Big Data analysis to evaluate the clinical utility of IgM anti SARS-CoV-2 determination: The Modena experience
Biochimica Clinica
; 46(2):154-159, 2022.
Article
in Italian
| EMBASE | ID: covidwho-1988759
ABSTRACT
Introduction:
since the scarce diagnostic accuracy of specific circulating antibodies for SARS-CoV-2, we aimed to assess the clinical utility of IgM detection in SARS-CoV-2 using the Big Data analysis.Methods:
this is a retrospective study;all the blood samples collected between March and September 2020 were processed using a lateral flow immunoassay (LFIA) kit for IgG and IgM antybody testing. Positives results were tested again using a chemiluminescent method. Subjects confirmed with a positive result were contacted for a molecular test.Results:
more than 69 000 serological tests (from 42 911 subjects) were performed. 94.5% (40 559/42 911) of subjects had negative results for both IgG and IgM. 1.5% (n = 640) subjects had both IgG and IgM positive results, and viral RNA research confirmed positivity in 16% (85/533). Among subjects with IgG negative and IgM positive results (n=271), a positivity was confirmed in 1% (4/270). Conversely, in subjects with IgG positive and IgM negative results, a positivity was confirmed in 8% (97/1 215). Therefore, the analysis suggests that up to 98% of serological test results of IgM positivity and IgG negativity are false positive.Discussion:
the study, based on Big Data analysis application, proved the scarce clinical utility of IgM detection in COVID-19 management, and underlines the responsibility of laboratory professionals in highlighting the limitations of the serological tests also due to uncertainty in their interpretation.
adult; article; big data; blood sampling; chemoluminescence; clinical evaluation; controlled study; coronavirus disease 2019; diagnostic accuracy; diagnostic test accuracy study; female; human; laboratory personnel; lateral flow immunochromatography; major clinical study; male; nonhuman; null result; responsibility; retrospective study; serology; Severe acute respiratory syndrome coronavirus 2; uncertainty; endogenous compound; immunoglobulin G; immunoglobulin M; virus RNA
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Experimental Studies
/
Prognostic study
Language:
Italian
Journal:
Biochimica Clinica
Year:
2022
Document Type:
Article
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