Rapid Response Diagnostics - COVID-19 Antigen Rapid Test Cassette | 1 Test
The Rapid Response™ COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a non-laboratory setting with direct anterior nasal (nares) swab samples for:
Relative Sensitivity: 94.51% (95% CI*: 87.64% - 98.19%)*±
Relative Specificity: 99.39% (95% CI*: 97.81% - 99.93%)*±
Relative accuracy: 98.33% (95% CI*: 96.59% - 99.33% )*±
*Confidence Interval±
±Clinical study value from product insert.
Result interpretation
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Rapid Response Diagnostics - COVID-19 Antigen Rapid Test Cassette | 1 Test
The Rapid Response™ COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a non-laboratory setting with direct anterior nasal (nares) swab samples for:
Relative Sensitivity: 94.51% (95% CI*: 87.64% - 98.19%)*±
Relative Specificity: 99.39% (95% CI*: 97.81% - 99.93%)*±
Relative accuracy: 98.33% (95% CI*: 96.59% - 99.33% )*±
*Confidence Interval±
±Clinical study value from product insert.
Result interpretation
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Description
The Rapid Response™ COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a non-laboratory setting with direct anterior nasal (nares) swab samples for:
Relative Sensitivity: 94.51% (95% CI*: 87.64% - 98.19%)*±
Relative Specificity: 99.39% (95% CI*: 97.81% - 99.93%)*±
Relative accuracy: 98.33% (95% CI*: 96.59% - 99.33% )*±
*Confidence Interval±
±Clinical study value from product insert.
Result interpretation
