CareStart COVID-19 Antigen Rapid Diagnostic Test for the Detecting of SARS_CoV-2 Antigen 20 Test per Box
Due to FDA Guidelines and Supply Chain Demands All Orders for this Product are NON-Returnable.
Due to the highly contagious nature and global spread, 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.
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 in symptomatic patients on a large scale.
━ Lateral flow assay
━ Rapid results in 10 minutes
━ Nasopharyngeal specimen collection
━ Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver
━ Detect SARS-CoV-2 nucleocapsid protein antigen
━ Identify acute infection with 88.4% sensitivity and 100% specificity
━ Storage condition : 1-30 degrees Celsius
The CareStartTM COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen, 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.
The CareStart™ COVID-19 Antigen 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.
20 Test Devices:
20 Assay Buffer
20 Extraction Vials and Caps
20 Specimen Collection Swabs
1 Positive and 1 Negative Control Swab
1 Instructions for use