The CareStart COVID-19 Antigen Covid-19 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.
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.
The CareStart Antigen test covers proteins of variants such as B.1.1.7 (Alpha), B.1.351 (Beta), B.1.1.248 (Gamma), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, AY.1 (Delta plus), C.37 (Lambda).
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