Evidence map›Paper›PMID 41403909›Full record

ArticleTH open : companion journal to thrombosis and haemostasis2025

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

Yanhong Liu, Bo Guo, Guanghui Chen, Caixia Chen, Zhen Meng, Yan Xie, Yanru Fan, Rufei Ma, Lan Gao

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in TH open : companion journal to thrombosis and haemostasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yanhong LiuDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Bo GuoDepartment 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 ChenDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Caixia ChenDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Zhen MengDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Yan XieDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Yanru FanDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Rufei MaDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.
Lan GaoDepartment of Laboratory Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University, Zhengzhou, Henan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

a2-plasmininhibitor–plasmin complexperformance verificationthrombin–antithrombin complexthrombomodulinthrombosis and hemostasis

Identifiers

PMID41403909
PMCPMC12704508

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.