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 a 10 minute processing time, CareStart COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

Due to the highly contagious nature and global health crises, 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 efectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. Particularly, the identi#cation of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus. As a n intended point-of-care (POC) designated test with a 10 min processing time, CareStart COVID-19 Antigen Test allows e”ective screening of COVID-19 infection 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 Detect SARS-CoV-2 nucleocapsid protein antigen Lateral flow assay Minimally invasive specimen collection (nasopharyngeal)

AMA CPT Codes

FDA EUA Letter

Package Insert

Fact Sheet for Healthcare Providers

• Rapid results in 10 minutes
• Stand-alone test kit with no equipment needed
• Designed for use in point-of-care settings
• Detect SARS-CoV-2 nucleocapsid protein antigen
• Lateral flow assay
• Minimally invasive specimen collection (nasopharyngeal)