CARESTART COVID-19 ANTIGEN RAPID TEST (1 KIT OF 20 TESTS)

Description

1 Kit Contains 20 Rapid Tests

Instructions for Use
FDA Emergency Use Authorization Letter
Fact Sheet for Healthcare Providers
Fact Sheet for Patients

Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved
Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 34° – 86° F
Processing Time: Approximately 10 Minutes

Intended to be a point-of-care (POC) test, the CareStart COVID-19 Antigen Rapid Test has a 10 minute processing time and allows effective screening of COVID-19 infection on a large scale without the use of a separate analyzer.

• • Minimally invasive specimen collection (nasopharyngeal)
  • Lateral flow assay
  • Rapid results in 10 minutes (do not read after 15 minutes)
  • Intended for point-of-care settings by medical professionals
  • CLIA waived
  • For in vitro diagnostic use only