TABLE 7.
AxSYM Combo p24 antigen analytical sensitivitya
| VIH SFTS96′ panel member | HIV-1 p24 concn (pg/ml) | S/CO for:
|
||
|---|---|---|---|---|
| Clinical reagent lot 1 | Clinical reagent lot 2 | Clinical reagent lot 3 | ||
| S2023 | 500 | 14.85 | 16.70 | 14.54 |
| S2024 | 250 | 8.95 | 9.43 | 7.00 |
| S2025 | 100 | 3.91 | 4.15 | 3.22 |
| S2026 | 50 | 2.23 | 2.30 | 1.64 |
| S2027 | 25 | 1.35 | 1.45 | 1.16 |
| S2028 | 10 | 0.73 | 0.79 | 0.71 |
| S2029 | 5 | 0.55 | 0.65 | 0.57 |
a
Sensitivity values 16.7, 14.5, and 21.2 pg/ml for clinical reagent lots 1 through 3, respectively, were derived from linear regression analysis of panel members S2025 to S2029 in a plot of S/CO versus p24 concentration at the point where S/CO is equal to 1. Correlation coefficients (R2) for linear regression analysis were 0.9987 for clinical reagent for lot 1, 0.9993 for clinical reagent lot 2, and 0.9935 for clinical reagent lot 3.