PB1155 - Analytical Performances Evaluation of the sthemO DDi Assay on the sthemO 301 Analyzer

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Co-Author(s)

ER

Emilie Ribeill

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

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
JY

Jia-Yin Yang

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

Audrey Molet

R&D technician
Stago R&D
Gennevilliers, Ile-de-France, France
SL

Sylvie Langlet

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

Flavien Grégoire

External collaborations leader
Stago Data generation laboratory
Gennevilliers, 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: D-dimers (DDi) are the terminal products of fibrin degradation by plasmin. DDi level determination is used, in conjunction with a clinical pretest probability (PTP) assessment model, to exclude venous thromboembolism in outpatients or as an aid to diagnose and monitor disseminated intravascular coagulation. High D-dimer levels can also be observed in several medical and clinical situations, among which COVID-19 infection.
Many DDi levels measurement methods and assays are available for clinical laboratories. A new assay using monoclonal antibodies adsorbed on latex particles, sthemO DDi, has been designed for quantitative DDi levels measurement on sthemO 301 analyzer.

Aims: The objective of the studies is to evaluate the main performances of the sthemO DDi reagent, ready to use (no stabilization time needed), on sthemO 301 analyzer, according to CLSI guidelines.

Methods: The following studies were conducted using the sthemO 301 according to CLSI guidelines:
limit of detection (LoD): EP17 A2
limit of quantitation (LoQ): EP17 A2 (Total error approach)
linearity: EP06-Ed2
precision: EP05 A3
stability: EP25 A
All reagents and analyzers were from Stago, France.

Results: sthemO DDi M is pre-calibrated: this pre-calibration is valid for all the kits of the same lot
Table 1 gathers the results for LoD, LoQ, linearity and stability on board sthemO 301. Table 2 consolidates the Intrasite precision study (repeatability and reproducibility) obtained with one lot of sthemO DDi reagent on 3 sthemO 301 analyzers.
Based on the results from the LoQ, linearity, and precision studies, the analytical measuring interval for the application was defined to be 0.190 µg/mL – 30,000 µg/mL (redilution included).
The hook effect, management by the instrument, has been tested up to 500.000µg/mL..

Conclusion(s): The sthemO DDi assay demonstrates very good performances on sthemO 301 analyzer, verifying it can be used for the quantitative determination of DDimer in human citrated plasma in medical explorations.