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Published on: July 9, 2014
Evaluation of a rapid and convenient method for determination of cytomegalovirus immunoglobulin M
Jiajun Zhang1, Junchuan Li, Youshan Zhang
1First Affiliated Hospital of Yangtze University, Jingzhou HuBei, China.
Insights
Chemiluminescence immunoassay (CLIA) offers a highly sensitive and specific method for detecting human cytomegalovirus (hCMV) IgM. This advanced technique shows significant clinical value in diagnosing infectious mononucleosis.
Area of Science:
- Clinical diagnostics
- Immunology
- Virology
Background:
- Human cytomegalovirus (hCMV) is a common pathogen.
- Accurate detection of hCMV immunoglobulin M (IgM) is crucial for diagnosing primary infections like infectious mononucleosis.
- Existing diagnostic methods may have limitations in sensitivity or specificity.
Purpose of the Study:
- To evaluate a chemiluminescence immunoassay (CLIA) for determining hCMV IgM.
- To analyze the clinical utility of the CLIA method in patients with infectious mononucleosis.
- To compare the performance of CLIA with enzyme-linked immunosorbent assay (ELISA).
Main Methods:
- Serum samples from 407 participants were analyzed using an automatic CLIA analyzer.
- Samples were simultaneously tested using ELISA for comparative analysis.
- Technological quality, including sensitivity, functional sensitivity, imprecision, recovery, and correlation, was assessed.
Main Results:
- CLIA demonstrated high sensitivity (1.0 AU/mL) and functional sensitivity (<1.6 AU/mL).
- Within- and between-assay imprecision were below 5%, with recoveries between 96-110%.
- CLIA showed excellent correlation with expected values (R=0.9991) and superior diagnostic accuracy (AUC=0.990) compared to ELISA, with sensitivity and specificity exceeding 90%.
Conclusions:
- CLIA is a highly accurate and reliable method for measuring hCMV IgM.
- The CLIA method exhibits significant clinical value for diagnosing hCMV infections, including infectious mononucleosis.
- CLIA offers advantages over ELISA, potentially improving diagnostic capabilities.
Abstract:
We evaluated a method for determination of human cytomegalovirus (hCMV) immunoglobulin M (IgM) by CLIA, and analyzed its clinical value in patients with infectious mononucleosis. Serum samples from 407 participants were measured on an automatic CLIA analyzer. At the same time the serum samples were measured by enzyme-linked immunosorbent assay (ELISA). An assessment of technological quality (methodology) in diagnostic tests demonstrated that the sensitivity of CLIA was 1.0 AU/mL and the functional sensitivity was <1.6 AU/mL. The within- and between-assay imprecision values for different concentrations were all under 5%. Recoveries for both methods were 96-110%. The linear regression equation between expected values and measured values was y=0.644+0.986x, and correlation coefficient was 0.9991 (P<0.0001). The receiver operating characteristic (ROC) curve showed that both the sensitivity and specificity of CLIA surpassed 90%. The area under the curve (AUC) was 0.990, which was significantly higher than that of ELISA (P<0.05). The results indicate that CLIA is an excellent method for hCMV IgM measurement, and thus may be useful for clinical diagnoses.
