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

FEATURE

SPECIFICATION

Number of tests1/5/20
PrincipleLateral Flow Chromatographic Immunoassay
Assay formatQualitative
Time to Results15
Sample typeNasal Swab Specimen
StorageRoom Temperature
CertificationTFDA / 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): 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%)

PositiveNegative
Positive592
Negative273
Total6175

ORDERING INFORMATION

Catalogue No.Product
4LCO019CGB COVID-19 Ag Rapid Test – 20T
4LCO01ECGB COVID-19 Ag Rapid Test – 5T
4LCO01AEGB COVID-19 Ag Rapid Test – 1T

GB COVID-19 Ag POCT (Professional)

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 tests20
PrincipleLateral Flow Chromatographic Immunoassay
Assay formatQualitative
Time to Results15
Sample typeNasopharyngeal Swab Specimen
StorageRoom Temperature
CertificationTFDA / 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%)

PositiveNegative
Positive796
Negative5317
Total84323

ORDERING INFORMATION

Catalogue No.Product
4LCO009EGB COVID-19 Ag POCT – 20T