CareStart™ COVID-19 Rapid Antigen Test
Fast, accurate, point-of-care results.
Access Bio’s rapid antigen test is CLIA Waiver and point-of-care authorized. With results in 15 minutes and a visual readout with no analyzer required, CareStart™ is the fastest way to diagnosis COVID-19.
General Details
Test type: Antigen
Run time: 10-15 minutes
Collection type: Lower nasal swab or nasopharyngeal
Authorization: FDA EUA for professional use. CLIA required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Manufacturer: Access Bio (USA)
CPT Codes: Covid-19 87811QW
Clinical Details
SARS-CoV-2: 88.4% Sensitivity, 100.0% Specificity
Specificity: No cross-reaction with species tested
Interference: No interfering factors tested except biotin
*See Instructions For Use for detailed clinical data.
Box Components
Lower nasal swabs (20)
Test cassettes (20)
Extraction reagent capsules (20)
Positive control swab (1)
Negative control swab (1)
Instructions for use (1)
Quick reference guide (1)
Storage & Handling
Test kits should be stored at 1-30°C (33-86°F). Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.
Manuals and Instructions
Product Images
