Multicenter clinical validation of a novel rapid single-integrated TAT immunoassay and combined thrombosis biomarker panel for venous thromboembolism risk stratification in colorectal cancer.
Meng Liu, Chaolin Guo, Hongsheng Zhou, Ziyan Xie, Yankun Yang, Kuiqi Jin, Jianqi Nie, Jinhua Xiao, Yang Sun, Zhonghu Bai
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引用次数: 0
Abstract
Objectives: This study aimed to validate the reliability of a novel point-of-care testing technology for measuring the thrombin-antithrombin III complex (TAT) and to evaluate its utility in evaluating venous thromboembolism (VTE) risk and enabling dynamic monitoring in patients with colorectal cancer (CRC).
Design and methods: The novel immunoassay for TAT measurement was assessed against a reference system. Biomarker levels-including TAT, plasmin-α2-antiplasmin complex (PIC), thrombomodulin (TM), and tissue plasminogen activator-inhibitor complex (tPAIC)-were quantified in patients with CRC and healthy controls. Statistical analyses were conducted to assess differences among various groups. Receiver operating characteristic (ROC) curve analysis was employed to evaluate the predictive performance of biomarkers for VTE risk stratification.
Results: The novel TAT assay showed excellent correlation with the reference method (r > 0.99). All biomarkers were significantly elevated in CRC patients compared to healthy controls (p < 0.001), with TAT and PIC levels increasing by 3.5-fold and 2.4-fold, respectively. Significant differences in the levels of TAT, PIC, and tPAIC were also observed between CRC patients with VTE and those without VTE (p < 0.001). Advanced-stage patients showed a median TAT concentration 1.8-fold higher than early-stage patients (p < 0.001). ROC analysis revealed strong predictive performance for TAT and the combined biomarker model, with an area under the curve (AUC) of 0.9544, sensitivity of 90.5 %, and specificity of 93.5 %.
Conclusions: The novel TAT immunoassay represents a reliable system for clinical application. Furthermore, a combined biomarker model enhances VTE risk stratification in CRC patients, providing a valuable strategy for personalized anticoagulant therapy and dynamic monitoring.
期刊介绍：
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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