The test designed to detect SARS-CoV-2 will be available in Europe later this month and provides results in 15 minutes.
Roche announced yesterday it was launching its SARS-CoV-2 Rapid Antigen Test in Europe at the end of September. The test provides results in 15 minutes and provides the possibility to more efficiently assess and treat patients.
“Testing continues to be an important focus for many countries. Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Thomas Schinecker, CEO of Roche Diagnostics, stated. “COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus. We are working relentlessly to deliver solutions that help alleviate some of the healthcare burden with reliable SARS-CoV-2 testing solutions as we learn more about the disease and how it affects people around the world.”
Roche’s test is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.
This provides instrument-free testing kit, and provides a yes or no answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip.
The company said there will be 40 million tests available per month, and this capacity will increase more than two-fold at the end of this year to help with testing demands.
In addition, Roche said it had planned to follow-up with The US Food and Drug Administration (FDA) for an Emergency Use Authorization for the test.