Description
Fact Sheet for Patients
FDA Emergency Use Authorization Letter
Fact Sheet for Healthcare Providers
Stat Carestart Flyer
Expiration Extension Notice
Package Insert/Instructions for Use
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.
Contents: Test device (20), Extraction vial (20), Cap (20)caps, swabs (20), Positive control swab (1), Negative control swab (1) each, Package insert (1), Instructions for use (1) Quick Reference Instructions (QRI) (1)
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 1° – 30° C
Processing Time: Approximately 10 Minutes
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 swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset.
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
- 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
The CareStart™ COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings. The CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization
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., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
See product links above for additional information or contact your local Stat Technologies sales representative
