Research and analysis

False positive treponemal (syphilis) IgM enzyme immunoassay results: adverse incident report

This report outlines the investigation by the former Health Protection Agency into false test results from a commercial syphilis IgM test kit.

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This report provides a full update report of investigations into the increase in false positive syphilis IgM results at 8 UK laboratories arising from 3 faulty batches of a particular brand of treponemal IgM EIA kit (the Mercia Syphilis M kit manufactured by Microgen Bioproducts) which led to a small number of individuals being incorrectly diagnosed with syphilis, or incorrectly treated for an earlier stage of infection.