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HIV-1 Qualitative Assay by NAAT (LAB002043)
Test Mnemonic:


Specimen Requirements:

Serum Tubes

Serum Separator Tubes (SST)


Serum Tubes

Serum Separator Tubes

Minimum Volume:

Original Tube- 2mL of serum

13 x 100 Specimen Aliquot Tube- 1.5mL of serum


Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 90 days.

Specimen Preparation:

Within 24 hours of collection, centrifuge.


Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 90 days.

Causes for Rejection:

Improper collection. Specimen container unlabeled or labeled incorrectly. No date and time of collection or collector information on order.

Reference Range:

HIV-1 Not Detected

HIV-1 Detected

Turnaround Time:

5 days


Qualitative Transcription-Mediated Amplification.




HIV-1 Qualitative Test by NAAT, Human Immunodeficiency Virus, HIV-1 Qual, HIV-1 RNA, HIV-1 QL NAAT

Clinical Indication:

Detection of HIV-1 in serum specimens.

Patient Preparation :

Routine venipuncture for blood.

CPT 4 Code:



This test detects human immunodeficiency virus type 1 (HIV-1) RNA from Group M, N, and O subtypes. 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 solely on a single HIV-1 test result. Diagnosis requires repeat and confirmatory testing as recommended by the U.S. Health and Human Services Guidelines. Improper specimen handling can cause false negatives or contamination.

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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