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Sensitivity and specificity of mu-capture ELISA for detection of enterovirus IgM
1Public Health Laboratory, West Park Hospital, Epsom, Surrey, UK.
Abstract:
The sensitivity and specificity of an in-house mu-capture enzyme linked immunosorbent assay (ELISA) for enterovirus IgM in routine use was determined by analysing the results of 77 serum samples from 55 enterovirus culture-positive patients with aseptic meningitis and single serum samples from 140 patients with other infections. In addition, sera from 10 laboratory staff pre- and post-polio virus vaccination and 20 rheumatoid factor positive sera were tested for specificity. On testing the first serum specimen received, only 21 of 55 patients (38%) with aseptic meningitis yielded a positive result, rising to 33 of 55 (60%) on testing a second sample, where available. Out of 14 patients from whom multiple serum samples were tested and negative results obtained with the first serum, 12 were positive with the second sample (86%). Only patients with acute hepatitis A produced a significant number of false positives by the enterovirus ELISA (12 out of 20), but the reverse was not true: patients with enterovirus IgM did not produce false positive results in tests for hepatitis A IgM. Excluding samples positive for hepatitis A IgM, the number of non-enterovirus infections correctly reported as negative was 118 out of 120--a specificity of 98%. This test is probably the most useful serological test available at present for diagnosing recent enterovirus infection, although the limited sensitivity needs to be borne in mind.
Insights
This study evaluated an in-house enzyme-linked immunosorbent assay (ELISA) for detecting enterovirus IgM. While specific, its sensitivity is limited, requiring paired samples for better enterovirus diagnosis.
Area of Science:
- Virology
- Immunology
- Diagnostic Assay Development
Background:
- Enteroviruses are significant causes of aseptic meningitis.
- Accurate and timely diagnosis of enterovirus infections is crucial for patient management.
- Serological assays, like ELISA, are valuable tools for diagnosing viral infections.
Purpose of the Study:
- To determine the sensitivity and specificity of an in-house mu-capture enzyme-linked immunosorbent assay (ELISA) for detecting enterovirus IgM.
- To assess the utility of this ELISA in routine clinical diagnostics for aseptic meningitis.
- To evaluate potential cross-reactivity with other infections and conditions.
Main Methods:
- Analysis of 77 serum samples from enterovirus-positive patients with aseptic meningitis.
- Testing of 140 serum samples from patients with other infections.
- Evaluation of specificity using sera from laboratory staff and patients with rheumatoid factor and acute hepatitis A.
Main Results:
- The ELISA showed limited sensitivity (38% with first sample, 60% with second).
- Sensitivity increased to 86% when using paired serum samples.
- High specificity (98%) was observed, with minimal false positives, primarily from acute hepatitis A infections.
Conclusions:
- The in-house enterovirus IgM ELISA is a specific diagnostic tool.
- Limited sensitivity necessitates the use of paired samples for improved enterovirus detection.
- Despite sensitivity limitations, it remains a useful serological test for recent enterovirus infections.

