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Multicenter Interlaboratory Study of Thrombin Generation Assay in Healthy Adults Using the ST Genesia Analyzer With the STG-ThromboScreen Reagent (With and Without Thrombomodulin)

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Velasco-Rodríguez D.
  • Marcos-Jubilar M.
  • Martínez-Alfonzo I.
  • Martos L.
  • Aguilar C.
  • Vilalta N.
  • Llobet D.
  • Marco-Rico A.
  • Aragoneses D.
  • Marco P.
  • Ricca L.
  • Ferreira D.
  • Lopes S.
  • Mariano-Pego J.
  • Bernardo Á.
  • Gassiot S.
  • Gutiérrez-Jomarrón I.
  • Páramo J.A.
  • Llamas-Sillero P.
  • Reverter J.C.

Grupos

Abstract

Introduction: Fully automated thrombin generation (TG) assays facilitate the transition from research to clinical application. We conducted a multicenter inter-laboratory study using the ST Genesia analyzer to evaluate assay performance and establish reference intervals in healthy adults from Spain and Portugal. Methods: In this multicenter study, plasma samples from healthy adult volunteers were analyzed across 12 laboratories following a harmonized protocol. TG was measured using the STG-ThromboScreen reagent in the presence and absence of thrombomodulin (TM). Analytical performance and reference intervals were assessed. Results: Within-run and intra-day precision were excellent (coefficient of variation < 10%) for all TG parameters except velocity index. Normalization reduced interlaboratory variability for amplitude-based parameters such as endogenous thrombin potential (ETP) and peak height, whereas its effect was less pronounced for velocity index. Satisfactory interlaboratory performance (|z| = 2) was achieved in 96%–98% of results, and normalized parameters showed minimal bias across centers. In 252 healthy adults, median normalized values were: ETP 131% (IQR 118–142), peak height 116% (IQR 104–127), lag time 2.6 min (IQR 2.3–2.8), and time-to-peak 5.5 min (IQR 5.0–5.9). Median ETP inhibition in the presence of TM was 47.2% (IQR 35.1–61.8). Age had a modest influence on TG parameters, whereas sex differences were observed. Conclusions: This multicenter interlaboratory study in the Iberian Peninsula demonstrates high reproducibility of TG measurement using the ST Genesia platform with the STG-ThromboScreen reagent. These findings support its use for standardized TG assessment and provide reference intervals for clinical and research settings. © 2026 The Author(s). International Journal of Laboratory Hematology published by John Wiley & Sons Ltd.

Datos de la publicación

ISSN/ISSNe:
0141-9854, 1751-5521

CLINICAL AND LABORATORY HAEMATOLOGY  WILEY-BLACKWELL PUBLISHING, INC

Tipo:
Article
Páginas:
-
PubMed:
42264461
Enlace a otro recurso:
www.scopus.com
Cuartil:
Q2 SCImago ℠

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Keywords

  • automated; interlaboratory; multicenter; thrombin generation

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