Description
Carestart Antigen Home Test Package Insert
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: 232 Kits. Each kit contains: Test device (2), Extraction vial (2), Cap (2), swabs (2), 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 Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
All following required components for single-use are packed and sealed in a tray.
• a test device: foil pouched test device containing one test strip which is encased in plastic device cassette with a desiccant.
• an extraction vial and cap: the extraction vial contains 500 µL of extraction buffer solution.
• a nasal swab: swab for anterior nasal specimen collection.
Quick Reference Instructions and Fact Sheet for Individuals are also included in each box
See product links above for additional information or contact your local Stat Technologies sales representative
