About the Tests:
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.
- Internal Quality Control: The CareStart™ COVID-19 Antigen contains a built-in internal procedural control that is included in the test device. A red-colored line appearing in the control region “C” is designed as an internal procedural control. The appearance of the procedural control line indicates that sufficient flow has occurred, and the functional integrity of the test device has been maintained. If the procedural control line does not develop in 10 minutes, the test result is considered invalid and retesting with a new device is recommended. If the internal procedural control line is still absent in the retest, please contact Technical Support at +1- 888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or [email protected] (24/7available).
- External Control: External control is used to demonstrate that the test device and test procedure perform properly. It is recommended that positive and negative external control swabs are run once with every new lot, shipment, and each new user. External positive and negative control swabs are provided in the kit. The external control should be tested using the nasopharyngeal swab test procedure provided in this package insert or the quick reference instruction card. If the external control results are invalid, please contact Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or [email protected] (24/7 available) before testing patient specimens.