Table 2.
Abbott Alinity m SARS-CoV-2 Assay Analytical Sensitivity.
| Analytical Sensitivity | Virus Copies/mL | Replicates | % Positive | Mean CN | Instrument |
| Initial | 1000 | 3 | 100% | 32.11 | Alinity m #1 |
| 200 | 3 | 100% | 34.77 | ||
| 100 | 3 | 100% | 35.36 | ||
| 50 | 3 | 100% | 37.11 | ||
| 25 | 3 | 100% | 38.71 | ||
| Confirmatory | |||||
| 100 | 20 | 100% | 35.80 | ||
| 50 | 20 | 100% | 36.91 | ||
| Initial | 1000 | 3 | 100% | 33.08 | Alinity m #2 |
| 200 | 3 | 100% | 35.40 | ||
| 100 | 3 | 100% | 35.82 | ||
| 50 | 3 | 100% | 37.11 | ||
| 25 | 3 | 67% | 38.17 | ||
| Confirmatory | 100 | 20 | 100% | 36.38 | |
| 50 | 20 | 100% | 37.12 | ||
| 25* | 20 | 60% | 39.18 |
Abbreviations: CN, cycle number.
*The twenty replicates for confirmatory sensitivity at 25 virus copies/mL was run only on a single Alinity m instrument due to reagent/consumable constrictions. Notably, the congruency between both instruments is adequate. The limit of detection for both Alinity m instruments with an observed positivity rate >95% was confirmed at 50 virus copies/mL using SeraCare RNA standards. Confirmatory line-item CN data is described in Supplemental Data 2.