Description
*This product is only available to purchase by licensed physicians, clinics and other authorized professionals and institutions. This product is not for home use.
**CLIA verification required for all purchases
Please email our Sales Team at [email protected] for pricing and order requirements
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 Organization (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 (AN) allows diagnostic testing on a large scale. It is intended as a point-of-care (POC) designated test with a 10 minute testing point.
Product Features:
• USA manufactured, lateral flow assay
• Rapid results in 10 minutes
• No equipment required
• Intended at POC setting by medical professionals
• 93.75% PPA* and 99.32% NPA** when used with nasopharyngeal swab
• 87.18% PPA* and 100% NPA** when used with anterior nasal swab
• Detect SARS-CoV-2 nucleocapsid protein antigen
*PPA Positive Percent Agreement
** NPA Negative Percent Agreement
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Warning
▪ This test has not been FDA cleared or approved;
▪ This test has been authorized by FDA under an EUA for use by authorized laboratories;
▪ This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
▪ This test is only 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 sooner.
▪ Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
▪ This product is intended for professional use and not for home use.
▪ Not for the screening of donated blood.
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