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Rapid COVID Test

Features

Clinical Features
  • 20 tests per box
  • Lateral flow assay
  • Rapid results in 10 minutes
  • Minimally invasive specimen collection (nasopharyngeal)
  • Intended at POC setting (i.e., in patient care settings) by medical professionals
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Identify acute infection with high sensitivity and 100% specificity
Not for Home Use
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 The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen,, not for any other viruses or pathogens; this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner
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Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.



About Test

Test results are interpreted at 10 minutes. The presence of two colored lines in the control line region "C" and test line region "T" indicates COVID-19 positive. The presence of one colored line in the control line region "C" indicates COVID-19 negative. No appearance of a color line in the control region "C" indicates an invalid test.

Reagents and Materials Provided

Contents Name

Quanity
(in a kit)

Description
Test device 20 each Foil pouched test device containing one test strip encased in plastic device cassette.
Extraction vial/cap 20 vials and caps The extraction vial contains 400 μL extraction buffer solution . (2 bags x 10 vials/caps)
Nasopharyngeal swab 20 each Swabs for nasopharyngeal specimen collection
Positive control swab 1 each Recombinant SARS-CoV-2 nucleocapsid protein antigen dried on foam-tipped head.
Negative control swab 1 each Blank Universal Viral Transport media (BD UTM) dried on foam-tipped head.
Package Insert 1 each Instruction for use
Quick Reference Instructions (QRI) 1 each Quick Reference Instructions
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