Human Immunodeficiency Virus 1 (HIV-1) by Quantitative NAAT, Plasma

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 reentry protocols, or for screening human cell, tissues and cellular tissue-based products (HCT/P).

Note: 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."

Specimens received with less than minimum volume for testing will automatically be run with a dilution according to the guidelines below:
Specimens with 240-700 uL will be diluted resulting in a modification of the quantitative range of the assay to 1.95-7.48 log copies/mL (90-30,000,000 copies/mL).

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.