ACCESS BIO

CareStart™ COVID-19 Antigen

US-made intended point-of-care (POC) test with results in minutes

The Access Bio, Inc. 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 anterior nares swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.

As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.

CareStart Antigen Test
  • Rapid results within 10 minutes
  • No lab equipment or additional instrument required
  • Anterior nares swab specimen collection
  • Detects SARS-CoV-2 nucleocapsid protein antigen via a lateral flow assay
  • Designated as a CLIA waived test
  • Manufactured in the U.S. by a U.S. headquartered company
    • 20 Test devices
    • 20 Assay buffer
    • 20 Extraction vials and caps
    • 20 Specimen collection swabs
    • 1 Positive and 1 negative control swabs
    • 1 Instructions for Use

The CareStart™ 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 operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. 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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