Original articleComparative evaluation of assays for IgM detection of rubella and measles infectionsEvaluación comparativa de ensayos para la detección de IgM en infecciones por rubéola y sarampión
Introduction
Rubella and measles infections are usually diagnosed in the laboratory by RT-PCR detection of the virus genomes during the first four days of the disease. However, samples taken at the appropriate time for making a direct diagnosis are not always available, so the detection of IgM-class antibodies is used as a fundamental tool for correct case characterization.1 Using a combination of the two approaches greatly improves the performance of measles2, 3 and rubella2 diagnosis. In a situation of elimination, such as the current one, serological tests with good sensitivity and specificity characteristics are required. Siemens Healthcare Diagnostics (Marburg, Germany) (ELISA-Siemens) currently supplies the reference methods (ELISA assays, Enzygnost®) for determining IgM against rubella (RuV) and measles (MeV) viruses. The Enzygnost® kits have been used by a large number of network laboratories for many years.4, 5 However, they will soon be withdrawn from the market, so the identification of alternative methods with acceptable performance characteristics is a challenge for clinical laboratories.
The aim of this study is to assess the operating characteristics of ELISA assays, based on indirect or μ chain capture methodologies, and chemiluminescence (CLIA) (capture), all for the purpose of determining the levels of IgM against RuV and MeV, and of electrochemiluminescence (ECLIA) (capture), for determining IgM versus RuV. Seven assays were compared for RuV IgM and six for MeV IgM.
Section snippets
Serological methods
The following assays were studied (Table 1):
- 1.
Rubella assays
- i.
Enzygnost Rubella IgM, Siemens (Marburg, Germany) (RuV-ELISA-Siemens). The determinations were carried out in a Behring ELISA Processor III (BEPIII) (Siemens).
- ii.
Serion ELISA Classic Rubella IgM, Serion (Würzburg, Germany) (RuV-ELISA-Serion). The determinations were done in a BEPIII.
- iii.
Anti-Rubella IgM ELISA, EuroImmun (Lübeck, Germany) (RuV-ELISA-Euroimmun-1). The assay was done manually, and the plates were read in a BEPIII.
- iv.
Anti-Rubella IgM
Rubella assays
Of the rubella samples, 74 were classified as positive (≥4 positive results), 15 as negative (≥4 negative results), and one as indeterminate (Table 2). Of the positive samples, 67 were positive in all the assays, and six of the negative samples were negative in all the assays.
When analyzing the measles samples, three were identified as positive for RuV-IgM (confirmed as double infections) and one as indeterminate for rubella IgM, in a MeV IgM-positive case. Thirty-two samples were negative in
Discussion
In 2018, measles and rubella were eliminated in 35 (66%) and 39 (73%) of the Member States of the WHO European Region.6 This was made possible by adequate vaccine coverage and surveillance systems, and the availability of sensitive and specific diagnostic methods, using both direct detection by PCR and serological determination of specific IgMs. In recent years, the most commonly used methods for determining specific IgMs against RuV and MeV have been those of Enzygnost® Siemens. These methods
Conflict of interest
The authors declare that they have no conflict of interest.
Acknowledgements
This work was supported by the Fondo de Investigación Sanitaria (grant number FIS PI15CIII/00023).
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