PB0101 - Evaluation of the new Stago system sthemO Anti-Xa M on sthemO 301 analyzer for monitoring heparin therapy.

Sunday, June 23, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

Joffrey Feriel, PharmD

Scientific manager
Diagnostica Stago
Asnières sur Seine, Ile-de-France, France

Co-Author(s)

Bd

Bas de Laat

General Director
Synapse Research Institute
Maastricht, Limburg, Netherlands
Joke Konings, PhD

Senior Scientist
Synapse Research Institute
Maastricht, Limburg, Netherlands
Aurélien Lebreton, MD,PhD

MD
Service d’hématologie, CHU Clermont-Ferrand, Hôpital Estaing, France
Clermont Ferrand, Auvergne, France
VL

Véronique Le Cam

Professeur des Universités - Praticien Hospitalier
CHU de Rouen, Service d’Hématologie Biologique, Unité d’hémostase
Rouen, Basse-Normandie, France
PS

Philippe Savard

Praticien hospitalier
CHU Dijon, Laboratoire d'Hématologie - filière Hémostase
Dijon, Bourgogne, France
ED

Emmanuel De Maistre

Praticien Hospitalier
CHU Dijon, Laboratoire d'Hématologie - filière Hémostase
Dijon, Bourgogne, France

Background: Heparin is still widely used for the prevention and treatment of thromboembolic diseases. Monitoring of heparin therapy is required for all patients receiving unfractionated heparin (UFH), due to its non-linear pharmacokinetic and pharmacodynamic profile, whereas it is only recommended for specific populations of patients receiving low molecular weight heparin (LMWH). sthemO Anti-Xa M is a reagent that allows quantitative determination of the potentiating effect of UFH and LMWH on antithrombin by measuring anti-Xa activity in a competitive assay using a synthetic chromogenic substrate performed on sthemO analyzers.

Aims: The objective of this study was to validate the performances of sthemO Anti-Xa M reagent on sthemO 301 by demonstrating its substantial equivalence to STA® - Liquid Anti-Xa on STA-R Max®.

Methods: This study was performed in three different centers. Normal and pathologic Quality Controls (QCs) were tested at the beginning and at the end of each run during sample testing to validate the runs on both instruments. The method comparison was performed in accordance with the CLSI guideline EP09c. The study population is described in table 1.

Results: All QCs were within the expected ranges, with a standard deviation (SD) between 0.02 IU/mL and 0.03 IU/mL for sthemO UFH QCs and between 0.03 IU/mL and 0.04 IU/mL for sthemO LMWH QCs. All acceptance criteria were met for the method comparison and results are presented in table 2. The normal values were also verified to be < 0.10 IU/mL on 20 samples.

Conclusion(s): SthemO Anti-Xa M on sthemO 301 is equivalent to STA® - Liquid Anti-Xa on STA-R Max® over the measurement range [0.10 – 2.00] IU/mL and is then validated for its intended purpose.