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Table. 1.

Table. 1.

Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist

Item No. Recommendation Page No.
Title 1 Indicate whether the study involves:
a. Method verification of an established commercial measurement procedure, or
b. Method validation of a modified/ novel measurement procedure or a laboratory-developed test.
Abstract 2 a. Indicate the key performance characteristics studied.
b. Provide numerical absolute and relative results of performance characteristics such as imprecision, bias, and linearity instead of qualitative statements.
Introduction 3 a. For novel technology or measurement procedure, indicate the clinical need it is addressing and the clinical pathway within which it is applied [5, 6].
b. For existing/commercial technology or measurement procedure, indicate the intended clinical context (e.g., clinical condition, population, clinical pathway) within which the technology or measurement procedure will be applied.
Method Section
Ethics 4 a. If patient samples or data are being used in the study, indicate whether ethics approval has been sought, or if appropriate, indicate the reason for the waiver. Compliance with the WMA Declaration of Helsinki should be indicated, where relevant [7].
Technology/ measurement procedure 5 a. Describe the technology and/or measurement procedure used to produce the laboratory results in sufficient detail (i.e. including hardware, calibrator/reagent, procedure/protocol, consumables, and software) to allow independent replication of the results.
b. Describe the matrix of the material used and, where relevant, the purity of the materials (e.g. solvent and standards) used.
c. Detail the traceability hierarchy of the higher order reference materials used and its measurement uncertainty if such information is available.
d. Indicate whether the technology or measurement procedure has received regulatory approval for clinical use, or whether it is limited for research-use only.
Materials used 6 a. Describe the material used for each analytical performance component in the study (e.g., patient sample, quality control material, external quality assurance material or commercial material), the sample matrix, and if known, the commutability and traceability of the material (demonstrated or otherwise).
b. Describe the concentration of the materials used and provide clinical justification for their selection.
c. Describe any alteration (e.g. dilution, spiking of material) of the sample, where relevant.
d. Describe the stability and storage conditions of the material if relevant.
Experimental designs 7 a. The components of analytical performance evaluation include repeatability and reproducibility imprecision, bias, linearity, analytical measurement interval, clinically reportable interval, dilution factor, limits of quantitation, interference study, method comparison, carryover and stability. Noting the components of the method evaluation varies depending on whether validation or only verification is required.
b. Describe the number of replicates, runs and days (particularly for precision studies) over which the evaluation was performed.
c. Describe the experimental procedures, including storage conditions and sample preparation, used for each evaluation component.
Analytical performance specification 8 a. Define a priori analytical performance specifications (i.e. acceptance/rejection criteria) for each of the evaluation components with a clear rationale following the Milan consensus [8].
Statistical analysis 9 a. Describe the statistical analysis performed to assess each component of the analytical performance characteristics.
b. For statistical analysis involving linear regression, statistical models that are robust regarding heteroscedasticity are preferred.
c. Of note, regression characteristics, including slope, intercept, coefficient of coefficient, r, and correlation of determination, R2, are not properties of linearity and should not be reported in this context.
Results Section
Analytical performance characteristics 10 a. Summarise the findings for each evaluation component as stated method section.
b. Provide an appropriate numerical summary for the performance characteristics.
c. Provide confidence intervals and/or P-value if formal statistical testing was performed.
d. Use the appropriate significant figures when reporting the data.
e. Provide data on proficiency testing performance, especially quantitative data on bias.
Outlier results 11 a. Describe the methods used for detecting outliers, detail number of outliers detected in the study, and whether they were excluded with or without replacement.
b. Provide possible reasons for the outlier results that are not due to gross blunders to improve understanding of the measurement procedure.
Discussion
Interpretation 12 a. Interpret the findings of the evaluation study conservatively in the clinical context where the technology or measurement procedure will be applied.
b. Compare the findings of the evaluation study against the a priori-defined analytical performance specification and discuss whether it is fit for purpose.
Limitations 13 a. Report and discuss any relevant limitations in the study design that may influence/restrict/bias the findings.
b. Discuss any analytical limitations uncovered during the evaluation study.
Generalisability 14 a. Discuss the findings of the study in the context of existing literature (e.g., other studies or incumbent technology/measurement procedures).
Ann Lab Med 2024;44:122~125 https://doi.org/10.3343/alm.2023.0342

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