Interference Studies of In Vitro Diagnostic
Reagents Based on WS/T 356—2024

doi:magtech.2025.08.14-00002

Abstract

Abstract:

Objective： To establish a novel visualized interference study method for in vitro diagnostic reagents based on WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials".Methods： Based on the evaluation principle outlined in WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials"， this study systematically assessed the effects of interferents（including hemoglobin， triglycerides， bilirubin， and human serum albumin）on B-type natriuretic peptide （BNP） detection reagents using Deming regression and 95% confidence interval analysis. The results were compared with those obtained using the classical approach described in WS/T 416—2013 "Guide to Interference Testing in Clinical Chemistry" to verify the reliability of the new method.Results： The novel interference study method established based on WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials" demonstrated complete consistency with the classical approach described in WS/T 416—2013 "Guide to Interference Testing in Clinical Chemistry" in terms of interference screening results. Both methods identified hemoglobin， triglycerides， bilirubin， and human serum albumin as interferents. In the dose-effect analysis， the maximum non-interfering concentrations determined by the two methods were also identical： 500 mg·dL^-1 for hemoglobin， 3000 mg·dL^-1 for triglycerides， 20 mg·dL^-1 for bilirubin， and 1500 mg·dL^-1 for human serum albumin. Furthermore， the novel method enabled visualized interpretation of results through Deming regression plots， significantly enhancing analytical efficiency and intuitiveness.Conclusion： The visualized interference study method established based on WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials" is reliable and effective， which demonstrates good consistency with the classical method， and provides a new research direction for the interference assessment of in vitro diagnostic reagents.

Key words: Commutability； , Visualization； , WS/T356—2024； , Interference screening； , Dose-effect

CLC Number:

R446

FU Yang, ZHENG Weiwei, ZHOU Fan, HUANG Li, YAN Zhifen, GENG Linlin, LIN Qifeng.

Interference Studies of In Vitro Diagnostic Reagents Based on WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials" [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2026, 28(5): 528-528-535.

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Interference Studies of In Vitro Diagnostic Reagents Based on WS/T 356—2024 "Guideline for Evaluation of Commutability of Reference Materials"

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