GB COVID-19 Ag POCT (Professional)
A lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swabs specimens directly from individuals who are suspected of COVID-19 by their healthcare provider.
PRODUCT DESCRIPTION
The GB COVID-19 Ag POCT is a qualitative membrane-based lateral flow immunoassay technology based on the double antibody-sandwich method. Using this test allows for the rapid detection of nucleocapsid protein from the SARS-CoV-2 swab from patients who are suspected of COVID-19.
FEATURE
SPECIFICATION
| 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 |
PERFORMANCE
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 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%)
| Positive | Negative | |
|---|---|---|
| Positive | 79 | 6 |
| Negative | 5 | 317 |
| Total | 84 | 323 |
ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4LCO009E | GB COVID-19 Ag POCT – 20T |