Complementarity between Bayesian Internal Quality Control results management and External Quality Assessment bivariate z-score analysis: application to a concrete case study.

It is important that a clinical laboratory has implemented appropriate procedures for quality control, which includes both internal quality control (IQC) and external quality assessment (EQA) with the common goal to detect systematic errors and random errors. It is the case for both the Hemohub® Bayesian tools for IQC results interpretation and the ECAT EQA optimised bivariate z-scores analysis. On a concrete case study, we demonstrate both the higher sensitivity and specificity of optimised bivariate z-scores analysis than the univariate approach.

Comparison of one-stage and chromogenic factor VIII assays to tailor the dose of recombinant factor VIII-Fc fusion protein (rFVIIIFc, efmoroctocog alfa) in adult patients with haemophilia A: Single-centre, real-world experience of surgery.

Background: Efmoroctocog alfa (rFVIIIFc) is an extended half-life FVIII used notably in surgery for patients with haemophilia A. More information is needed of its usage in real-life.

Methods: Adult patients with HA followed at the Lyon Comprehensive Hemophilia Care Center who underwent a surgery with rFVIIIFc were included in this retrospective analysis.

[Long-term automated Bayesian management of IQC results: The experience of the Lyon Hospitals Board hemostasis laboratory].

The Lyon Hospitals Board (HCL) hemostasis laboratory has shifted from a frequentist to a long-term Bayesian approach to IQC results management, using the Hemohub® software of the Werfen corporation, which hosts the requisite Bayesian tools. IQC plans based on supplier specifications proved effective in managing analytic risk in line with the ISO 15189 standard. Long-term Hemohub® control and monitoring has been validated by acceptable feedback from the EQA organization used by the hemostasis community.

Cost-effectiveness of thrombotic thrombocytopenic purpura diagnosis: a retrospective analysis in the University Hospital Center of Lyon (France).

The aim of the present study was to perform an economic evaluation of two alternative assays of ADAMTS13 activity (A Disintegrin And Metalloprotease with ThromboSpondin type 1 repeats, member 13) for diagnosing thrombotic thrombocytopenic purpura (TTP) in the Hospital of Lyon (France). The study approach was more economic than clinical. We retrospectively calculated the prescription costs of ADAMST13 activity from January to December 2019 for patients depending on the assay: manual ELISA (Technozym) or automated assay (AcuStar Werfen, Instrumentation Laboratory).

Prospective evaluation of two specific IgG immunoassays (HemosIL AcuStar HIT-IgG and HAT45G ) for the diagnosis of heparin-induced thrombocytopenia: A Bayesian approach.

Introduction: The accurate diagnosis of heparin-induced thrombocytopenia (HIT) is essential to ensure adequate treatment and prevent complications. First step diagnosis test are immunoassays including enzyme-linked immunosorbent assays (ELISAs) and rapid immunoassays.

Methods: Using a Bayesian approach, we prospectively evaluated the performance of the IgG PF4/polyvinylsulfonate ELISA and a chemiluminescent immunoassay (CLIA), which are specific for IgG and use the same antigenic target to detect HIT antibodies.

[Theoretic and practical contribution of bayesian inference to statistical process control: The experience of the Lyon Hospitals Board hemostasis laboratory].

Laboratories need to set up effective overall management of their internal quality control (IQC) and external quality assessment (EQA) results as key elements in statistical process control. Quality targets need to be defined, with methods to ensure durable control with respect to the relevant specifications. The hemostasis laboratory of the Lyon Hospitals Board (HCL, Lyon, France) uses model 3 from the Milan consensus conference, which is the state of the art in terms of quality targets, and uses a common EQA provider supplying as many real patient samples as possible.

Effects of hemolysis, bilirubin, and lipemia interference on coagulation tests detected by two analytical systems.

Introduction: Interference on biological assays due to hemolysis, icterus, or lipemia (HIL) could represent a significant source of analytical errors leading to inaccurate interpretation of results. The aim of this study was to assess the HIL interference on prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen, using mechanical and optical detection methods.

Methods: Control plasmas and plasmas from patients treated with vitamin K antagonists or unfractionated heparin, with or without HIL, were performed on two analytical detection systems in order to identify potential analytical biases.