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Published on: April 20, 2011
Evaluation of 4 commercial test kits for parvovirus B19-specific IgM
1Enteric and Respiratory Virus Laboratory, Central Public Health Laboratory, London, UK.
Insights
Commercial parvovirus B19 IgM test kits show variable performance. Sensitivity and specificity differ across clinical settings, impacting accurate diagnosis of acute B19 infection.
Area of Science:
- Virology
- Immunology
- Diagnostic Assays
Background:
- Parvovirus B19 infection presents with diverse clinical manifestations.
- Accurate diagnosis of acute parvovirus B19 infection is crucial for patient management.
- Commercial IgM test kits are widely used for diagnosing B19 infection.
Purpose of the Study:
- To evaluate the sensitivity and specificity of four commercial parvovirus B19 IgM test kits.
- To assess assay performance across various clinical scenarios.
- To determine the utility of these kits in diagnosing acute B19 infection.
Main Methods:
- Evaluation of four commercial parvovirus B19 IgM test kits.
- Testing of 491 human serum samples across seven distinct panels.
- Comparison with a reference mu-capture radioimmunoassay (MACRIA).
Main Results:
- Overall sensitivity ranged from 70.1% to 84.1%; specificity from 92.2% to 97.4% compared to MACRIA.
- 100% sensitivity was observed in adults with B19 arthropathy.
- Sensitivity was lower in children with fifth disease (44.1-88.6%), late-stage samples (>6 weeks), and B19-associated embryopathy.
- Specificity varied significantly (70.9-83.3%) in patients with other viral infections.
Conclusions:
- Commercial B19 IgM assays demonstrate variable performance depending on the clinical context.
- Sensitivity is compromised in specific patient groups and sample timings.
- Specificity can be affected by concurrent viral infections.
- Understanding assay limitations is essential for accurate interpretation of B19 IgM test results.
Abstract:
Four commercial test kits for parvovirus B19 IgM were evaluated by testing 491 sera assembled into 7 panels. The serum panels were designed to assess sensitivity and specificity of the commercial assays and to reflect the various clinical settings in which acute B19 infection forms part of the differential diagnosis. A mu-capture radioimmunoassay (MACRIA) was used as the reference test. With respect to MACRIA, the commercial B19 IgM assays showed an overall sensitivity of 70.1-84.1% and specificity of 92.2 to 97.4%. Assay performance varied in different clinical situations. In sera from adults with acute B19 arthropathy, all 4 assays were 100% sensitive, but in children with fifth disease, the sensitivity ranged from 44.1 to 88.6%. The sensitivity of all 4 assays was also low when testing samples collected more than 6 weeks after onset of symptoms and in women with B19-associated embryopathy. Specificity was greater than 97% in healthy blood donors, but varied from 70.9 to 83.3% in patients acutely infected with other viruses, including rubella. Although the IgM test kits here evaluated may be usefully introduced for B19 diagnosis in certain settings, knowledge of their limitations will be important when results have been interpreted.
