Table 3.
Geometric mean values of 50% and 95% LODs (and 95% confidence intervals (CIs)) and geometric mean values of sensitivity factors of Cobas MPX relative to Ultrio Elite (and 95% CI) calculated from parallel line probit analysis results on 51 two-fold SANBS plasma dilution panels tested in 12 replicates per dilution (individual data presented in supplemental tables 2,3 and 4).
| In-house plasma dilution panel § | Number of panels tested | MPX 50% LOD (95% CI) | MPX 95% LOD (95% CI) | Elite 50% LOD (95% CI) | Elite 95% LOD (95% CI) | Relative sensitivity MPX/Elite (CI) | Range of Relative sensitivity MPX/Elite |
|---|---|---|---|---|---|---|---|
| HIV-1 RNA | 24 | 2.4 (1.0–4.1) | 12.5 (7.0–36) | 3.4 (1.7–3.4) | 17.9 (10.4–56) | 1.42 (0.68–3.87) | 0.26–2.72 |
| HBV DNA | 23 | 1.1 (0.3–3.9) | 6.1 (3.6–11.4) | 3.4 (2.1–5.1) | 19.5 (11.8–49) | 3.20 (1.54–11.6) | 1.26–6.50 |
| HCV RNA | 4 | 5.1 (2.4–9.0) | 29.3 (15.4–133) | 4.4 (2.0–8.0) | 25.6 (13.5–112) | 0.87 (0.34–2.10) | 0.75–0.98 |
two-fold dilutions were prepared of 15 NAT yield samples with viral load quantified by Abbott RealTime assay or by probit analysis against BioQControl standards. In addition, 4–9 concordant serology and NAT positive samples were pre-diluted to 300 cp/mL for preparation 2-fold dilutions. Viral loads of NAT yield samples varied between 3.3 cp/mL and 295 cp/mL for HIV-1 and ranged from 18 to 267 cp/mL for HBV. (See supplemental tables 1, 2 and 3).