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CC BY 4.0 · TH Open 2025; 09: a27518459
DOI: 10.1055/a-2751-8459
Original Article

Performance Verification of High Sensitivity Analyzer for TAT, PIC, TM, and t-PAIC

Authors

  • Yanhong Liu

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Bo Guo

    2   Department of Critical Care Medicine, Henan Key Laboratory for Critical Care Medicine, Zhengzhou Key Laboratory for Critical Care Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Guanghui Chen

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Caixia Chen

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Zhen Meng

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Yan Xie

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Yanru Fan

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Rufei Ma

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

  • Lan Gao

    1   Department of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China

Funding This study was supported by Science and Technology Research Project of Henan Provincial Department of Science and Technology (242102311114) and the Projects Approved for New Business and Technology Access Audits of Henan Provincial People's Hospital in 2022 (2231272006).
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Abstract

Background

Thrombin–antithrombin complex (TAT), a2-plasmininhibitor–plasmin complex (PIC), thrombomodulin (TM), tissue plasminogen activator–plasminogen activator inhibitor complex (t-PAIC) has been increasingly applied in clinical practice in recent years, especially in the diagnosis and treatment of diseases associated with thrombosis and hemorrhage. However, there is no universally accepted evaluation standard for the performance verification of these four indicators currently. Therefore, we designed experiments to verify the precision, trueness, carryover, linearity, and reference intervals of these four indicators. This study is expected to provide references for subsequent research in terms of data and experimental methods.

Methods

According to the Clinical and Laboratory Standards Institute (CLSI) guidelines EP15-A2, EP06-A, and C28-A, the precision, trueness, carryover, linearity, and reference intervals were evaluated.

Results

The within-laboratory CVs of TAT, PIC, TM, and t-PAIC were 3.67, 6.51, 3.64, and 2.46% on Control L and 4.68, 4.67, 5.08, and 3.87% on Control H. The assigned value of calibrations of TAT, PIC, TM, and t-PAIC were all included in the verification intervals. The biases of the four items of Calibration 1 were −6.67, −0.90, −3.58, and −6.78% and biases on Calibration 2 were −2.70, 1.63, 2.66, and −1.16%, respectively, compared with the assigned value provided by the manufacturer. The carryover rate of each indicator was less than 1%. Within the range that meets clinical use, the best fit curves of the four indicators were linear, and the correlation coefficients of all indicators were greater than 0.99. The reference intervals provided by the manufacturer were appropriate in our laboratory.

Conclusion

The performance of HISCL-5000 analyzer for TAT, PIC, TM, and t-PAIC analysis were acceptable and the systems were suitable for clinical analysis.

Keywords

performance verification - thrombosis and hemostasis - thrombin–antithrombin complex - a2-plasmininhibitor–plasmin complex - thrombomodulin


Publication History

Received: 15 July 2025

Accepted: 07 November 2025

Article published online:
13 December 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Bibliographical Record
Yanhong Liu, Bo Guo, Guanghui Chen, Caixia Chen, Zhen Meng, Yan Xie, Yanru Fan, Rufei Ma, Lan Gao. Performance Verification of High Sensitivity Analyzer for TAT, PIC, TM, and t-PAIC. TH Open 2025; 09: a27518459.
DOI: 10.1055/a-2751-8459
 

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