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Syphilis kits go under MHRA's (Medicines and Healthcare products Regulatory Agency) evaluation spotlight

This article was originally published in Clinica

Executive Summary

Ten syphilis EIAs feature in the second bacteriology kit evaluation report published this year by the Device Evaluation Service (DES) of the UK's Medicines and Healthcare products Regulatory Agency (MHRA). These assays are: Abbott Murex ICE Syphilis; Biokit Bioelisa Syphilis 3.0; biomerieux Trepanostika TP Recombinant; Bio-Rad Syphilis Total; Dade Behring Enzygnost Syphilis; Diesse Enzywell Syphilis; Microgen Bioproducts Mercia Syphilis; Newmarket Laboratories Syphilis EIA II; Omega Pathozyme Syphilis Competition; and Trinity Biotech Captia Syphilis. The report provides a description of the assays, a technical appraisal and details of specificity and sensitivity.





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