
Features |
Clinical Features |
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Not for Home Use Free Ground Shipping 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 |
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 |
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 |