Ordering Recommendation

Use to detect HIV-1 RNA qualitatively. For quantitative detection, refer to Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma (3000867).

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

Heparinized specimens.

Remarks
Stability

After separation from cells: Ambient: 24 hours (Critical: Ship FROZEN); Refrigerated: 72 hours; Frozen: 90 days

Methodology

Qualitative Transcription-Mediated Amplification (TMA)

Performed

Sun-Sat

Reported

1-4 days

Reference Interval

Not detected

Interpretive Data

This test detects human immunodeficiency virus type 1 (HIV-1) RNA from Group M, N and O subtypes; it does not detect HIV-1 proviral DNA. A result of "Not Detected" does not rule out HIV-1 RNA concentrations below the limit of detection of the assay or the presence of inhibitors in the patient specimen. The diagnosis of HIV-1 infection should not be made based solely on a single HIV-1 test result. Diagnosis requires repeat and confirmatory testing as recommended by U.S. Health and Human Services guidelines. Improper specimen handling can cause false negatives or contamination.

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).

Compliance Category

FDA

Note

Assay detects HIV-1 virus RNA. Proviral DNA will not be detected.

Hotline History

N/A

CPT Codes

87535

Components

Component Test Code* Component Chart Name LOINC
3003761 HIV-1 Qualitative by NAAT 5017-9
* 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 1 RNA
  • HIV Qualitative
  • HIV1 detection
  • Nucleic Acid Amplification Test (NAAT)
Human Immunodeficiency Virus 1 (HIV-1) by Qualitative NAAT