Reverse Transcription Polymerase Chain Reaction/Sequencing
HIV-1 Quantitative Range:
20 – 10,000,000 copies/mL
(1.3 - 7.0 log copies/mL)
A result of ‘Not Detected’ does not rule out the presence of PCR inhibitors or HIV-1 RNA concentrations below the level of detection by the assay.
HIV-1 Quantitative Specificity:
100% with a confidence limit of 99.6% (A total of 660 EDTA plasma samples tested).
HIV-1 Quantitative Analytical Specificity:
No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast.