The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures

To the Editor,

Method evaluation is an essential activity to characterise the analytical performance of a laboratory method before routine clinical implementation. Data obtained from method evaluation can inform many aspects of laboratory practice, including implementing appropriate quality systems to ensure the laboratory method conforms to clinical requirements. However, method evaluation is performed heterogeneously in clinical laboratories. Method evaluation data may be reported in peer-reviewed literature when describing an existing or novel laboratory method, or when reporting the findings of method evaluation or comparison studies. However, reporting method evaluation data is often challenged by insufficient information, such as laboratory method, materials used, statistical analysis and acceptance limits/performance criteria selected, and the rationale for their selection. This lack of information can impede the reproducibility, accuracy, appropriate interpretation, and application of the evidence base reported in the literature and may hamper efforts to aggregate published data such as meta-analysis...