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AccessBio CareStart COVID-19 Antigen Test

 
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The CareStart™ COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings. The CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests.

This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. 

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INSTANT USE KITS

Rapid results in 10 minutes

  • Professional Use Only
  • Tests should be conducted by a medical professional with CLIA waiver
  • Verification of use case prior to shipping is mandatory

Download Details

AccessBio CareStart COVID-19 Antigen Test
Patient Fact Sheet
HCP Fact Sheet
EUA Letter

Questions?

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In accordance with FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, we are not selling tests to the general public at this time. Please review our Terms and Conditions & Privacy Policy at Checkout and confirm you are an eligible purchaser. All orders are being evaluated due to stricter FDA guidelines. If we deem your order is not for professional use then a refund will be given and your order will be cancelled. On 3/23/20, the FDA acknowledged receipt of the necessary intent to launch notices for this testing kit so it may be utilized under the FDA’s Emergency Use Authorization.  For additional information regarding the FDA’s EUA for In Vitro Diagnostic Products, please visit this link. This test’s EUA Submission Number is EUA200056.