Ordering Recommendation

Detect and quantify HIV-1.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), yellow (ACD), or plasma preparation tube (PPT).

Specimen Preparation

Separate from cells within 24 hours of collection. Transfer 2 mL plasma to an ARUP standard transport tube and freeze. (Min: 0.8 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Serum. CSF (refer to Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, CSF, ARUP test code 3000872). Heparinized specimens.

Remarks
Stability

After separation from cells: Ambient: 24 hours (Critical: Ship FROZEN); Refrigerated: 72 hours; Frozen: 3 months

Methodology

Quantitative Transcription-Mediated Amplification (TMA)

Performed

Sun-Sat

Reported

1-4 days

Reference Interval

Not detected.

Interpretive Data

Normal range for this assay is "Not Detected."
The quantitative range of this assay is 1.47-7.00 log copies/mL (30-10,000,000 copies/mL).

An interpretation of "Not Detected" does not rule out the presence of inhibitors or HIV-1 RNA concentration below the level of detection of the assay. Care should be taken in the interpretation of any single viral load determination.
The clinical significance of changes in HIV-1 RNA concentration has not been fully established; however, a change of 0.5 log copies/mL may be significant.

This assay should not be used for blood donor screening, associated reentry protocols, or for screening human cell, tissues and cellular tissue-based products (HCT/P).

Note: The limit of quantification for this RNA assay is 1.47 log copies/mL (30 copies/mL). If the assay DETECTED the presence of the virus but was not able to accurately quantify the viral load, the test result will be reported as "<; 30 Detected."

Specimens received with less than minimum volume for testing will automatically be run with a dilution according to the guidelines below:
Specimens with 240-700 uL will be diluted resulting in a modification of the quantitative range of the assay to 1.95-7.48 log copies/mL (90-30,000,000 copies/mL).

This test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. This test is also used as an aid in assessing viral response to antiretroviral treatment as measured by changes in HIV-1 RNA concentration.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

87536

Components

Component Test Code* Component Chart Name LOINC
3000868 HIV-1 Qnt by NAAT (copies/mL) 20447-9
3000869 HIV-1 Qnt by NAAT (log copies/mL) 29541-0
3000970 HIV-1 Qnt by NAAT Interp 25835-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HIV quantitative
  • HIV-1 RNA
  • HIV-1 RNA Viral Load
  • HIV1 viral load monitoring
  • Human Immunodeficiency Virus 1
  • Nucleic Acid Amplification Test (NAAT)
Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma