The CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for then 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
Principles of the test:
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.
- Product not for sale to individuals or non-medical related businesses, organizations or establishments
- Any orders shipped to a personal address or non-medical business address will be voided and refunded
- Identify individual’s current infection status to COVID-19
- Fast and easy to use in Point-of-Care setting
- Qualitatively detect the SARS-CoV-2 nucleocapsid protein
- Use nasopharyngeal (NP) swab specimens
- Reliable results only in 10 minutes
- No special equipment or training required
- All-in-one package including collection swabs
- High sensitivity (88.4%) and specificity (100%)