CareStart™ Additional Information
Benefits
- 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
Test Principles
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 symptomatic individuals who are suspected of COVID-19 by their healthcare providers.
Procedure and Results Interpretation
FDA EMERGENCY USE AUTHORIZATION (Revised EUA 3/21)
Fact Sheet for Healthcare Providers
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.
The CareStart™ COVID-19 Antigen test is manufactured by Access Bio Inc. for Intrivo. CareStart™ is a trademark of Access Bio, Inc.