Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

$500.00 $600.00

SKU: FLOWFLEX2

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Product Features

 

The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms.


Performance


Relative Sensitivity: 97.1% (95% CI: 93.1%-98.9%)*
Relative Specificity: 99.5% (95% CI: 98.2%-99.9%)*
Accuracy: 98.8% (95% CI: 97.6%-99.5%)*
*95% Confidence Intervals


Test Highlights


Results in 15 minutes
Nasal swab specimens
Room temperature storage
Excellent performance compared to molecular methods
24 months at 2-30°C


Flowflex™️ SARS-CoV-2 Antigen Rapid Test (Self-Testing)



Operating Instructions

Flowflex™️ SARS-CoV-2 Antigen Rapid Test (Self-Testing)

  • Product Specifications
  • Feature Specification
  • Test Format Cassette
  • Specimen Format Anterior nasal swab specimens
  • Detects The nucleocapsid protein antigen from SARS-CoV-2
  • Sample Volume 4 drops of the prepared specimen
  • Relative Sensitivity 97.1% (95% CI: 93.1%-98.9%) 95% Confidence Intervals
  • Relative Specificity 99.5% (95% CI: 98.2%-99.9%) 95% Confidence Intervals
  • Accuracy 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
  • Test Time 15 minutes
  • Shelf Life 24 Months
  • Store Temperature 2 – 30 °C

 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2#Individual%20EUAs

Emergency Use Authorization ACONlab Flowflex Ag Letter of Authorizations