Assessment of the Immulite systems CMV IgM assays in comparison to the Vidas assay in a clinical evaluation
Abstract number: 1733_945
Vlaspolder F., Singer P.
Objective: Cytomegalovirus (CMV) belongs to the herpesvirus family with other well-known viruses such as Herpes Simplex Virus (HSV), Varicella Zoster Virus (VZV) and Epstein-Barr Virus (EBV). CMV is found throughout the world and although the infection can be asymptomatic in the general population, it can cause severe infections in immunocompromised individuals and in newborns of infected pregnant women. The objective of this study was to evaluate the clinical performance of the DPC IMMULITE® systems' CMV IgM assay to that of the bioMérieux VIDAS® for detection of IgM antibodies to CMV.
Methods: A total of 523 samples were analysed on the two DPC IMMULITE platforms and the bioMérieux VIDAS system. Included in the sample population were 158 pregnancy samples, 37 samples from transplant cases, 68 samples defined as primary CMV infections, 153 known negatives, 15 BBI panel, 44 cross-reactives (RFand toxoplasma IgM) and 48 samples defined as EBV infections.
Results: The overall agreement to the VIDAS assay was 92.3% for IMMULITE and 92.8% for IMMULITE 2000. In assessing the performance of the IMMULITE assays within the specific populations tested, the Mikrogen® CMV recombinant immunoblot, clinical findings if available, and EBV serology were used to further analyse the true IgM reactivity to CMV. Upon resolution of discordant results with these additional methods, the IMMULITE assays and the VIDAS assay showed acceptable agreement within the specified patient populations.
Based on the blot results, some samples originally identified with the VIDAS assay as CMV reactive cases, were reclassified as EBV infections. Of the 48 samples identified as reactive to EBV and non-reactive to CMV, the IMMULITE (2000/One) assays resulted correctly in up to 37/39 of the 48 cases, while the VIDAS assay resulted correctly in up to 23 of the 48 cases
Conclusion: Overall analysis of the IMMULITE and VIDAS results indicates that the IMMULITE CMV IgM assays are comparable in performance to the VIDAS assay in all sample populations tested. Additionally, the IMMULITE assays have a lower level of cross reactivity interference to EBV, suggesting a higher level of accuracy in reporting a true CMV IgM result.
|Session name:||European Society of Clinical Microbiology and Infectious Diseases|
|Location:||ICC, Munich, Germany|
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