In the next blog post, we`ll show you how to use Analysis-it to perform the contract test with a treated example. The document was also the first time that the FDA had set minimum performance criteria for COVID-19 tests; In state-led validation studies, the serological tests obtained by the ERA must have a sensitivity of 90% and a specificity of 95%, with at least 30 samples of patients with a positive antibody and 80 negative control samples. To avoid confusion, we recommend that you always use the terms positive agreement (AAE) and negative agreement (NPA) when describing the agreement of these tests. In the absence of such a standard for COVID-19, serological developers have reported sensitivity and specificity as a positive prediction agreement (AAE) or negative preaching agreement (NPA) with RT-PCR tests on patients` nasal skinners. Because specificity/APA reflects the ability to accurately identify negative controls, which are more widely available than patient samples, IC tends to be narrower for these metrics than in sensitivity/AAE, allowing for consideration of the proportion of positive cases a test can find. One of the frequently used clinical relevance metrics is positive predictive value (APP), the proportion of total positive values and test reports that are actually positive. As a result, a test that goes well in populations with a high rate of actual positive cases may be woefully inadequate in populations with low prevalence. The FDA has issued nine COVID-19 antibody tests for Emergency Use Authorization (EEA). The application document (IFU) for each test indicates its sensitivity and specificity in the form of a positive percentage agreement (AEA) or a negative percentage agreement (NPA) with a chain reaction test by reverse transcription polymeraosis (RT-PCR) and 95% confidence intervals (IC) for each value. CLSI EP12: User Protocol for Evaluation of Qualitative Test Performance Protocol describes the terms of the Positive Percentage Agreement (AEA) and the Negative Performance Agreement (NPA). If you have two binary diagnostic tests to compare, you can use an agreement study to calculate these statistics. As more and more people are exposed to COVID-19 and effective vaccines are being put online, the prevalence of SARS-CoV-2 antibodies will increase in the population, making positive individual test results more trustworthy. The clinical relevance of a test depends on the prevalence of the condition detected.