Evaluation of the new LIAISON(®) CMV IgG, IgM and IgG Avidity II assays.

Background: The diagnosis of CMV infection is challenging and the quality of serological laboratory testing is critical, especially in pregnancy and in the determination of transplant recipients and donors serostatus.

Objectives: Evaluate the performances of the new LIAISON(®) CMV II line: LIAISON(®) CMV IgG II, LIAISON(®) CMV IgM II and LIAISON(®) CMV IgG Avidity II in comparison with the routine methods used in our laboratory.

Study Design: The evaluation of LIAISON(®) CMV IgG II and LIAISON(®) CMV IgM II was performed on both prospective routine samples and retrospective selected samples for a total of 383 sera. CMV IgG avidity was assessed with 88 samples.

Results: The overall agreement was 98.8% for the IgG and 95% for the IgM on the routine population. On selected retrospective samples, excellent agreement was found in the seronegative and past infection groups. In the recent infection group, discordances were observed in 7.1% of IgG and 13.1% of IgM. No recent infection was missed with LIAISON(®). Avidity agreement with VIDAS(®) was 81%. On 51 sera with a known time of infection, no high avidity was found in the group infected for less than 3 months and 82% of the samples showed a high avidity in the group infected for more than 3 months.

Conclusion: The performances of the fully automated LIAISON(®) CMV II line assays are comparable to those of the reference methods used in our lab for both prospective and selected populations. This new CMV line is a useful tool for the diagnosis of CMV infections and CMV immune status in clinical settings.