Human Immunodeficiency Virus 1 (HIV-1) Qualitative by NAAT, Whole Blood

3001474
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Example Reports
Detected
Not Detected

Ordering Recommendation

Detect HIV-1 RNA.

Mnemonic

HIV QUAL

Methodology

Qualitative Transcription Mediated Amplification

Performed

Tue-Sat

Reported

2-5 days

New York DOH Approval Status

Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA) or Pink (K2EDTA).

Specimen Preparation

Transport 1 mL whole blood. (Min: 0.4 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

Ambient: Unacceptable; Refrigerated: 1 week; Frozen: 1 week

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 re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Modified FDA

Note

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

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
05/20/2019
X
N/A

CPT Codes

87535

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Components

Component Test Code* Component Chart Name LOINC
3001475 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) Qualitative by NAAT, Whole Blood