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Taking Samples

COVID-19 TEST KITS

Quidel QuickVue® OTC Test

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​Features

  • This product has been authorized only for the detection of proteins from SARS-CoV-2

  • This product has not been FDA Cleared or approved, but is authorized by FDA under an EUA

  • Based on the interim results of a clinical study where the QuickVue At-Home OTC COVID-19 Test was compared to an FDA authorized molecular SARS-CoV-2 test, QuickVue At-Home OTC COVID-19 Test correctly identified 83.5% of positive specimens and 99.2% of negative specimens

Technical

  • Authorized for at home use

  • 83.5% test accuracy in positive cases

  • 10 minute results

  • Easy to use

Quidel QuickVue® SARS Antigen Test

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​Features

  • This product has been authorized only for the detection of proteins from SARS-CoV-2

  • This product has not been FDA Cleared or approved, but is authorized by FDA under an EUA

  • Based on the interim results of a clinical study, QuickVue SARS Antigen COVID-19 Test correctly identified 96.8% of positive specimens

Technical

  • 96.8% test accuracy in positive cases

  • 10 minute results

  • Rx Only for professional use

BinaxNOW™ OTC Test

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​Features

  • This product has been authorized only for the detection of proteins from SARS-CoV-2

  • This product has not been FDA Cleared or approved, but is authorized by FDA under an EUA

  • BinaxNow demonstrates overall performance of 84.6% positive agreement and 98.5% negative agreement

Technical

  • Authorized for at-home use

  • 84.6% test accuracy in positive cases

  • 15 minute results

  • Easy to use

BinaxNOW™ SARS Antigen Test

binaxnow_SARS.png
​Features

  • This product has been authorized only for the detection of proteins from SARS-CoV-2

  • This product has not been FDA Cleared or approved, but is authorized by FDA under an EUA

  • BinaxNow SARS Antigent Test demonstrates overall performance of 93.3% positive agreement and 99.9% negative agreement

Technical

  • 93.3% test accuracy

  • 15 minute results

  • Rx Only for professional use

CareStart™ SARS Antigen Test

  • Detect SARS-CoV-2 nucleocapsid protein antigen with ultra-high performance

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  • Identify acute infection with 88.4% sensitivity and 100% specificity

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  • Lateral flow assay

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  • No equipment required

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  • Rapid results within 10 minutes

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  • Minimal invasive specimen collection (nasopharyngeal swabs)

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  • POC setting (i.e. in-patient care settings) by medical professionals

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