US-made intended point-of-care (POC) test results in minutes.
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 anterior nares swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStart™ COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike. Features and Benefits
- Lateral flow assay
- No equipment required
- Rapid results at 10 minutes
- Minimally invasive specimen collection (nasopharyngeal swabs)
- Detect SARS-CoV-2 nucleocapsid protein antigen with ultra high performance
- Test is only authorized at this time for POC use by qualified healthcare professionals.
- Test is only authorized for a diagnostic indication.
- Clinical performance
- 93.75% Positive Percentage Agreement (PPA) and 99.32% Negative Percent Agreement (NPA) when used with with nasopharyngeal swab
- 87.18% Positive Percentage Agreement (PPA) and 99.32% Negative Percent Agreement (NPA) when used with with anterior swab
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Specimen Collection and Handling
Test Procedure Steps
- 20 Test Devices
- 20 Assay Buffer
- 20 Extraction Vials and Caps
- 20 Specimen Collection Swabs
- 1 Positive and 1 Negative Control Swabs
- 1 Instructions of Use
- 87811 (SARS antigen visually read)
- National average reimbursement: $41/test
IFU SheetFact Sheet for PatientsFact Sheet for Healthcare ProvidersFDA EUA Letter