Abstract Number: PB0385
Meeting: ISTH 2021 Congress
Background: The novel Haema T4 Thromboelastograph (MedCaptain Medical Technology Co., Shenzhen, Guangdong, China) is an analyzer for monitoring, measuring, and analyzing the coagulation process of a blood sample. With the qualitative and semi-quantitative test results an automatically generated prediction of the patient’s blood coagulation condition is made.
Aims: In this study, the intra-assay, inter-assay, day-to-day precision, sample- and reagent stability, inter-lotnumber variation and reference values were established for the Kaolin Activation Test (Kaolin), Rapid Kaolin Test (R-Kaolin), Heparin assay (HEP), functional Fibrinogen assay (FIB) and platelet aggregation assay (AA+ADP) (MedCaptain).
Methods:
Results: The biochemical reactions of the coagulation cascade and clot formation process are characterized by measurement of the first blood clot reaction time (R), clot formation rate (K and angle), maximum clot strength (maximum amplitude, MA) and heparin monitoring index (ACT) (Figure I).
The biochemical reactions of the coagulation cascade and clot formation process are characterized by measurement of the first blood clot reaction time (R), clot formation rate (K and angle), maximum clot strength (maximum amplitude, MA) and heparin monitoring index (ACT). In addition to the five main parameters the coagulation index (CI) may also contribute to the determination of the kinetics, hardness and stability of the blood clot. Using the fibrinogen assay, the Flev value represents the content of the functional fibrinogen which can be cross-linked into fibrin.Figure I
Intra-assay (n=8), inter-assay (n=8) and day-to-day precision (n=20) of all five tests and parameters yielded appropriate results for K (CV<15%), R, angle, MA and ACT (CV<10%). Blood samples were stable for maximum 2 hours after collection at 20-25°C. Reference ranges are demonstrated in Table 1.
Table 1
| ACT (sec) | R (min) | K (min) | Angle (deg) | MA (mm) | CI | Flev (mg/dL) | |
| Kaolin | 3.3 – 6.0 | 0.8 – 2.0 | 65 – 78 | 55 – 72 | -0.1 – 3.8 | ||
| R-Kaolin | 69 – 103 | 0 – 0.9 | 0.5 – 1.5 | 74 – 85 | 44 – 82 | 3.6 – 7.4 | |
| Fibrinogen | 1.6 – 2.6 | -0.9 – 16.5 | 56 – 77 | 17 – 32 | -8.0 – 0.5 | 226 – 650 | |
| AA&ADP – F – F+AA – F+ADP – kaolin |
0.3 – 2.0 0.7 – 1.8 0.9 – 1.4 5.8 – 9.0 |
1.1 – 2.2 |
19 – 75 66 – 79 57 – 79 64 – 73 |
5 – 15 55 – 69 51 – 68 60 – 68 |
622 – 628 1.9 – 5.8 1.5 – 4.6 -1.9 – 1.5 |
Reference ranges for the kaolin, R-kaolin, Fibrinogen and AA&ADP tests, established with a reference group of 25 blood donors (Sanquin, The Netherlands)
Test results did not change during the shelf life of the reagents (9 months).
When using three different reagent batch numbers, the mutual difference for all tests ranged for K 10-15%, R 9-15%, angle 2-5%, MA 3-5% and ACT 5-7%.
Conclusions: In a laboratory setting, the novel Haema T4 Thromboelastograph yield good analytical performance for the Kaolin, R-Kaolin, HEP, FIB and AA&ADP tests.
To cite this abstract in AMA style:
Schoorl M, Jansen T, van Pelt J. Analytical Performance of the Novel Haema T4 Thromboelastograph [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/analytical-performance-of-the-novel-haema-t4-thromboelastograph/. Accessed September 22, 2023.« Back to ISTH 2021 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/analytical-performance-of-the-novel-haema-t4-thromboelastograph/