Evaluation of the IMMULITE® 2000 CMV IgM assay

Tricia A Bal,Glenn Armstrong,Xiang Y Han

doi:10.1186/2042-4280-3-2

Tricia A Bal, Glenn Armstrong + Show 1 more

Open Access

https://doi.org/10.1186/2042-4280-3-2

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Abstract

BackgroundDiagnosis of cytomegalovirus (CMV) infection is challenging because of the high rate of asymptomatic infection and the low specificity of associated symptoms and signs. As a result, laboratory testing is an essential aid in making an accurate diagnosis. The presence of CMV IgM is indicative of primary CMV infection. In pregnancy, diagnosis of primary infection is important because primary maternal infection increases fetal infection risk substantially. Fetal infection can result in serious sequelae ranging from neurological deficits to death. Diagnosis among the immunocompromised is also critical for the timely initiation of therapy that can reduce morbidity and mortality risk.MethodsThe IMMULITE® 2000 CMV IgM assay qualitatively detects CMV IgM antibodies in human serum or plasma to aid in the diagnosis of current or recent CMV infection. To determine expected values in apparently healthy subjects, 136 samples were tested. Reproducibility, normal range, and method comparison studies were also performed to evaluate the assay's performance. The assay's reproducibility was evaluated across three sites. Seven hundred and eighteen (n = 718) individual patient serum samples, which included samples from CMV IgM-positive (n = 109, determined by the Abbott IMx CMV or the Diamedix CMV IgM assays), pregnant (n = 210), HIV-positive (n = 30), immunosuppressed (n = 102), and transplant patients (n = 17) and from patients with potentially cross-reacting conditions (n = 136) were evaluated in the method comparison study. The positive, negative, and overall agreement between the IMMULITE 2000 CMV IgM assay and the VIDAS CMV IgM assay (predicate assay) were determined.ResultsThe assay demonstrated excellent reproducibility with a total CV of less than 10%. The positive, negative, and overall agreement between the IMMULITE 2000 assay and the VIDAS assay were > 95% for the method comparison samples. Among potentially cross-reactive samples, the overall agreement between the two assays was 96%. Similarly, among the immunocompromised and pregnant subjects, the overall agreement was ~96% and ~97%, respectively.ConclusionsThe IMMULITE 2000 CMV IgM assay demonstrated excellent reproducibility, minimal cross-reactivity, and performance comparable to that of the VIDAS CMV IgM assay. It can aid in the diagnosis of acute CMV or recent CMV infection by qualitatively detecting the CMV IgM antibodies in human serum or plasma.

Highlights

Diagnosis of cytomegalovirus (CMV) infection is challenging because of the high rate of asymptomatic infection and the low specificity of associated symptoms and signs
The IMMULITE 2000 CMV IgM assay is for the qualitative detection of IgM antibodies to CMV in human serum or plasma, as an aid in the diagnosis of current or recent CMV infection (Table 1)
The VIDAS® CMV IgM assay is intended to be used as an aid in the diagnosis of cytomegalovirus infection (Table 1)

Summary

Introduction

Diagnosis of cytomegalovirus (CMV) infection is challenging because of the high rate of asymptomatic infection and the low specificity of associated symptoms and signs. Seven hundred and eighteen (n = 718) individual patient serum samples, which included samples from CMV IgMpositive (n = 109, determined by the Abbott IMx CMV or the Diamedix CMV IgM assays), pregnant (n = 210), HIVpositive (n = 30), immunosuppressed (n = 102), and transplant patients (n = 17) and from patients with potentially cross-reacting conditions (n = 136) were evaluated in the method comparison study. In pregnancy and among the immunocompromised, CMV infection can have severe consequences, and in these groups, laboratory testing is a vital aid in facilitating timely, appropriate interventions. In pregnancies with primary infection, the rate of fetal infection is approximately 32% to 38% [1]. In pregnancies with reactivation or reinfection, the rate of fetal infection is only ~1% [1,2,3]

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