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Updated: Jun 9, 2026

An Application for Pairing with Wearable Devices to Monitor Personal Health Status
Published on: February 3, 2022
Application and developing various evaluation indicators for validating the effectiveness of the harmonisation
Xue Yuan1, Wei Zhang2, Xiaoling Wang3
1The Second Hospital of Tianjin Medical University, Tianjin, China.
Objectives:
An international harmonisation protocol has been proposed to establish metrological traceability in ISO 21151:2020. This study aimed to discuss evaluation indicators mentioned in ISO 21151:2020 as well as more evaluation indicators introduced in this study for multiple scenarios, then to perform a clinical validation.
Methods:
Algorithm of Interpolation Calibration Based on Bias Correction of Current Results (ICBCCR) was applied to achieve harmonisation of 15 measurands on different in vitro diagnostic measurement devices (IVD MDs). Various evaluation indicators were applied to evaluate the harmonisation effectiveness for single measurand of single IVD MD, single measurand across multiple IVD MDs and multiple measurands from single IVD MD, respectively. A clinical validation for harmonisation effectiveness was further performed with a multi-center real-world cohort and Bhattacharyya distance (DB) served as a robust metric to compare the similarity of two probability distributions of the harmonised results from the 2 IVD MDs.
Results:
Among 15 measurands selected in this study, when Mean bias combined with S/I mentioned in ISO 21151:2020 were used as evaluation indicators, the acceptance rate of harmonisation results was 85.29 % (58/68). When Mean bias , S/I together with MAX |95%LoAs|, Mean |RD|, Bias% mdml and ρ PB were overall considered, the acceptance rate was 70.59 % (48/68). In real-world validation, DB of harmonised results for FT3 and FT4 with acceptable harmonisation performance were 0.0086 and 0.0175, significantly lower than 0.0438 and 0.0429 for CA19-9 and NT-proBNP with unacceptable harmonisation performance.
Conclusions:
Harmonisation effectiveness is able to be validated with various evaluation indicators according to different scenarios.
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