PB1129 - Analytical Performances Evaluation of the Thrombophilia Hemostasis Test Panel on sthemO 301 Analyzer

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Emilie Frisan, PhD

Project Leader
Stago R&D
Gennevilliers, Ile-de-France, France

Co-Author(s)

VG

Vincent Genty

CEO
Amarok Biotechnologies
Saint Malo, Bretagne, France
LC

Ludovic Chaillet

Lab technician
Amarok Biotechnologies
Saint Malo, Bretagne, France
CR

Clémence Rabin

Project Leader
Stago R&D
Gennevilliers, Ile-de-France, France
MH

Mélanie Hébert

Project Leader
Stago R&D
Gennevilliers, Ile-de-France, France
NT

Nina Tison

R&D scientist
Stago R&D
Gennevilliers, Ile-de-France, France
FG

Flavien Grégoire

External collaborations leader
Stago Data generation laboratory
Gennevilliers, Ile-de-France, France
SL

Sylvie Langlet

Manager
Stago Data generation laboratory
Gennevilliers, Ile-de-France, France
RD

Romain DURIEZ

Project Leader
Cerba Xpert
LILLE, Nord-Pas-de-Calais, France
FL

Françoise Le Boulaire

Project Manager
Cerba Xpert
SAINT OUEN L'AUMONE, Ile-de-France, France
Audrey Carlo, MSc

Scientific Marketing Manager
Stago
Asnières-sur-seine,, Ile-de-France, France
NB

Nathalie Barat

Project Leader
Stago R&D
Gennevilliers, Ile-de-France, France
CL

Claire Legros

Manager
Stago R&D
Gennevilliers, Ile-de-France, France

Background: The strategy for exploring possible cause of a venous thromboembolic event (VTE) combines a clinical investigation with a hemostasis assessment in search of inherited or acquired risk factors among which the thrombophilia test panel of the coagulation bench.
The sthemO AT (amidolytic activity), sthemO PC Clot (chronometric activity), sthemO PC chrom (amidolytic activity), sthemO PS Free (immunoturbidimetry) and sthemO PS clot (chronometric activity) dedicated reagents associated with the new analyzer sthemO 301 are intended to be used in this purpose.

Aims: To accompany the new sthemO 301 analyzer, some applications with dedicated reagents able to quantify the AT, the protein C and protein S levels were developed.
The objectives of the studies are to evaluated the main performances of these reagents on sthemO 301 analyzer, according to the most recent versions of CLSI guidelines.

Methods: The following studies were conducted using the sthemO 301 according to CLSI guidelines:
limit of detection (LoD): EP 17-A2
limit of quantitation (LoQ): EP17 A2 (Total error approach)
linearity: EP06
precision: EP05 A3
All tests are calibrated except sthemO PS Free (precalibrated).
The levels of calibrators are assigned against their respective International Standards (directly or through a secondary standard depending on the parameter).
All reagents and analyzers were from Stago, France

Results: The results from the LoD, LoQ, linearity, and precision studies are presented in table 1:

Conclusion(s): The sthemO AT , sthemO clot PS, sthemO PS Free, sthemO PC chrom and sthemO PC clot assays demonstrate good performance on the sthemO 301 System and can be used for the quantitative determination of plasmas inhibitors in human citrated plasma.
The thrombophilia test panel will be complete when the assays to screen and confirm the presence of LA/APA will be available.