Reply to “Better Method for Evaluating a New Laboratory Test for Syphilis”

Author:

Enders Martin,Gleich Michael,Mühlbacher Annelies,Sakuldamrongpanich Tasanee,Turhan Ajda,Sertöz Rüchan,Semprini Simona,Sambri Vittorio

Publisher

American Society for Microbiology

Subject

Microbiology (medical),Clinical Biochemistry,Immunology,Immunology and Allergy

Reference4 articles.

1. Better method for evaluating a new laboratory test for syphilis;Clin Vaccine Immunol,2015

2. Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum;Clin Vaccine Immunol,2015

3. Official Journal of the European Union. 2009. Commission decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:318:0025:0040:EN:PDF. Accessed 17 February 2015.

4. U.S. Food and Drug Administration. Statistical guidance on reporting results from studies evaluating diagnostic tests (guidance for industry and FDA staff—version 13 March 2007). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071148.htm. Accessed 17 February 2015.

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