Comparison of Three Automated Immunoassay Methods for the Determination of Epstein-Barr Virus-Specific Immunoglobulin M

In this study we compared the performances of three commercially available Epstein-Barr virus (EBV) immunoglobulin M (IgM) assays on highly automated immunoassay platforms: BioPlex 2200 (Bio-Rad Laboratories), Immulite 2000 (Siemens Healthcare Diagnostics), and Liaison (DiaSorin). As a confirmatory method, immunoblotting was performed. The specificity of the three EBV IgM assays was evaluated by testing 293 selected sera from patients with various infectious and noninfectious diseases. After the exclusion of 30 samples, the specificities were 96.2% for Liaison, 98.1% for Immulite, and 97.0% for BioPlex. For evaluation of the sensitivity, samples from 70 consecutive patients with a positive heterophile antibody test were examined, irrespective of clinical or biological findings. After the exclusion of six samples, the sensitivities were 89.1% for Liaison, 84.4% for Immulite, and 89.1% for BioPlex. Finally, in a prospective study performed with 500 samples obtained from consecutive patients and sent in by general practitioners, we also determined Epstein-Barr nuclear antigen IgG and viral capsid antigen IgG in a two-phase approach. Concordance of the EBV serologic status was 96.2% between Liaison and Immulite, 96.4% between Immulite and BioPlex, and 97.8% between BioPlex and Liaison. The three EBV IgM immunoassays that we evaluated have acceptable and comparable performances.Epstein-Barr virus (EBV) is the causative agent of infectious mononucleosis, a clinical syndrome characterized by especially fever, pharyngitis, and adenopathy. However, many other pathogens, such as cytomegalovirus (CMV), human herpesvirus 6, Toxoplasma gondii, human immunodeficiency virus, parvovirus B19, and herpes simplex virus, can cause mononucleosislike illnesses (6, 12). In primary care, the diagnostic approach to infectious mononucleosis frequently involves the determination of EBV-specific IgM antibodies. The ideal EBV-specific IgM assay should not only be sensitive and specific; in the modern laboratory automation, throughput, speed, accessibility, standardization, ease of use, and flexibility also play an important role. In the past decade, several immunoassay methods have been commercialized that may be able to meet most of these criteria (4, 7, 14).The present study was designed to compare the performances of three EBV IgM assays on highly automated random access platforms: BioPlex 2200 (Bio-Rad Laboratories), Immulite 2000 (Siemens Healthcare Diagnostics), and Liaison (DiaSorin). It was performed in a two-phase approach. First, using 363 selected samples we determined the sensitivities and specificities of the EBV IgM assays. In a second approach we prospectively determined the EBV serologic status on samples from 500 different consecutive patients for which EBV IgM determination was requested by general practitioners.