Flowflex SARS-CoV-2

Antigen Rapid Test (Nasal/Saliva)

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

Product is Available for International Distribution Only – Not Available in the US

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

Product Features

The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and saliva 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 can also test specimens from asymptomatic individuals.

Performance

 

Relative Sensitivity:

Nasal Swab: 97.1% (95% CI: 93.1%-98.9%) 95% Confidence Intervals
Saliva: 91.4% (95% CI: 84.3%-95.6%) 95% Confidence Intervals

Relative Specificity:

Nasal Swab: 99.5% (95% CI: 98.2%-99.9%) 95% Confidence Intervals
Saliva: 99.6% (95% CI: 97.4%-99.9%) 95% Confidence Intervals 

Accuracy:

Nasal Swab: 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
Saliva: 97.1% (95% CI: 94.6%-98.5%) 95% Confidence Intervals

 

Test Highlights

  • Nasal swab and Saliva specimens
  • Results in 15 minutes
  • Excellent performance compared to molecular methods
  • Room temperature storage

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

Operating Instructions

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

Product Specifications

Feature Specification
Test Format Cassette
Specimen Format Nasal Swab and Saliva
Detects The nucleocapsid protein antigen from SARS-CoV-2 
Sample Volume 4 to 5 drops of the prepared specimen
Relative Sensitivity

Nasal Swab: 97.1% (95% CI: 93.1%-98.9%) 95% Confidence Intervals
Saliva: 91.4% (95% CI: 84.3%-95.6%) 95% Confidence Intervals

Relative Specificity Nasal Swab: 99.5% (95% CI: 98.2%-99.9%) 95% Confidence Intervals
Saliva: 99.6% (95% CI: 97.4%-99.9%) 95% Confidence Intervals
Accuracy Nasal Swab: 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
Saliva: 97.1% (95% CI: 94.6%-98.5%) 95% Confidence Intervals
Test Time 15 minutes
Shelf Life 24 Months
Store Temperature 2 – 30 °C

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