Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Topics

UsernamePublicRestriction

Register

MT060260

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel