Access Bio's CARESTART COVID-19 Antigen Rapid Test

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.

• Lateral flow assay
• Rapid results in 10 minutes
• Nasopharyngeal swab specimen collection
• Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver*, Certificate of Compliance, or Certificate of Accreditation
• Detect SARS-CoV-2 nucleocapsid protein antigen
• Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
• Designated as a CLIA waived tests

All Point of Care customers are REQUIRED to have a CLIA Certificate of Waiver or a CLIA Authorized Laboratory Number to administer this Covid-19 Rapid Test in their facility. You must include the name of the test (Access Bio CareStart COVID-19 Antigen test) on your CMS application to ensure speedy processing.

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.

Kit Includes

• 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

Resources

• CareStart COVID-19 Antigen Flier
• CareStart COVID-19 EAU Instructions Package Stuffer
• CLIA Waver Application form #CMS-116
• State Agency Listing for CLIA Submission
• NY State Guidance for CLIA Application Procedure
• FDA EUA Info for In Vitro Diagnostics
• AccessBio Website




NOTICE - All Sales are Final due to Pandemic Related Allocation Policies. Completion of sale requires all buying entities self-certify CLIA status prior to shipping.