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The aim of the article was to analyze the importance of assay specificity and calculate the required threshold for the tests to provide clinically relevant information The study urges COVID-19 Ab kit manufacturers to check thoroughly the specificity of their COVID-19 Ab assays by using sera from patients with various autoimmune conditions (about 5% prevalence in the US population) and patients positive for heterophilic antibodies (about 1% prevalence in the general population;these patients have serum antibodies with broad and unpredictable specificities against human and animal antibodies) and other infections with diverse viruses (optimally including SARS-CoV and other \'common-cold\' CoVs), to make sure of no cross-reactivity Universal standardizations and assay harmonizations would contribute tremendously to minimal analytical variability between kits The high urgency for new SARS CoV-2 serological tests should not compromise assay quality standards FP results could lead to vital errors both in prevalence prediction studies and in misleadingly reassuring patients of presumed immunity, thus allowing them to return to societal activities at a great risk of getting infected and further spreading the virus
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Clinical_Chemistry_and_Laboratory_Medicine
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Antibody tests for COVID-19: drawing attention to the importance of analytical specificity. (Special Issue: Critical role of laboratory medicine in the global response to the COVID-19 pandemic.)
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