| Number of tests | 20 |
| Principle | Lateral Flow Chromatographic Immunoassay |
| Assay format | Qualitative |
| Time to Results | 15 |
| Sample type | Nasopharyngeal Swab Specimen |
| Storage | Room Temperature |
| Certification | TFDA / CE |
The clinical performance of the GB COVID-19 Ag POCT was established with individual symptomatic patients who were suspected of COVID-19. The results are as follows:
| Positive | Negative | |
| Positive | 79 | 6 |
| Negative | 5 | 317 |
| Total | 84 | 323 |
Positive percent agreement (PPA): 94.05% (95% CI: 86.65% - 98.04%)
Negative percent agreement (NPA): 98.14% (95% CI: 96.00% - 99.32%)
Accuracy: 97.30% (95% CI: 95.22% - 98.64%)
| Catalogue No. | Product |
| 4LCO009E | GB COVID-19 Ag POCT - 20T |