PB1061 - Multicentre Performance Evaluation and Reference Range for an Immunoassay for the Quantitative Determination of Factor XIII Antigen on the cobas t 711 Analyser

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Martin Büchsel, MD

Physician
University Medical Center Freiburg, Faculty of Medicine, University of Freiburg
Freiburg, Baden-Wurttemberg, Germany

Co-Author(s)

JC

Jessica Creaghan

Specialist Biomedical Scientist
Sheffield Haemostasis and Thrombosis Centre
Sheffield, England, United Kingdom
UG

Ulrich Geisen

MD
Institute for Clinical Chemistry and Laboratory Medicine, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg
Freiburg, Baden-Wurttemberg, Germany
PJ

Petra Jilma

MD
Department of Laboratory Medicine, Medical University of Vienna
Vienna, Wien, Austria
RJ

Robert Jones

Senior Biomedical Scientist/Study Investigator
Sheffield Haemostasis and Thrombosis Centre
Sheffield, England, United Kingdom
Steve Kitchen, PhD

Lead Scientist
Sheffield Haemophilia and Thrombosis Centre
sheffield, England, United Kingdom
GR

Gergely Rozsnyai

Senior Study Manager
Roche Diagnostics International Ltd
Rotkreuz, Zug, Switzerland
PQ

Peter Quehenberger

Professor
Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria
Vienna, Wien, Austria

Background: Factor XIII (FXIII) is a protransglutaminase important in the final stage of blood coagulation and is vital in stabilising the haemostatic plug. FXIII deficiency is a rare bleeding disorder characterised by abnormal blood clotting. A multicentre evaluation of an immunoassay for the quantitative determination of FXIII antigen (subunit A) was performed.

Aims: Evaluate analytical performance of the FXIII immunoassay on the high-throughput cobas t 711 analyser (Roche Diagnostics International Ltd, Rotkreuz, Switzerland).

Methods: Analytical performance was assessed at three sites (Freiburg, Sheffield, Vienna; April–August 2021) using 3.2% citrated, anonymised, ethically approved, residual routine plasma samples. Five human plasma pools and two controls were used to measure assay repeatability (one run/site; n=21 replicates/sample), intermediate precision and total reproducibility (five aliquots/sample/day over five days); standard deviations (SDs) and coefficients of variation (CVs) were calculated. Using three sets of ≥120 samples covering the measuring range of the assay, method comparison (versus HemosIL Factor XIII Antigen on IL/Werfen ACL TOP 700 analyser) and lot-to-lot variability (three reagent lots) were evaluated by Deming and Passing-Bablok regression, respectively, and Pearson’s r calculated. The reference range was determined in fresh samples from healthy adults not receiving anticoagulants (Freiburg only; n=200; three reagent lots).

Results: Across sites, the FXIII immunoassay met the acceptance criteria for repeatability (SD, 0.112–0.270; CV, 0.7–2.8%), intermediate precision (SD, 0.150–0.676; CV, 0.9–4.2%) and total reproducibility (CV, 3.3–9.9%). The FXIII immunoassay showed agreement with the comparator assay (Pearson’s r, 0.892–0.918; Table 1) and good lot-to-lot variability (Pearson’s r, 0.990–0.993; Table 2). The reference range of the FXIII immunoassay in healthy individuals was 68.0–159 IU/dL.

Conclusion(s): The FXIII immunoassay showed robust analytical performance on the cobas t 711 analyser, supporting its use in routine clinical laboratory practice.

Study

Funding: Roche Diagnostics International Ltd, Rotkreuz, Switzerland.