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Consensus instability equations for routine coagulation tests

  • Rubén Gómez Rioja ORCID logo EMAIL logo , Andrea Caballero Garralda ORCID logo , Immaculada Comas Reixach ORCID logo , Carlos García Miralles ORCID logo , María Antonia Llopis Díaz ORCID logo , Débora Martínez Espartosa ORCID logo , Reyes Nicolás de Blas ORCID logo , Mariona Panadès Turró , Laura Puigví Fernández ORCID logo , Laura Rodelgo Jiménen ORCID logo , Berta Sufrate-Vergara ORCID logo , Emma Ventura Orriols and on behalf of the Spanish Society of Laboratory Medicine (SEQCML, SEMEDLAB) Extra-analytical Quality Committee
Published/Copyright: March 31, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 8

Abstract

Objectives

The stability of plasma samples for basic coagulation tests, prothrombin time (PT) and activated partial thromboplastin time (aPTT), has been widely studied. Recently, the Clinical and Laboratory Standards Institute (CLSI) updated its recommendations, extending the acceptable time frame for aPTT. These guidelines are based on experimental studies, which define limits according to different maximum permissible error (MPE) criteria. This study compiles raw data from 43 studies published over the last 30 years to develop a consensus instability equation that describes degradation independently of specific study parameters.

Methods

A critical literature review was performed by collecting studies that included experimental stability data for PT, aPTT and the main procoagulant factors. The raw data of percentage deviation (PD%), time, and seven classification variables related to sample collection and handling were analysed. A regression model through the origin was applied to derive global instability equations and to assess influencing variables.

Results

In frozen samples, PT and aPTT showed similar stability, with an average prolongation of 0.8 % per month. In non-frozen samples, tube handling affected stability more than storage temperature. The consensus equation for PT showed a linear average deterioration of 2.9 % per day, but model strength was limited. For aPTT, the consensus equation fitted better to a logarithmic decay model and predicted prolongations of 6.1 and 10 % at 6 and 24 h, respectively.

Conclusions

The consensus instability equations obtained in this review provide a robust model for assessing coagulation tests stability, aligning with expert recommendations. These equations improve the understanding of sample degradation and systematic error quantification.

Keywords: sample stability; preanalytical phase; stability equation; coagulation
Corresponding author: Rubén Gómez Rioja, Hematology Department, La Paz-Cantoblanco-Carlos III Hospital, Madrid, Spain, E-mail:

Acknowledgments

This document, on behalf of the Spanish Society of Laboratory Medicine (SEQCML, SEMEDLAB after 2024 December) Extra-analytical Quality Committee, has been presented, discussed, reviewed and approved at the plenary meetings of the group, whose current members are listed at the SEQC-SEMEDLAB site: https://www.seqc.es/es/comisiones/comision-de-calidad-extraanalitica/_id:5/.

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The data that support the findings of this study.

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Received: 2025-01-30
Accepted: 2025-03-09
Published Online: 2025-03-31
Published in Print: 2025-07-28

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0117
Keywords for this article
sample stability; preanalytical phase; stability equation; coagulation

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Setting analytical performance specification by simulation (Milan model 1b)
  4. Reviews
  5. Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis
  6. Clostebol detection after transdermal and transmucosal contact. A systematic review
  7. Opinion Papers
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  9. Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
  10. Perspectives
  11. Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
  12. Clinical vs. statistical significance: considerations for clinical laboratories
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  14. Reliable detection of sex chromosome abnormalities by quantitative fluorescence polymerase chain reaction
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  16. Candidate Reference Measurement Procedures and Materials
  17. Liquid chromatography tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure for urine albumin
  18. General Clinical Chemistry and Laboratory Medicine
  19. Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
  20. Exploring the extent of post-analytical errors, with a focus on transcription errors – an intervention within the VIPVIZA study
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