Reply to "Better method for evaluating a new laboratory test for syphilis"

Affiliations

¹ Laboratory of G. Enders & Colleagues, MZV and Institute of Virology, Infectious Diseases and Epidemiology e. V., Stuttgart, Germany.
² Labor Schottdorf MZV GmbH, Augsburg, Germany.
³ Central Institute for Blood Transfusion and Immunology, Innsbruck, Austria.
⁴ Thai Red Cross Society, Bangkok, Thailand.
⁵ Faculty of Medicine, Ege University, Smyrna, Turkey.
⁶ The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy.
⁷ The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy vittorio.sambri@unibo.it.

Comment

Martin Enders et al. Clin Vaccine Immunol. 2015 May.

. 2015 May;22(5):607-8.

doi: 10.1128/CVI.00109-15.

¹ Laboratory of G. Enders & Colleagues, MZV and Institute of Virology, Infectious Diseases and Epidemiology e. V., Stuttgart, Germany.
² Labor Schottdorf MZV GmbH, Augsburg, Germany.
³ Central Institute for Blood Transfusion and Immunology, Innsbruck, Austria.
⁴ Thai Red Cross Society, Bangkok, Thailand.
⁵ Faculty of Medicine, Ege University, Smyrna, Turkey.
⁶ The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy.
⁷ The Greater Romagna Area Hub Laboratory, Unit of Microbiology, Pievesestina, Cesena, Italy vittorio.sambri@unibo.it.

No abstract available

Comment on

Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum.
Enders M, Hunjet A, Gleich M, Imdahl R, Mühlbacher A, Schennach H, Chaiwong K, Sakuldamrongpanich T, Turhan A, Sertöz R, Wolf E, Mayer W, Tao C, Wang LL, Semprini S, Sambri V. Enders M, et al. Clin Vaccine Immunol. 2015 Jan;22(1):17-26. doi: 10.1128/CVI.00505-14. Epub 2014 Oct 29. Clin Vaccine Immunol. 2015. PMID: 25355799 Free PMC article.
Better method for evaluating a new laboratory test for syphilis.
Zhang Q, Zhang YF, Chen FY, Liu L, Yang TC, Niu JJ, Liu LL. Zhang Q, et al. Clin Vaccine Immunol. 2015 May;22(5):606. doi: 10.1128/CVI.00014-15. Clin Vaccine Immunol. 2015. PMID: 25921468 Free PMC article. No abstract available.

1. Zhang Q, Zhang Y-F, Chen F-Y, Liu L, Yang T-C, Niu J-J, Liu L-L. 2015. Better method for evaluating a new laboratory test for syphilis. Clin Vaccine Immunol 22:606. doi:10.1128/CVI.00014-15. - DOI - PMC - PubMed
1. Enders M, Hunjet A, Gleich M, Imdahl R, Mühlbacher A, Schennach H, Chaiwong K, Sakuldamrongpanich T, Turhan A, Sertöz R, Wolf E, Mayer W, Tao C, Wang LL, Semprini S, Sambri V. 2015. Performance evaluation of the Elecsys syphilis assay for the detection of total antibodies to Treponema pallidum. Clin Vaccine Immunol 22:17–26. doi:10.1128/CVI.00505-14. - DOI - PMC - PubMed
1. 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... Accessed 17 February 2015.
1. 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/GuidanceDo... Accessed 17 February 2015.