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

Abstract

We, the editors of the laboratory medicine journals, urge our colleagues in the International Committee of Medical Journal Editors (ICMJE)1 to adopt and enforce the following requirements for clinical studies that include laboratory testing for biomarkers, and to add these statements to the information for authors: 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 (normal) range used in the study. 3. Authors must clearly indicate the types of specimens analyzed and the storage conditions for these specimens. The rationale for these requirements is provided below. Biochemical markers (here referred to as biomarkers) are being used increasingly in the diagnosis, staging, and prognosis of various diseases, as well as in the monitoring of response and determination of compliance with prescribed treatment regimens. Although a biomarker initially is developed and approved by regulatory agencies for a particular clinical use, other potential clinical applications of that biomarker usually evolve over time (e.g., cardiac troponin, B-type natriuretic peptide, C-reactive protein). These new potential applications often require the manufacturer to develop a more analytically sensitive or specific assay to meet the new clinical needs. It is common to have multiple generations of assays for a particular biomarker in the marketplace concurrently (cardiac troponin, thyroid-stimulating hormone). With the recent wave of mergers and acquisitions in the in vitro diagnostics industry, a single manufacturer can have multiple platforms and may feel obligated to have a similar menu of testing on all of them. In many cases, the same reagents for a given biomarker measurement may end up being used on several instruments that yield different results. Standardization and harmonization studies …