HIV Viral Load Testing Notification
The purpose of this notification is to inform clients of an upcoming change to the HIV-1 RNA, Ultra Quantitative viral load (HIVUL) test report.
Currently, reports for specimens resulted as Not detected for HIV-1 contain the value <20 copies/mL in the HIV-1 RNA Quantitative result field, indicating a viral load below the assay limit of detection (LOD).
In order to meet certain state reporting requirements, specimens resulted as Not detected for HIV-1 will now contain the value 0 copies/mL in the HIV-1 RNA Quantitative result field.
Specimens determined to contain HIV-1 RNA will still be called Detected and the viral load will be reported in the HIV-1 RNA Quantitative result field. Specimens with very low viral loads between 1-19 copies/mL will continue to be reported as Detected with <20 copies/mL reported in the result field.
There is no change to the performance of the HIV-1 RNA assay. Results for all specimens prior to this change will remain unchanged. As indicated in the report messages, a Not detected result does not rule out infection.
Refrigerated: 3 days
Frozen (-20°C): 3 days
Frozen (-70°C): 6 weeks
(RT-PCR) assay for the detection and quantitation of the diverse group M subtypes A-H as well as
group O and N isolates.
The lower limit of quantitation is 20 copies/mL (1.30 log copies/mL) and the upper limit of
quantitation is 10,000,000 copies/mL (7.0 log copies/mL). The qualitative limit of detection is 20
copies/mL (1.30 log copies/mL). Specimens reported as DETECTED but <20 copies/mL contain
detectable levels of HIV-1 RNA even though the viral load is below the limit of quantitation.
HIV-1 RNA Quantitative: <20 copies/mL
LOG HIV CP U/mL: <1.3