COVID-19 Anitobdy Testing
COVID-19 Antigen

Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

Test Principles

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 swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers.

Features

- Lateral flow assay

-Rapid results in 10 minutes

- Minimally invasive specimen collection (nasopharyngeal)

-Intended at POC setting (i.e., in patient care settings) by medical professionals

Clinical Features

- Detect SARS-CoV-2 nucleocapsid protein antigen

- Identify acute infection with high sensitivity and 100% specificity

Results Interpretation

Read the result at 10 minutes. The test result should not be read after 15 minutes

Positive

SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered positive.

Negative

Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.

Invalid

Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.