitor anti-retroviral drugs. The entire Protease gene and approximately two-thirds of the Reverse Transcriptase gene of the viral genome are sequenced.

ALIASES: HIV, HIV-1, Drug Resistance, Genotype, HIV genotype