MICHIGAN DEPARTMENT OF COMMUNITY HEALTH

BUREAU OF LABORATORIES

HIV-1 Viral Load Testing (Quantitation of HIV-1 RNA in Human Plasma)

Rev. 1/30/2015

HIV-1 Viral Load Testing (Quantitation of HIV-1 RNA in Human Plasma)

ANALYTES TESTED: HIV-1 RNA in human plasma

USE OF TEST: In vitro nucleic acid amplification test for the quantitation of HIV-1 RNA in human plasma.

SPECIMEN COLLECTION AND SUBMISSION GUIDELINES:

Test Request Form DCH-0583 (DCH-0583 fillable)

Specimen Submission Guidelines

Transport Temperature: Frozen EDTA plasma

SPECIMEN TYPE:

Specimen Required: EDTA plasma, all instructions (located on the back of form DCH-0562) MUST be followed for the collection and submission of specimen.

Minimum Acceptable Volume: 2 ml plasma is necessary for testing

Container: Use polypropylene skirted-capped tube provided.

Shipping Unit: Unit 13

SPECIMEN REJECTION CRITERIA:

Critical Data Needed For Testing: Patient identifier, date of collection, ADAP #

TEST PERFORMED:

Methodology: In vitro nucleic acid amplification test for the quantitation of

HIV-1 RNA in human plasma.

Turn Around Time: Five-ten business days

Where/When Performed: Lansing. As necessary/At least weekly.

RESULT INTERPRETATION:

Reference Range: HIV-1 RNA Not Detected

FEES: N/A

NOTES:

  1. HIV-1 Viral Load Testing is available to "Approved Programs Only."
  2. Specimens must be collected and submitted according to instructions.
  3. Plasma must be sent by the quickest method possible. Next day delivery is recommended.
  1. Reliable results are dependent on adequate specimen collection, transport, and storage of specimen as per reverse of form DCH-0583.
  1. The lower limit of detection is 20 copies/ml.
  2. Quantitative range per manufacturer of 20 – 10,000,000 copies/mL.
  3. Tested using the COBAS® AmpliPrep/ COBAS® TaqMan® HIV-1 Test v.2.0 for Viral Load Testing. For use with HIV-1 Groups M and O. Has not been evaluated for HIV-2 or HIV-1 Group N.
  1. For comparison of results, all testing must be done with the COBAS® AmpliPrep/ COBAS® TaqMan® HIV-1 Test v.2.0 for HIV-1 Viral Load Testing.

ALIASES: HIV-1Viral Load