SensNews April 2020

11 Sensor100 2020 COVID-19 testing:What you need to know about test accuracy The global diagnostics community has raced to meet the unprecedented need for tens of millions of tests for SARS-CoV-2, the novel coronavirus that causes COVID-19. In addition to our cobas® SARs CoV-2 test, many tests from other diagnostic companies have received Emergency Use Authorization (EUA) by the U.S. Food and Drug Admin- istration (FDA), greatly improving our national testing capacity. No one company could come close to fulfilling the ever-growing global need for tests. Given these tests were developed quickly and under emergency circumstances, it’s no surprise that people have questions and concerns about their accuracy. You can think of test accuracy in two ways: ƒ If I have the disease, will the test correctly identify it? This is known as test sensi- tivity, or a true positive rate. ƒ If I don’t have the disease, will the test correctly show that? This is known as specificity, or a true negative rate. One thing to keep in mind is that no diagnostic test offers perfect performance.With any test, there will always be some false positives (the test says you have the disease when you actually don’t) and false negatives (the test says you don’t have the disease when you actually do). Read more... Roche COVID-19 Blog 2 0 April