COVID-19 Rapid POC Antigen Test, Box of 20

CareStart are the only COVID-19 Antigen Rapid Tests made in the USA that are authorized by the FDA under an EUA for specified use.

The SARS-CoV-2 is a pandemic, coronavirus, COVID-19, as declared by the World Health Organizaiton (WHO).Accurate and quick testing is the single most important aspect of helping prevent the spread of the disease. Detecting the asymptomatic and clinical cases of the coronavirus are of equal importance.

The CareStartTM COVID-19 Antigen Test allows effective screening on a large scale. It is intended as a point-of-care (POC) designated test with a 10 minute testing point.

• 10 minute rapid test result
• Identify individual’s current infection status to COVID-19
• Fast and easy to use in Point-of-Care setting
• Qualitatively detect the SARS-CoV-2 nucleocapsid protein
• Use nasopharyngeal (NP) swab specimens
• No special equipment or training required
• All-in-one package including collection swabs
• High sensitivity (88.4%) and specificity (100%)
• 100% Negative result
• Authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
• Authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked.

How-to video

https://www.youtube.com/watch?v=XqbBcaQOL6Q&feature=youtu.be

The CareStart™ COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings. The CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization. CLIA waived tests.