Table 2.
Clinical performance of the different methodologies used for the detection of SARS-CoV-2 in Argentina.
| Kits | Target Genes 1 | Kappa Index (CI 95%) |
Clinical Sensitivity (%) (CI 95%) |
Clinical Specificity (%) (CI 95%) |
|---|---|---|---|---|
| Altona Diagnostics | E | 0.97 (0.85–1) | 100 (89.3–100) | 96.7 (0.79–0.98) |
| S | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (88.6–100) | |
| E + S | 1.00 (1.00–1.00) | 100 (89.3–100) | 100(88.6–100) | |
| DaAn Gene | N | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (88.6–100) |
| ORF1ab | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (88.6–100) | |
| N + ORF1ab | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (88.6–100) | |
| Bioneer | E | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) |
| RdRp | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) | |
| E + RdRp | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) | |
| VIASURE-CerTest | N | 1.00 (0.85–1.00) | 100 (89.0 –100) | 100 (79.3– 98.2) |
| ORF1ab | 0.42 (0.24–0.60) | 42 (26.4–59.2) | 100 (89.0–100) | |
| N + ORF1ab | 0.42 (0.24–0.60) | 42 (26.4–59.2) | 100 (89.0–100) | |
| GeneFinder | E | 0.97 (0.91–1.00) | 96.8 (83.8 –99.4) | 100 (89.0–100) |
| N | 1.00 (1.00–1.00) | 100 (89.0–100) | 100 (89.0–100) | |
| RdRp | 0.81 (0.66–0.95) | 80.6 (63.7–90.8) | 100 (89.0–100) | |
| E + N + RdRp | 1.00 (1.00–1.00) | 100 (89.0–100) | 100 (89.0–100) | |
| Anatolia | E | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) |
| ORF1ab | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) | |
| E + ORF1ab | 1.00 (1.00–1.00) | 100 (89.3–100) | 100 (89.0–100) | |
| ARGENE | N | 0.97 (0.91–1.00) | 100 (89.3–100) | 96.8 (83.8–99.4) |
| RdRp | 0.81 (0.67–0.95) | 81.3 (64.7–91.1) | 100 (89.0–100) | |
| E | Use for resolution of equivocal samples | |||
| N + RdRp + (E) | 1.00 (0.91–1.00) | 100 (89.3–100) | 100 (83.8–99.4) | |
| CoronArDx | E | 0.94 (0.69 –1.00) | 93.8(79.9–98.3) | 100 (88.6–100) |
| RdRp | 0.31 (0.13–0.48) | 31.3 (18.0–48.6) | 100 (88.6–100) | |
| E + RdRp | 0.94 (0.69–1.00) | 93.8 (79.9–98.3) | 100 (88.6–100) | |
| Wiener lab | N + RdRp | 0.97 (0.91–1.00) | 96.9 (84.3 –99.4) | 100 (89.0–100) |
| iAMP COVID-19 Detection Kit | N + ORF1ab | 0.93 (0.67–1.00) | 92.6 (83.0–100) | 100.0 (89.0–100) |
| NEOKIT | E + N + ORF1aa + ORF1ab | 0.75 (0.59–0.91) | 75.0 (57.9–86.7) | 100.0 (0.89–100) |
| ELA-CHEMSTRIP | E | 0.84 (0.71–0.97) | 100 (89.3–100) | 83.9 (67.4–92.9) |
1 SARS-CoV-2 targets: E gene, S gene, N gene, RdRp gene. ORF1ab: 0pen reading frame 1ab. CI95%: 95% confidence interval.