SCoV-2 Ag Detect™ Rapid Test

US FDA 510(k) Cleared • CLIA Waived • Rx Only • CE Marked

Covid POC test
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The SCoV-2 Ag Detect™ Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.

See below for the full intended use statement.

Resources

The SCoV-2 Ag Detect™ Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the SCoV-2 Ag Detect™ Rapid Test and followed up with a molecular test.

A negative test result is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024.The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

  • Point of Care: CLIA Waived test can be performed in a variety of settings, from physician offices to school health clinics, with symptomatic individuals. Do not use for individuals who have no symptoms or have had symptoms longer than 4 days.

  • Sequence analysis performed at InBios suggests test will detect variants currently in circulation, including KP.3.1.1.

  • Identifies acute infection in symptomatic patients:

      • PPA (Relative Sensitivity): 84.2%
      • NPA (Relative Specificity): 99.8%

  • Unique patent pending design – no mixing step!

  • Quick visual results – no instrumentation needed.

  • 50 or 20 test packs available. Includes positive and negative controls.

  • Room temperature storage.

  • 100% manufactured in the USA.

Catalog No. COVAF-50 COVAF-20
Format ICT (cassette) ICT (cassette)
Quantity/Kit 50 20
Time to Result ~20 minutes ~20 minutes
Sample Type Direct nasal swabs Direct nasal swabs
Storage Room Temperature (15°C-30°C) Room Temperature (15°C-30°C)
Shelf Life 13 months 13 months

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For more information, download Instructions For Use under the “Downloads” tab.

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