Shipped September 13, 2021
Expected results: COV2109-1: Negative COV2109-2: Positive COV2109-3: Positive COV2109-4: Positive
Participant’s results – All methods
| Reported | COV2109-1 | COV2109-2 | COV2109-3 | COV2109-4 |
|---|---|---|---|---|
| Positive | 2 (Unacceptable) | 29 (Acceptable) | 44 (Acceptable) | 42 (Acceptable) |
| Negative | 42 (Acceptable) | 14 (Unacceptable) | 1 (Unacceptable) | 2 (Unacceptable) |
| Inconclusive | 1 (Unacceptable) | 2 (Unacceptable) | 1 (Unacceptable) | |
| Total | 45 | 45 | 45 | 45 |
Participant’s results – Antigen methods
| Reported | COV2109-1 | COV2109-2 | COV2109-3 | COV2109-4 |
|---|---|---|---|---|
| Positive | 10 (Acceptable) | 21 (Acceptable) | 20 (Acceptable) | |
| Negative | 22 (Acceptable) | 12 (Unacceptable) | 1 (Unacceptable) | 2 (Unacceptable) |
| Total | 22 | 22 | 22 | 22 |
Participant’s results – Nucleic acid methods
| Reported | COV2109-1 | COV2109-2 | COV2109-3 | COV2109-4 |
|---|---|---|---|---|
| Positive | 2 (Unacceptable) | 19 (Acceptable) | 23 (Acceptable) | 22 (Acceptable) |
| Negative | 20 (Acceptable) | 2 (Unacceptable) | ||
| Inconclusive | 1 (Unacceptable) | 2 (Unacceptable) | 1 (Unacceptable) | |
| Total | 23 | 23 | 23 | 23 |
CMPT QA/QC: Samples were prepared at CMPT; samples were tested for homogeneity and stability after the day of production. Samples were stable for 15 days at room temperature.
ISO17043