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Published on: December 12, 2011
Evaluation of the IMMULITE® 2000 CMV IgM assay
Tricia A Bal1, Glenn Armstrong1, Xiang Y Han2
1Siemens Healthcare Diagnostics, Los Angeles, CA, USA.
Insights
Diagnosing cytomegalovirus (CMV) infection is challenging. The IMMULITE 2000 CMV IgM assay accurately detects CMV IgM antibodies, aiding in diagnosing current or recent CMV infections in various patient groups.
Area of Science:
- Clinical Diagnostics
- Immunology
- Virology
Background:
- Cytomegalovirus (CMV) infection diagnosis is difficult due to asymptomatic cases and non-specific symptoms.
- Laboratory testing is crucial for accurate CMV diagnosis.
- Detecting CMV IgM antibodies indicates primary CMV infection, vital for pregnant women and immunocompromised individuals.
Purpose of the Study:
- To evaluate the performance of the IMMULITE 2000 CMV IgM assay for diagnosing CMV infection.
- To assess the assay's reproducibility, normal range, and method comparison against a predicate assay.
- To determine the assay's utility in diverse patient populations, including pregnant and immunocompromised individuals.
Main Methods:
- Qualitative detection of CMV IgM antibodies in serum or plasma using the IMMULITE 2000 CMV IgM assay.
- Reproducibility testing across three sites.
- Method comparison study involving 718 patient samples, including CMV IgM-positive, pregnant, HIV-positive, immunosuppressed, transplant patients, and those with cross-reacting conditions.
Main Results:
- The IMMULITE 2000 CMV IgM assay showed excellent reproducibility (total CV < 10%).
- High overall agreement (>95%) was observed when compared to the VIDAS CMV IgM assay across various patient groups.
- Agreements were approximately 96% for cross-reactive samples, 96% for immunocompromised, and 97% for pregnant subjects.
Conclusions:
- The IMMULITE 2000 CMV IgM assay is a reliable tool for diagnosing acute or recent CMV infections.
- The assay demonstrates excellent reproducibility and minimal cross-reactivity.
- Its performance is comparable to the VIDAS CMV IgM assay, making it suitable for clinical use.
Background:
Diagnosis 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.
Methods:
The 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.
Results:
The 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.
Conclusions:
The 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.
