Ann Lab Med.  2024 Mar;44(2):122-125. 10.3343/alm.2023.0342.

The LEAP Checklist for Laboratory Evaluation and Analytical Performance Characteristics Reporting of Clinical Measurement Procedures

• Loh TP
• Cooke BR
• Mai Tran TC
• Markus C
• Zakaria R
• Ho CS
• Theodorsson E
• Greaves RF
• botIWGoMEP(M

• KMID: 2553375
• DOI: http://doi.org/10.3343/alm.2023.0342

Abstract

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

Keyword

Checklist; Emerging technology; International Federation of Clinical Chemistry and Laboratory Medicine; Method; Protocol; Validation; Verification

Reference

1. Rifai N, Annesley TM, Berg JP, Brugnara C, Delvin E, Lamb EJ, et al. 2012; An Appeal to Medical Journal Editors: The Need for a Full Description of Laboratory Methods and Specimen Handling in Clinical Study Reports. Scand J Clin Lab Invest. 72:89–91. DOI: 10.3109/00365513.2011.654052. PMID: 22339367. PMCID: PMC3357892.

2. Hand M, Crampton A, Thomas A, Kilpatrick ES. 2019; A survey of clinical laboratory instrument verification in the UK and New Zealand. Ann Clin Biochem. 56:275–82. DOI: 10.1177/0004563218823804. PMID: 30674211.

3. UK EQUATOR Centre. How to Develop a Reporting Guideline. Available at: https://www.equator-network.org/toolkits/developing-a-reporting-guideline/. Accessed: 18th July 2023.

4. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015; 351:h5527. DOI: 10.1136/bmj.h5527. PMID: 26511519. PMCID: PMC4623764.

5. Greaves R, Kricka L, Gruson D, Ferrari M, Martin H, Loh TP, et al. Toolkit for emerging technologies in laboratory medicine. Clin Chem Lab Med. 2023; DOI: 10.1515/cclm-2023-0571. PMID: 37314970.

6. Monaghan PJ, Robinson S, Rajdl D, Bossuyt PMM, Sandberg S, St John A, et al. 2018; Practical guide for identifying unmet clinical needs for biomarkers. EJIFCC. 29:129–37.

7. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed: 2022.

8. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. 2015; Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med. 53:833–5. DOI: 10.1515/cclm-2015-0067. PMID: 25719329.