The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal and nasal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.
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