CareStartTM COVID-19 Antigen

Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen

CareStart™ COVID-19 Antigen Rapid Point-of-Care Test*

The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.

As an intended point-of-care (POC)* designated test with results to be read at 10 minutes, CareStart™ COVID-19 Antigen Test allows diagnostic indication of COVID-19 by qualified healthcare professionals on a large scale.

  • Rapid results in 10 minutes
  • Stand-alone test kit with no equipment needed
  • Designed for use in point-of-care settings with a CLIA certificate of waiver
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Lateral flow assay
  • Minimally invasive specimen collection (nasopharyngeal or anterior nasal)
Emergency Use Authorization by the FDA

* This test is authorized for point-of-care use by users with a CLIA certificate of wavier.

Access Bio CareStart COVID-19 Rapid Antigen Test

  • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;

  • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and

  • The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Procedure

 Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times

 Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.

 Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.

 Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.

Results Interpretation

Covid-19 Positive

Covid-19 Negative

Covid-19 Negative

Invalid

Product Documentation

Fact sheet for Healthcare providers
ifu (Instructions for use)
Fact sheet for patients
FDA Emergency use Authorization

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