CareStart Antigen COVID 19 Test - Ag Rapid Point of Care SARS-CoV-2

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SKU:
ACSBCOV-502A
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Description

The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
 
  • Lateral flow assay
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Rapid results within 10-15 minutes
  • Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • For use under the Emergency Use Authorization (EUA) only
  • For in vitro diagnostic use only
  • For prescription use only
  • For use with direct anterior nasal and nasopharyngeal swab specimens

Clinical Performance

  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • 87.18% PPAa and 100% NPAb when used with anterior nasal swab
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.
  • 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
  • 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.


    Fact Sheet for Healthcare Providers
     
    Fact Sheet for Patients
     
    Package Insert (Instructions for Use)
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