| HIV-1 Quantitative Assay by NAAT (8000100182) | |
|---|---|
| Test Mnemonic: | HIV-1-NAAT |
| Specimen Requirements: | |
| Collection: | Plasma preparation tube (PPT) |
| Container: | Plasma preparation tube (PPT) |
| Minimum Volume: | Original Tube - 2 mL of plasma 13 x 100 Specimen Aliquot Tube - 1.5 mL of plasma |
| Storage/Transport: | Refrigerate (2-8ºC) up to 3 days; Samples should be frozen (-20ºC) and tested within 90 days. |
| Specimen Preparation: | Within 24 hours of collection, centrifuge. |
| Stability: | Refrigerate (2-8ºC) up to 3 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: 30 - 10,000,000 copies/mL |
| Turnaround Time: | 5 days |
| Methodology: | Nucleic acid amplification by transcription-mediated amplification, target capture, and dual kinetic assay. |
| Performed: | |
| Lab: | Clinical Microbiology |
| Synonyms: | HIV-1 Viral Load, HIV-1 Quantitative Test, Human Immunodeficiency Virus, HIV-1 Quant |
| Clinical Indication: | Detection of HIV-1 in plasma specimens. |
| Patient Preparation : | Routine venipuncture for blood. |
| CPT 4 Code: | 87536 |
| Note: |
The Aptima HIV-1 Quant assay is an FDA-approved nucleic acid amplification test (NAAT) for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals. It is intended for use as an aid in monitoring the effects of antiretroviral treatment. It is not approved for use as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
The quantitative range of this assay is 1.47 - 7.00 log copies/mL or 30 - 10,000,000 copies/mL.
An interpretation of "Not Detected" does not rule out the presence of inhibitors in the patient specimen of HIV-1 RNA concentration below the level of detection of the test. Care should be taken when interpreting any single viral load determination.
Detected, not Quantifiable: HIV-1 RNA detected, but at a level below 30 copies/mL (1.47 log copies/mL). HIV-1 RNA concentration is below the lower limit of quantitation of the assay.
Indeterminate: Error indicated in the generation of the result. Please submit a new specimen for repeat testing if clinically indicated. |
| 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. | |