CareStart Covid-19 Rapid Diagnostic Antigen Test

The CareStart Covid-19 Rapid Diagnostic 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 Rapid Diagnostic Antigen Testhelps provide critical answers about active infections to patients and healthcare workers alike.

Features and Benefits

Lateral flow assay

No equipment required

Rapid results at 10 minutes

Minimally invasive specimen collection (nasopharyngeal swabs)

Detect SARS-CoV-2 nucleocapsid protein antigen with ultra high performance

Test is only authorized at this time for POC use by qualified healthcare professionals.

Test is only authorized for a diagnostic indication.

Clinical performance

93.75% Positive Percentage Agreement (PPA) and 99.32% Negative Percent Agreement (NPA) when used with with nasopharyngeal swab

87.18% Positive Percentage Agreement (PPA) and 99.32% Negative Percent Agreement (NPA) when used with with anterior swab

Notes:

Carestart COVID-19 Antigen Test

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and