In Vitro Diagnostics (IVD)

ELISA Immunoassay Chemiluminescence Immunoassay Molecular Diagnostics Point of Care Testing Cell Diagnostics

GB COVID-19 Ag Rapid Test (Self-testing)

A lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs specimens directly from individuals who are suspected of COVID-19.

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FEATURE

Easy to perform, no equipment required
Fast results
High accuracy

SPECIFICATION

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

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	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%)

ORDERING INFORMATION

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