PB0087 - Evaluation of the new Stago system, sthemO II, sthemO V and sthemO X on sthemO 301 analyzer for factors II, V and X deficiencies determination

Sunday, June 23, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Co-Author(s)

SL

Sylvain Lamoine

Research ingineer
CHU Clermont-Ferrand, Service d'hématologie biologique
Clermont-Ferrand, Auvergne, France
SG

Stéphanie Guerin

Technician
CHU Clermont Ferrand, Service d’Hématologie Biologique
Clermont-Ferrand, Auvergne, France
MT

Maxence Tillier

Technician
CHU Clermont Ferrand, Service d’Hématologie Biologique
Clermont-Ferrand, Auvergne, France
AT

Alexandre Trapani

Technician
CHU Clermont-Ferrand, Service d’Hématologie Biologique
Clermont-Ferrand, Auvergne, France
AT

Adeline Trayaud

Technician
CHU Clermont-Ferrand, Service d’Hématologie Biologique
Clermont-Ferrand, Auvergne, France
Joffrey Feriel, PharmD

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

Presenting Author(s)

Aurélien Lebreton, MD,PhD

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

Background: sthemO II, sthemO V, sthemO X are tests that assess the common coagulation pathway. Inherited
factor II, V and X deficiencies are rare coagulation disorders, whereas acquired deficiencies are common laboratory findings. They can be caused by hepatic disorders, Disseminated Intravascular Coagulation (DIC), Vitamin K antagonists (VKA) therapy or hypovitaminosis K (for factors II and X).

Aims: The objective of this study was to validate the performance of sthemO II, sthemO V, sthemO X on sthemO 301, for their intended purpose by performing a comparison with STA® – Deficient II, V and X on STA R Max®.

Methods: Quality controls were measured before and after each sample run to validate the runs on both instruments. All samples were handled in accordance with the Good Study Practices (ISO 20916 Standard) and the method comparison was performed in accordance with the CLSI guideline EP09c. The population for method comparison studies consisted in normal patients, congenital and acquired deficiencies, VKA treatment, hypovitaminosis K, DIC and liver failure.

Results: All QC’s were within their expected ranges. All acceptance criteria were met for the method comparison and results are presented in table 1 and figure 1.

Conclusion(s): The sthemO II, sthemO V and sthemO X on sthemO 301 are equivalent to their predicates STA deficient II, STA deficient V and STA deficient X on STA R max® and validated for their intended purpose.