Access Bio’s CareStart™ COVID-19 Antigen – Rapid POC T

Features:

  • 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 or nasopharyngeal swab specimens

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.