CareStart Antigen Rapid Test

Description

CareStart Antigen Test Diagram: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein. EUA Authorized: October 8, 2020Test Type: Rapid Antigen; Nucleocapsid

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 swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset.

Nasopharyngeal swabs require a sample preparation step in which the sample is eluted into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles in the test strip forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. Test results are interpreted at 10 minutes.

The presence of two colored lines in the control line region “C” and test line region “T” indicates COVID-19 positive. The presence of one colored lines in the control line region “C” indicates COVID-19 negative. No appearance of a colored line in the control region “C” indicates an invalid test.

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

Intended to be a point-of-care (POC) test, the CareStart COVID-19 Antigen

Rapid Test has a 10 minute processing time and allows effective screening of COVID-19 infection on a large scale without the use of a separate analyzer.

• Minimally invasive specimen collection (nasopharyngeal)

  1. Lateral flow assay

  2. Rapid results in 10 minutes (do not read after 15 minutes)

  3. Intended for point-of-care settings by medical professionals

  4. CLIA waived

  5. For in vitro diagnostic use only

  6. Prescription use only

This will detect the current European mutations as well!