Table 2:
Analytical Sensitivity of Ultrio Elite and cobas MPX as determined by parallel line probit analysis on 24 replicate tests per standard dilution
| BioQ reference panel § | Limit of detection (LOD) in copies/mL | ||||
|---|---|---|---|---|---|
| cobas MPX 50% LOD (95% CI) | Ultrio Elite 50% LOD (95% CI) | cobas MPX 95% LOD (95% CI) | Ultrio Elite 95% LOD (95% CI) | Sensitivity of MPX relative to Elite | |
| P0007 HBV Genotype A | 1.9 (1.3–2.7) | 5.0 (3.4–7.3) | 17.8 (10.9–33.9) | 47.9 (29.1–92.5) | 2.68 (1.50–5.40) |
| P0019 HCV Genotype 1 | 3.0 (2.3–3.8) | 1.9 (1.3–2.7) | 21.9 (15.3–34.6) | 13.8 (8.9–24.0) | 0.63 (0.38–0.98) |
| P0027 HIV-1 Group M subtype C^ | 1.7 (1.2–2.4) | 2.1 (1.5–2.9) | 8.3 (5.5–14.7) | 10.4 (6.9–18.2) | 1.24 (0.80–2.03) |
§
calibrated in cp/mL in bDNA 3.0 assay and in IU/mL against 1st and 2nd WHO standards with conversion factors of 5.33 cp/IU for S0011 HBV-DNA genotype A, 2.73 cp/IU for S0009 HCV genotype 1 and 0.58 for S0012 HIV-1 subtype B standard;
^
S0014 HIV-1 subtype C standard was calibrated in cp/mL against S0012 BioQ HIV-1 subtype B standard in Abbott RealTime assay.