PB1413 - Evaluation of the qLabs FIB system, a novel rapid and easy-to-use point-of-care system to quantify functional fibrinogen level using a single drop of citrated whole blood sample.

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Co-Author(s)

SS

Sandra SANFILIPPO

Research scientist Point-of-care Department
Diagnostica Stago R&D, Gennevilliers, France.
GENNEVILLIERS, Ile-de-France, France
LB

Leslie BUISSON

R&D Engineer Point-of-care Department
Diagnostica Stago R&D, Gennevilliers, France.
Gennevilliers, Ile-de-France, France
HR

Hafsa ROUABEHI

R&D Technician Point-of-care Department
Diagnostica Stago R&D, Gennevilliers, France.
Gennevilliers, Ile-de-France, France
FD

François Depasse, PharmD, PhD

Clinical Development Director
Diagnostica Stago
Asnières Sur Seine, Ile-de-France, France
EP

Edith PEYNAUD -DEBAYLE

Head of hospital laboratory
Department of Biological Hematology and Transfusion, Louis-Mourier Hospital, Colombes, France.
Colombes, Ile-de-France, France
BD

Bénédicte DUMONT

Hospital practitioner
Department of Biological Hematology and Transfusion, Louis-Mourier Hospital, Colombes, France.
Colombes, Ile-de-France, France

Presenting Author(s)

TD

Thibault DONNET

R&D Manager Point-of-care Department
Diagnostica Stago R&D, Gennevilliers, France.
Gennevilliers, Ile-de-France, France

Background: Fibrinogen is an early predictor of obstetric postpartum hemorrhage (PPH) severity, and current guidelines recommend maintaining the plasma fibrinogen level above 2.0 g/L (Kozek-Langenecker et al., 2016 and Shaylor et al., 2017). However, laboratory assessment of fibrinogen concentration from plasma, involves time-consuming preanalytical steps that could impact the time to diagnosis and management of massive bleeding.
The electrometer and the test strip are components of the qLabs FIB system (Micropoint Bioscience) (Figure). After 15 µL citrated blood drop deposition on the strip, the electrometer measures blood flow rate along microfluidic thrombin-coated channels and displays fibrinogen plasma concentration taking into account the sample hematocrit measured simultaneously. This point-of-care device allows a functional fibrinogen measurement from 1.0 to 4.0 g/L of plasma in less than 10 minutes and is insensitive to platelet count (until 800 000/µL) as well as heparin therapy (until 2 UI/mL).

Aims: Evaluate analytical performances of the qLabs FIB system.

Methods: The qLabs FIB was evaluated through a comparative study with the STA®- Liquid Fib assay on STAR Max (Stago). A three-laboratory comparison study was conducted to assess reproducibility and repeatability of the qLabs FIB using whole blood samples and plasma Quality Controls.

Results: Comparison analysis showed a robust correlation (Passing Bablok regression, R²>0,92) between the qLabs FIB and the reference method. The mean bias was ± 0.4 g/L for a fibrinogen level below 1.5 g/L, and inferior to 15% (95%, CI) (± 0.2 g/L) for a fibrinogen level within the [1,5-4.0 g/L] range.
Between-run/between-site and within-run reproducibility were satisfactory with CVs ≤10% and ≤8% respectively.

Conclusion(s): The qLabs FIB system enables a rapid and reliable measurement of fibrinogen levels from citrated whole blood. Further studies should investigate the performance of qLabs FIB device in critical care settings and confirm its ability to guide management of critical bleeding, especially for PPH.