Bio-Rad’s coronavirus Ag Rapid Test, an antigen test used to detect the nucleocapsid protein antigen in SARS-CoV-2, offers flexibility in detecting the virus and includes a quality control swab kit. The products met CE mark requirements for European markets earlier this year.
The test and quality control swab kits are included in the official list of antigen tests recommended by several European governments for the detection of the nucleocapsid protein found in SARS-CoV-2. The in vitro immunochromatographic test provides a method of detecting the SARS-CoV-2 antigen in the early stages of COVID-19 infection. It can be used in a laboratory or in a point of care setting.
Clinical evaluation of the test was performed at seven sites with 237 fresh nasal swab specimens and 865 fresh nasopharyngeal swab specimens collected and tested in a randomised blinded study. The test evaluated the test’s performance for both nasal and nasopharyngeal swab specimens, with 100% and 99.60% specificity, and 97.25% and 98.32% sensitivity respectively, at the test sites.
Bio-Rad provides a range of additional products and services to assist COVID-19 response including diagnostic screening of the virus, confirmation of test results, surveillance, as well as products that support therapy and vaccine research and development.
