An integrated framework for universal coagulation test reference intervals: Cross-platform validation of eleven indirect algorithms and age-specific hierarchical optimization.
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| Title: | An integrated framework for universal coagulation test reference intervals: Cross-platform validation of eleven indirect algorithms and age-specific hierarchical optimization. |
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| Authors: | Wu Y; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Huang T; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Huang H; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Yu F; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Liu J; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Tang X; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Chen L; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China., Zhou Y; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China. Electronic address: yiwenzhou21@aliyun.com., He H; Center of Clinical Laboratory, Shenzhen Hospital, Southern Medical University, Shenzhen, Guangdong, China. Electronic address: herotod83@smu.edu.cn. |
| Source: | Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2025 Aug 15; Vol. 576, pp. 120422. Date of Electronic Publication: 2025 Jun 09. |
| Publication Type: | Journal Article; Validation Study |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 1302422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3492 (Electronic) Linking ISSN: 00098981 NLM ISO Abbreviation: Clin Chim Acta Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Amsterdam, Elsevier. |
| MeSH Terms: | Algorithms*, Blood Coagulation Tests/standards ; Humans ; Female ; Male ; Middle Aged ; Adult ; Reference Values ; Aged ; Retrospective Studies ; Young Adult ; Adolescent ; Age Factors ; Aged, 80 and over ; Child ; Child, Preschool ; Infant |
| Abstract: | Background: The conventional direct method for establishing coagulation reference intervals (RIs) faces challenges, including difficulties in recruiting healthy populations, non-Gaussian distributions, and complex age-related effects. Indirect methods utilizing real-world data (RWD) are limited by a lack of consensus on algorithm selection and insufficient cross-platform validation. Objective: To develop a multi-algorithm collaborative framework for systematically evaluating the performance of 11 outlier detection algorithms, thereby optimizing coagulation RIs for the Chinese population and validating their cross-platform applicability. Methods: We retrospectively analysed 630,946 coagulation test records from Shenzhen Hospital of Southern Medical University. Outlier removal was performed using eleven algorithms. Algorithm stability and sex/age effects were quantified via reference change value (RCV) and variance component models. Validation was conducted across Mindray CX-9000 and Stago STA R Max platforms. Results: Among the 11 algorithms, Z-Score and Tukey demonstrated optimal performance for 8 coagulation parameters, yielding RIs with minimal deviation from manufacturer standards. Sex-based analysis revealed minimal differences (Standard deviation ratio (SDR) < 0.40, Standardized effect size (Cohen's d) <0.50), eliminating the need for sex stratification. Age stratification was required for D-Dimer (≥60 years subgroup: SDR = 0.62, Cohen's d = 0.54). Cross-platform consistency confirmed algorithm generalizability. Conclusions: This RCV-driven multi-algorithm framework establishes the Z-Score and Tukey methods as optimal for coagulation RIs derivation, advocates age-specific D-Dimer RIs, and deems sex stratification unnecessary. This scalable approach enhances standardization in coagulation testing. (Copyright © 2025 Elsevier B.V. All rights reserved.) |
| Contributed Indexing: | Keywords: Coagulation; Indirect method; Real-world data (RWD); Reference change value (RCV); Reference intervals (RIs) |
| Entry Date(s): | Date Created: 20250611 Date Completed: 20250624 Latest Revision: 20250624 |
| Update Code: | 20260130 |
| DOI: | 10.1016/j.cca.2025.120422 |
| PMID: | 40499770 |
| Database: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Background: The conventional direct method for establishing coagulation reference intervals (RIs) faces challenges, including difficulties in recruiting healthy populations, non-Gaussian distributions, and complex age-related effects. Indirect methods utilizing real-world data (RWD) are limited by a lack of consensus on algorithm selection and insufficient cross-platform validation.<br />Objective: To develop a multi-algorithm collaborative framework for systematically evaluating the performance of 11 outlier detection algorithms, thereby optimizing coagulation RIs for the Chinese population and validating their cross-platform applicability.<br />Methods: We retrospectively analysed 630,946 coagulation test records from Shenzhen Hospital of Southern Medical University. Outlier removal was performed using eleven algorithms. Algorithm stability and sex/age effects were quantified via reference change value (RCV) and variance component models. Validation was conducted across Mindray CX-9000 and Stago STA R Max platforms.<br />Results: Among the 11 algorithms, Z-Score and Tukey demonstrated optimal performance for 8 coagulation parameters, yielding RIs with minimal deviation from manufacturer standards. Sex-based analysis revealed minimal differences (Standard deviation ratio (SDR) < 0.40, Standardized effect size (Cohen's d) <0.50), eliminating the need for sex stratification. Age stratification was required for D-Dimer (≥60 years subgroup: SDR = 0.62, Cohen's d = 0.54). Cross-platform consistency confirmed algorithm generalizability.<br />Conclusions: This RCV-driven multi-algorithm framework establishes the Z-Score and Tukey methods as optimal for coagulation RIs derivation, advocates age-specific D-Dimer RIs, and deems sex stratification unnecessary. This scalable approach enhances standardization in coagulation testing.<br /> (Copyright © 2025 Elsevier B.V. All rights reserved.) |
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| ISSN: | 1873-3492 |
| DOI: | 10.1016/j.cca.2025.120422 |