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OPINIONI - Opinions

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Biochimica Clinica 2012; 36(3) 193-195

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Autenticazione richiesta

Necessità di una descrizione completa dei metodi di laboratorio e del trattamento del campione nella pubblicazione di studi clinici: un appello agli editori di riviste mediche

AUTORI

Nader Rifai, Thomas M. Annesley, Jens P. Berg, Carlo Brugnara, Edgard Delvin, Edmund J. Lamb, Paul M. Ness, Mario Plebani, Mark R. Wick, Alan Wu, Joris Delanghe

ABSTRACT

An appeal to medical journal editors: the need for a full description of laboratory methods and specimen handling in clinical study reports.

As editors of the laboratory medicine journals we urge the medical journal editors to adopt and enforce the following requirements for clinical studies that include laboratory testing for biomarkers: 1) for commercial diagnostic tests, authors must include the actual name and generation of assay, the manufacturer and the instrument used for analyses; 2) authors must report performance characteristics, such as the imprecision of the assay in the investigators’ laboratories, the assay’s reportable range, and any reference interval used in the study; 3) authors must clearly indicate the types of specimens analyzed and the storage conditions for these specimens.

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