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Gomez-Rioja R.

Department of Laboratory Medicine, La Paz-Carlos III-Cantoblanco University Hospital, Paseo de la Castellana 261

Von Meyer A.

Institute for Laboratory Medicine and Microbiology Munich Municipal Clinic Group

Cornes M.

Biochemistry Department, Worcestershire Acute Hospitals NHS Trust, Worcester Royal Hospital

Costelloe S.

Department of Clinical Biochemistry, Cork University Hospital Group

Vermeersch P.

Department of Laboratory Medicine, KU Leuven University Hospitals Leuven

Simundic A-M.

Department of Medical Laboratory Diagnostics, University Hospital Sveti Duh

Nybo M.

Clinical Biochemistry and Pharmacology, Odense Universitetshospital

Baird G.S.

Department of Laboratory Medicine, University of Washington, Seattle

Kristensen G.B.

Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital

Cadamuro J.

Department of Laboratory Medicine, Paracelsus Medical University Salzburg

Recommendation for the design of stability studies on clinical specimens

Authors:

Gomez-Rioja R., Von Meyer A., Cornes M., Costelloe S., Vermeersch P., Simundic A-M., Nybo M., Baird G.S., Kristensen G.B., Cadamuro J.

More about the authors

Journal: Laboratory Service. 2023;12(3): 61‑72

DOI: 10.17116/labs20231203161

Read: 1773 times

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Table of contents

RECOMMENDATION FOR THE DESIGN OF STABILITY STUDIES ON CLINICAL SPECIMENS
RECOMMENDATION FOR THE DESIGN OF STABILITY STUDIES ON CLINICAL SPECIMENS

To cite this article:

Gomez-Rioja R, Von Meyer A, Cornes M, et al. Recommendation for the design of stability studies on clinical specimens. Laboratory Service. 2023;12(3):61‑72. (In Russ.)
https://doi.org/10.17116/labs20231203161

Подписка 2025 Лабораторная служба (Laboratory Service)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

OBJECTIVES

Knowledge of the stability of analytes in clinical specimens is a prerequisite for proper transport and preservation of samples to avoid laboratory errors. The new version of ISO 15189:2022 and the European directive 2017/746 increase the requirements on this topic for manufacturers and laboratories. Within the project to generate a stability database of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Preanalytical Phase (WG-PRE), the need to standardise and improve the quality of published stability studies has been detected, being a manifest deficit the absence of international guidelines for the performance of stability studies on clinical specimens.

METHODS

These recommendations have been developed and summarised by consensus of the WG-PRE and are intended primarily to improve the quality of sample stability claims included in information for users provided by assay supplier companies, according to the requirements of the new European regulations and standards for accreditation.

RESULTS

This document provides general recommendations for the performance of stability studies, oriented to the estimation of instability equations in the usual working conditions, allowing flexible adaptation of the maximum permissible error specifications to obtain stability limits adapted to the intended use.

CONCLUSIONS

We present this recommendation based on the opinions of the EFLM WG-PRE group for the standardisation and improvement of stability studies, with the intention to improve the quality of the studies and the transferability of their results to laboratories.

Keywords:

instability equation
preanalytical phase
sample stability

Authors:

Gomez-Rioja R.

Department of Laboratory Medicine, La Paz-Carlos III-Cantoblanco University Hospital, Paseo de la Castellana 261

Von Meyer A.

Institute for Laboratory Medicine and Microbiology Munich Municipal Clinic Group

Cornes M.

Biochemistry Department, Worcestershire Acute Hospitals NHS Trust, Worcester Royal Hospital

Costelloe S.

Department of Clinical Biochemistry, Cork University Hospital Group

Vermeersch P.

Department of Laboratory Medicine, KU Leuven University Hospitals Leuven

Simundic A-M.

Department of Medical Laboratory Diagnostics, University Hospital Sveti Duh

Nybo M.

Clinical Biochemistry and Pharmacology, Odense Universitetshospital

Baird G.S.

Department of Laboratory Medicine, University of Washington, Seattle

Kristensen G.B.

Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital

Cadamuro J.

Department of Laboratory Medicine, Paracelsus Medical University Salzburg

Received:

16.08.2023

Accepted:

17.09.2023

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