Authors' objectives: 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).

Authors' recommendations: Overall, all the data collected and analysed are consistent and support the proposal of modification put forward by UNCAM and CNR-Syphilis. HAS therefore recommends this proposal of modification of the Nomenclature of Procedures in Laboratory Medicine consisting of changing the algorithm in force by immediately replacing the systematic combination of a TT and an NTT with a single total Ig TT using a method that can be reproduced and automated, of an immunoenzymatic type (ELISA technique or related ones such as the EIA or the CMIA), which will be confirmed by a quantitative NTT in the event of positivity.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.has-sante.fr/portail/upload/docs/application/pdf/2015-05/argumentaire_syphilis_vd.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr