Flowflex™ COVID-19 Antigen Home 5 Tests Pack FDA EUA OTC



Flowflex™ COVID-19 Antigen Home Tests Specification

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

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Flowflex™ COVID-19 Antigen Home 5 Tests Pack FDA EUA OTC

The US Food and Drug Administration has granted an Emergency Use Authorization to an over the counter (OTC) COVID-19 test that agency officials say will double at-home testing capacity.

SARS-CoV-2 Antigen tests play a critical role in the fight against COVID-19. There is emerging thinking that self-testing options could potentially support the COVID-19 response by reducing community spread, when linked to appropriate responses for isolation, contract tracing and care. In addition, modelling shows that if self-testing is performed frequently, and if patients are compliant with countermeasures, it could have a greater impact on transmission than one-time testing using more sensitive but slower laboratory-based diagnostics.

The inability to find at-home tests has led to people driving from store to store, monitoring online sellers, and trading tips with others. It’s also suspected, at least in part, of contributing to long lines at testing sites throughout the US.

The Flowflex test only needs to be taken once if a person is symptomatic, according to the FDA. Other tests need to be taken twice, with days between them, in case the amount of viral protein does not meet the detection threshold of the first test.


  • 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%)*

Test Procedure

Flowflex COVID-19 Antigen Home Test -