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Health technology assessment

Modification of the Nomenclature of Procedures in Laboratory Medicine for the procedure for therapeutic monitoring of patients infected with Treponema pallidum (bacterium responsible for syphilis) - INAHTA Brief

Date of validation
March 2017

This concerns a request from the Union nationale des caisses d’assurance maladie (UNCAM) [Association of Health Insurance Funds] sent in June 2014 and included in the 2015 HAS work programme. UNCAM wishes to modify the Nomenclature of Procedures in Laboratory Medicine (NABM) for research into Treponema pallidum (bacteria responsible for syphilis).

A new algorithm replacing the current algorithm was proposed by UNCAM together with CNR-Syphilis [Centre National de Référence de la Syphilis - National Syphilis Reference Centre].

The algorithm currently in force in the Nomenclature of Procedures in Laboratory Medicine requires the completion of a treponemal test (TT) and a non treponemal test (NTT) as part of a screening process. They are manual tests and are a tedious job.

The algorithm proposed in the request aims primarily to replace the systematic combination of a TT and a NTT with a single treponemal total Ig test using a method that can be reproduced and automated; it uses ELISA (Enzyme-Linked ImmunoSorbent Assay) techniques or related ones such as the EIA (Enzyme ImmunoAssays) or the CMIA (Chemiluminescent Magnetic microparticle ImmunoAssay); these tests, as well as being very sensitive, have a number of practical advantages related to automation.

The concern of the request was therefore to ensure that the proposed change was not going to cause a decline in quality in detection that would lead to disregarding cases of infected patients (appearance of false negatives based on a single automated TT)

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Posted on Mar 28 2017