Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification

Figure 2

Linear range of the HIV-1 RNA-based Amplix real-time PCR assay. Viral HIV-1 RNA levels were measured in HIV-seronegative plasma samples that were spiked with HIV-1 group M subtype B viral stock (at 10,001,789 copies/mL) at final concentrations of 25, 50, 100, 500, 5000, 100,000, 500,000, 2,000,000, 5,000,000, and 10,000,000 copies/mL. Slope and Y-intercept values for the resultant trend line were 0.980 (95% CI, [0.934–1.026]) and 0.253, respectively, as determined by unweighted linear regression ( = 0.981). Each sample was assayed in duplicate. The diagonal dotted line represents the ideal line (no bias). The full line represents the regression line of the distribution ().