Detect and quantify HIV-1 in CSF.
Quantitative Transcription-Mediated Amplification
Cerebral spinal fluid.
Transfer 2 mL CSF to an ARUP Standard Transport Tube and freeze. (Min: 0.8 mL)
Plasma (refer to Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma, ARUP test code 3000867).
Ambient: Unacceptable; Refrigerated: 5 days; Frozen: 1 month
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 re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
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".
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.
|Component Test Code*||Component Chart Name||LOINC|
|3000873||HIV-1 Qnt by NAAT, CSF (log copies/mL)||41497-9|
|3000971||HIV-1 Qnt by NAAT Interp, CSF||42917-5|
|3000995||HIV-1 Qnt by NAAT, CSF (copies/mL)||41498-7|
- HIV quantitative
- HIV-1 RNA
- HIV-1 RNA Viral Load
- HIV1 viral load monitoring
- Human Immunodeficiency Virus 1
- Nucleic Acid Amplification Test (NAAT)