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Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies.
J Clin Microbiol. 2021 05 19; 59(6)JC

Abstract

The World Health Organization (WHO) has targeted measles for global eradication through mass immunization. For effective monitoring of eradication targets, high-quality surveillance is needed. The detection of IgM antibodies, specific to the measles virus, with the use of commercial enzyme-linked immunosorbent assays (ELISA or EIA) is broadly used within the WHO global measles and rubella laboratory network for laboratory confirmation, and in particular, ELISA kits manufactured by Siemens (Enzygnost kits) have been primarily used. Spurred by the discontinuation of these kits, this study aims to report on the clinical sensitivity and specificity of comparable commercial ELISA kits and one automated chemiluminescent immunoassay (CLIA) method. A panel of 239 serum samples was assembled that included sera from confirmed measles cases (n = 50) and probable post-MMR vaccine response (n = 2). Measles-negative sera (n = 187) were collected from individuals presenting with other fever and rash illnesses. A total of 7 ELISA kits (Euroimmun native antigens and recombinant nucleoprotein, IBL, Clin-Tech Microimmune, NovaTec NovaLisa, Serion, and Siemens Enzygnost) and one CLIA method (DiaSorin LIAISON XL) were evaluated. The ELISA kits included two IgM capture methods and five indirect methods. Calculated sensitivities and specificities ranged from 75.0% to 98.1% and 86.6% to 99.5%, respectively. The parvovirus B19 IgM positive sera were noted to cause false-positive results, particularly for the ELISA kits from Serion and NovaLisa; specificities for this subset of samples ranged from 51.4% to 100.0%. The capture IgM ELISA methods provided the best combination of sensitivity and specificity.

Authors+Show Affiliations

Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada joanne.hiebert@canada.ca alberto.severini@canada.ca.Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.Public Health Laboratory, Alberta Precision Laboratories, Edmonton, Alberta, Canada. Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada. Li Ka Shing Institute of Virology, University of Alberta, Edmonton, Alberta, Canada.Public Health Laboratory, Alberta Precision Laboratories, Edmonton, Alberta, Canada.Public Health Laboratory, Alberta Precision Laboratories, Edmonton, Alberta, Canada. Li Ka Shing Institute of Virology, University of Alberta, Edmonton, Alberta, Canada. Department of Medical Microbiology and Immunology, University of Alberta, Edmonton, Alberta, Canada.Public Health Laboratory, Alberta Precision Laboratories, Edmonton, Alberta, Canada. Department of Microbiology, Immunology, and Infectious Disease, University of Calgary, Calgary, Alberta, Canada.Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada joanne.hiebert@canada.ca alberto.severini@canada.ca. Department of Medical Microbiology and Infectious Diseases, Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33731415

Citation

Hiebert, Joanne, et al. "Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies." Journal of Clinical Microbiology, vol. 59, no. 6, 2021.
Hiebert J, Zubach V, Charlton CL, et al. Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies. J Clin Microbiol. 2021;59(6).
Hiebert, J., Zubach, V., Charlton, C. L., Fenton, J., Tipples, G. A., Fonseca, K., & Severini, A. (2021). Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies. Journal of Clinical Microbiology, 59(6). https://doi.org/10.1128/JCM.03161-20
Hiebert J, et al. Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies. J Clin Microbiol. 2021 05 19;59(6) PubMed PMID: 33731415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of Diagnostic Accuracy of Eight Commercial Assays for the Detection of Measles Virus-Specific IgM Antibodies. AU - Hiebert,Joanne, AU - Zubach,Vanessa, AU - Charlton,Carmen L, AU - Fenton,Jayne, AU - Tipples,Graham A, AU - Fonseca,Kevin, AU - Severini,Alberto, Y1 - 2021/05/19/ PY - 2020/12/15/received PY - 2021/03/08/accepted PY - 2021/3/19/pubmed PY - 2021/7/10/medline PY - 2021/3/18/entrez KW - CLIA KW - EIA KW - ELISA KW - IgM KW - immunoserology KW - kit evaluation KW - measles KW - measles IgM serology KW - sensitivity KW - specificity JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 59 IS - 6 N2 - The World Health Organization (WHO) has targeted measles for global eradication through mass immunization. For effective monitoring of eradication targets, high-quality surveillance is needed. The detection of IgM antibodies, specific to the measles virus, with the use of commercial enzyme-linked immunosorbent assays (ELISA or EIA) is broadly used within the WHO global measles and rubella laboratory network for laboratory confirmation, and in particular, ELISA kits manufactured by Siemens (Enzygnost kits) have been primarily used. Spurred by the discontinuation of these kits, this study aims to report on the clinical sensitivity and specificity of comparable commercial ELISA kits and one automated chemiluminescent immunoassay (CLIA) method. A panel of 239 serum samples was assembled that included sera from confirmed measles cases (n = 50) and probable post-MMR vaccine response (n = 2). Measles-negative sera (n = 187) were collected from individuals presenting with other fever and rash illnesses. A total of 7 ELISA kits (Euroimmun native antigens and recombinant nucleoprotein, IBL, Clin-Tech Microimmune, NovaTec NovaLisa, Serion, and Siemens Enzygnost) and one CLIA method (DiaSorin LIAISON XL) were evaluated. The ELISA kits included two IgM capture methods and five indirect methods. Calculated sensitivities and specificities ranged from 75.0% to 98.1% and 86.6% to 99.5%, respectively. The parvovirus B19 IgM positive sera were noted to cause false-positive results, particularly for the ELISA kits from Serion and NovaLisa; specificities for this subset of samples ranged from 51.4% to 100.0%. The capture IgM ELISA methods provided the best combination of sensitivity and specificity. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/33731415/Evaluation_of_Diagnostic_Accuracy_of_Eight_Commercial_Assays_for_the_Detection_of_Measles_Virus_Specific_IgM_Antibodies_ DB - PRIME DP - Unbound Medicine ER -