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10.1128/mSphere.00201-21 http://scihub22266oqcxt.onion/10.1128/mSphere.00201-21 33980676!8125050!33980676     free     free     free       mSphere 2021 ; 6 (3): ä Nephropedia Template TP {{tp|p=33980676|t=2021. Antibody (Serology) Tests for COVID-19: a Case Study |pdf=|usr=}}{{33980676}} gab.com Text Antibody (Serology) Tests for COVID-19: a Case Study JO: mSphere http://www.kidney.de/pget.php?&tw=1&pmid=33980676 #FOAvip Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. Despite serious limitations on the interpretation of a positive antibody test in terms of immunity to SARS-CoV-2, antibody testing was initially considered for release from social distancing, return to employment, and "immunity passports." The regulatory approach to antibody tests was limited; manufacturers were encouraged to develop and market antibody tests without submitting validation data to the FDA. FDA guidance grew more stringent, but many poor-quality tests were already on the market-potentially inappropriately used for individual decision-making. This is a case study describing COVID-19 serology tests and the U.S. market and describes lessons learned for a future health security crisis. Twit Text FOAVip Antibody (Serology) Tests for COVID-19: a Case Study ????mSphere http://www.kidney.de/pget.php?&tw=1&pmid=33980676 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33980676 #FOAvip English Wikipedia <ref>{{Cite pmid|33980676}}</ref> Antibody (Serology) Tests for COVID-19: a Case Study #MMPMID33980676 West RM; Kobokovich A; Connell N; Gronvall GK mSphere 2021[May]; 6 (3): ä PMID33980676show ga Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. Despite serious limitations on the interpretation of a positive antibody test in terms of immunity to SARS-CoV-2, antibody testing was initially considered for release from social distancing, return to employment, and "immunity passports." The regulatory approach to antibody tests was limited; manufacturers were encouraged to develop and market antibody tests without submitting validation data to the FDA. FDA guidance grew more stringent, but many poor-quality tests were already on the market-potentially inappropriately used for individual decision-making. This is a case study describing COVID-19 serology tests and the U.S. market and describes lessons learned for a future health security crisis. |*Pandemics[MESH] |Antibodies, Viral/*blood[MESH] |Asymptomatic Infections[MESH] |COVID-19 Serological Testing/history/*methods/standards[MESH] |COVID-19/*diagnosis[MESH] |Forecasting[MESH] |Health Policy[MESH] |Health Services Needs and Demand[MESH] |History, 21st Century[MESH] |Humans[MESH] |Immunoglobulin G/blood[MESH] |Immunoglobulin M/blood[MESH] |Marketing of Health Services[MESH] |Politics[MESH] |Quality Control[MESH] |SARS-CoV-2/*immunology[MESH] |Sensitivity and Specificity[MESH] |United States[MESH] |United States Food and Drug Administration[MESH]Antibody (Serology) Tests for COVID-19: a Case Study (epmc).pdf DeepDyve Pubget Overpricing