Evaluation reveals excellent correlation in CMV IgG testing in 153 specimens, suggesting reliability for screening.
Background CMV or cytomegalovirus infections are very common in most countries worldwide. The danger arises in pregnancy if mothers do not have pre-existing IgG antibodies for the virus, as acute infections or re-activation of the virus are harmful to the fetus. Depending on clinical symptoms, pregnant mothers may be screened for the presence of anti-CMV IgG. Methods The Alinity i CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) and awas compared to the FDA-cleared Liason CMV IgG assay on a cohort of 153 specimens. Discrepancies between the assays were further tested for Avidity and CMV IgM. Results Correlation between the Alinity and the Liason CMV IgG methods showed an r of 0.91, Concordance as measured was excellent with a Kappa of 0.96 (0.92 to 1.00). Of the 153 specimens tested, 74 were positives, 76 negatives by both methods. 3 specimens were discrepant between the methods: 1 Liason low positive and Alinity non-reactive, 1 Liason negative and Alinity Grayzone, and 1 Liason negative and Alinity reactive. The discrepant reflex testing indicated that the specimen showing grayzone /negative results was also IgM positive (therefore and acute infection) and the specimen showing positive Alinity/ negative Liaison results was negative for IgM and a high avidity specimen. Conclusion The Alinity I and the Liaison CMV IgG assays demonstrated excellent concordance and correlation.
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Ian L. Gunsolus (2025) studied this question.
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