| Number of tests | 1/5/20 |
| Principle | Lateral Flow Chromatographic Immunoassay |
| Assay format | Qualitative |
| Time to Results | 15 |
| Sample type | Nasal 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 | 59 | 2 |
| Negative | 2 | 73 |
| Total | 61 | 75 |
Positive percent agreement (PPA): 96.72% (95% CI: 88.65% - 99.60%)
Negative percent agreement (NPA): 97.33% (95% CI: 90.70% - 99.68%)
Accuracy: 97.06% (95% CI: 92.64% - 99.19%)
| Catalogue No. | Product |
| 4LCO019C | GB COVID-19 Ag Rapid Test - 20T |
| 4LCO01EC | GB COVID-19 Ag Rapid Test - 5T |
| 4LCO01AE | GB COVID-19 Ag Rapid Test - 1T |