Comparison between the automated TEG®6s and viscoelastic analyzer Haema T4

Area of Science:

• Hemostasis and Thrombosis
• Medical Device Technology
• Point-of-Care Diagnostics

Background:

• Viscoelastic testing is crucial for point-of-care coagulation management.
• Novel viscoelastic analyzers are emerging, necessitating comparison with established devices.
• This study evaluates the Haema T4 (HT4) against the TEG®6s.

Purpose of the Study:

• To compare the performance of the novel Haema T4 (HT4) viscoelastic analyzer with the established TEG®6s.
• To assess the agreement and correlation of coagulation parameters between the two devices.
• To determine the interchangeability of results for clinical application.

Main Methods:

• Utilized combined extrinsic-intrinsic activation (CRT), intrinsic activation (CK/kaolin), and fibrinogen polymerization (CFF/FIB) assays on both HT4 and TEG®6s devices.
• Measured key viscoelastic parameters: activated clotting time (ACT), reaction time (r-time), kinetic time (k-time), and maximum amplitude (MA).
• Assessed parameter agreement and correlation under various experimental conditions.

Main Results:

• The TEG®6s yielded higher ACT, r-time, and k-time but lower MA values compared to the HT4.
• Weak correlation and substantial bias were observed for ACT in the CRT assay.
• Strong correlations and minimal bias were found for MA in CRT, CK/kaolin, and CFF/FIB assays.

Conclusions:

• Despite strong correlations in certain parameters like maximum amplitude, overall agreement between the HT4 and TEG®6s was limited.
• Results from the HT4 and TEG®6s are not interchangeable due to significant bias and differing parameter values.
• Device-specific reference ranges and clinical outcome studies are essential before the HT4 can be integrated into clinical practice.