Flowflex SARS-CoV-2

Antigen Rapid Test Strip (Nasal/Nasopharyngeal)

ACON Laboratories, Inc
SARS-CoV-2 Antigen Rapid Test

Flowflex SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)

Product Features

The SARS-CoV-2 Antigen Rapid Test Strip is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test Strip can also test specimens from asymptomatic individuals.

Performance

 

Relative Sensitivity:

Nasal Swab: 97.4% (95% CI: 92.3%-99.5%)
Nasopharyngeal Swab: 97.4% (95% CI: 92.3%-99.5%)

Relative Specificity:

Nasal Swab: 99.8% (95% CI: 98.5%-100.0%)
Nasopharyngeal Swab: 99.8% (95% CI: 98.5%-100.0%

Accuracy:

Nasal Swab: 99.2% (95% CI: 98.0%-99.8%
Nasopharyngeal Swab: 99.2% (95% CI: 98.0%-99.8%)

 

Test Highlights

  • Nasal and Nasopharyngeal swab specimens

  • Results in 15 minutes

  • Excellent performance compared to molecular methods

  • Room temperature storage

Flowflex SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)

Operating Instructions

Flowflex SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)

Product Specifications

Feature Specification
Test Format Strip
Specimen Format Nasal swab specimens and Nasopharyngeal swab specimens
Detects The nucleocapsid protein antigen from SARS-CoV-2 
Relative Sensitivity Nasal Swab: 97.4% (95% CI: 92.3%-99.5%)
Nasopharyngeal Swab: 97.4% (95% CI: 92.3%-99.5%)
Relative Specificity Nasal Swab: 99.8% (95% CI: 98.5%-100.0%)
Nasopharyngeal Swab: 99.8% (95% CI: 98.5%-100.0%)
Accuracy Nasal Swab: 99.2% (95% CI: 98.0%-99.8%
Nasopharyngeal Swab: 99.2% (95% CI: 98.0%-99.8%)
Test Time 15 minutes
Shelf Life 24 Months
Store Temperature 2 – 30 °C

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