In Vitro Diagnostics (IVD)

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

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.

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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

Easy to perform, no equipment required
Fast results
High accuracy

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	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%)

ORDERING INFORMATION

Catalogue No.	Product
4LCO009E	GB COVID-19 Ag POCT - 20T