Products listed on our website may require specific CLIA certifications (waived or moderate to high complexity) which we will need to verify prior to shipping products that fall in these categories.
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 (NP) allows diagnostic testing on a large scale. It is intended as a point-of-care (POC) designated test with a 10 minute testing point.
• 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
Authorized for use only in-patient care settings operating under a CLIA Certificates of Waiver, Compliance, or Accreditation. This product can only be sold to healthcare facilities, practitioners, institutions, or qualified research or screening organizations. Testing is not for home use and is intended to be administered by a trained healthcare professional.
We will contact you to verify your healthcare provider credentials prior to shipping. Please do not order this product if you are not a licensed healthcare provider or laboratory as we will have to cancel your order.
This product has not been 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
The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C 360bbb3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
Test are only authorized for Point-of-Care use by qualified healthcare professionals.