Lab Test

HIV-1 RNA Qualitative by PCR

Human Immunodeficiency Virus 1 quantitation, HIV 1 RNA Qualitative by PCR

Test Codes

EPIC: LAB7097, Code: IHIVR

Department

Molecular Pathology

Specimen Collection Criteria

Collect: Plasma

Acceptable: Two Lavender-top EDTA tubes.

  • Preferred: 2mL; Minimum: 0.650 mL
  • Separate samples must be submitted when multiple tests are ordered.

Physician Office/Draw Specimen Preparation

Centrifuge to separate plasma from cells within 24 hours of collection.

Collect enough whole blood to allow for a minimum of 1 mL of plasma. Whole blood collected in EDTA tubes are stable for up to 24 hours at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to centrifugation.

After centrifugation, transfer all available plasma to a sterile plastic transport tube and refrigerate (2-8°C or 36-46°F). Plasma or serum samples may be stored refrigerated (2-8°C or 36-46°F) for up to 6 days.

Preparation for Courier Transport

Transport:

  • Uncentrifuged whole blood can be transported at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) if processed within 24 hours of collection.
  • Plasma, refrigerated (2-8°C or 36-46°F). Freezing plasma is no longer required if delivered to the lab within 6 days of collection.

Rejection Criteria

  • Specimens not centrifuged within 24 hours of collection.
  • Specimens collected in Green-top heparin tubes or White-top PPT tubes.
  • Specimens not maintained refrigerated or frozen following separation.
  • Specimens exposed to repeated freeze/thaw cycles.
  • Specimens with less than 0.650 mL plasma/serum.
  • Unlabeled tubes.

In-Lab Processing

Specimens must be centrifuged with plasma or serum separated from cells within 24 hours of collection. After centrifugation, please ensure that all available plasma or serum is transferred to a sterile plastic transport tube.

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 6 days – Centrifuged plasma only
Frozen (-20°C/-4°F or below): 12 weeks – Centrifuged plasma only

Specimen Storage in Department Prior to Disposal:

Frozen (-20°C/-4°F or below): 4 weeks

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

At least once per week.
Results available within 7-10 days.

Reference Range

HIV-1 RNA not detected. The analytical sensitivity is 13.2 copies/mL (plasma).

Reportable range is 20 - 10,000,000 copies/mL. Results exceeding 10,000,000 will not be diluted and will be reported as greater than 10,000,000 copies/mL.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)-Roche COBAS® 6800 HIV-1 Test (FDA Approved).

Clinical Utility

  • This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.
  • The lower limit of reporting in this assay is less than 20 copies/mL. A result reported as “detected” less than 20 copies/mL indicates the presence of HIV-1 RNA concentrations below the level of quantitation of the assay.
  • This test is NOT intended for use as a screening test for the presence of HIV-1 in donated blood or plasma or as a diagnostic test to confirm the presence of HIV-1 infection

CPT Codes

87535
LOINC: 5017-9

Contacts

Last Updated

10/3/2022

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