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10.1016/j.cmi.2020.06.024 http://scihub22266oqcxt.onion/10.1016/j.cmi.2020.06.024 32603801!7320699!32603801     free     free     free Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Clin+Microbiol+Infect 2020 ; 26 (10): 1386-1394 Nephropedia Template TP {{tp|p=32603801|t=2020. Validation of a commercially available SARS-CoV-2 serological immunoassay |pdf=|usr=}}{{32603801}} gab.com Text Validation of a commercially available SARS-CoV-2 serological immunoassay JO: Clin Microbiol Infect http://www.kidney.de/pget.php?&tw=1&pmid=32603801 #FOAvip OBJECTIVES: To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19. METHODS: In this unmatched (1:2) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 326 controls collected before SARS-CoV-2 emergence. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay. RESULTS: COVID-19 patients were more likely to be male and older than controls, and 50.3% were hospitalized. ROC curve analyses indicated that IgG and IgA had high diagnostic accuracies with AUCs of 0.990 (95% Confidence Interval [95%CI]: 0.983-0.996) and 0.978 (95%CI: 0.967-0.989), respectively. IgG assays outperformed IgA assays (p=0.01). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 2.5 displayed a 100% specificity (95%CI: 99-100) and a 100% positive predictive value (95%CI: 96-100). A 0.8 cut-off displayed a 94% sensitivity (95%CI: 88-97) and a 97% negative predictive value (95%CI: 95-99). Substituting the upper threshold for the manufacturer's, improved assay performance, leaving 8.9% of IgG ratios indeterminate between 0.8-2.5. CONCLUSIONS: The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals in our study population have been exposed to SARS-CoV-2 or not. IgG serology should however not be considered as a surrogate of protection at this stage. Twit Text FOAVip Validation of a commercially available SARS-CoV-2 serological immunoassay ????Clin Microbiol Infect http://www.kidney.de/pget.php?&tw=1&pmid=32603801 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32603801 #FOAvip English Wikipedia <ref>{{Cite pmid|32603801}}</ref> Validation of a commercially available SARS-CoV-2 serological immunoassay #MMPMID32603801 Meyer B; Torriani G; Yerly S; Mazza L; Calame A; Arm-Vernez I; Zimmer G; Agoritsas T; Stirnemann J; Spechbach H; Guessous I; Stringhini S; Pugin J; Roux-Lombard P; Fontao L; Siegrist CA; Eckerle I; Vuilleumier N; Kaiser L Clin Microbiol Infect 2020[Oct]; 26 (10): 1386-1394 PMID32603801show ga OBJECTIVES: To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19. METHODS: In this unmatched (1:2) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 326 controls collected before SARS-CoV-2 emergence. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay. RESULTS: COVID-19 patients were more likely to be male and older than controls, and 50.3% were hospitalized. ROC curve analyses indicated that IgG and IgA had high diagnostic accuracies with AUCs of 0.990 (95% Confidence Interval [95%CI]: 0.983-0.996) and 0.978 (95%CI: 0.967-0.989), respectively. IgG assays outperformed IgA assays (p=0.01). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 2.5 displayed a 100% specificity (95%CI: 99-100) and a 100% positive predictive value (95%CI: 96-100). A 0.8 cut-off displayed a 94% sensitivity (95%CI: 88-97) and a 97% negative predictive value (95%CI: 95-99). Substituting the upper threshold for the manufacturer's, improved assay performance, leaving 8.9% of IgG ratios indeterminate between 0.8-2.5. CONCLUSIONS: The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals in our study population have been exposed to SARS-CoV-2 or not. IgG serology should however not be considered as a surrogate of protection at this stage. |Adult[MESH] |Antibodies, Viral/*blood[MESH] |Area Under Curve[MESH] |Betacoronavirus/*immunology[MESH] |COVID-19[MESH] |COVID-19 Testing[MESH] |Case-Control Studies[MESH] |Child[MESH] |Clinical Laboratory Techniques/*methods[MESH] |Coronavirus Infections/*diagnosis/immunology/physiopathology/virology[MESH] |Female[MESH] |Humans[MESH] |Immune Sera/chemistry[MESH] |Immunoassay/*standards[MESH] |Immunoglobulin A/*blood[MESH] |Immunoglobulin G/*blood[MESH] |Male[MESH] |Pandemics[MESH] |Pneumonia, Viral/*diagnosis/immunology/physiopathology/virology[MESH] |ROC Curve[MESH] |SARS-CoV-2[MESH] |Sensitivity and Specificity[MESH]Validation of a commercially available SARS-CoV-2 serological immunoas(epmc).pdf DeepDyve Pubget Overpricing