A Hybrid Ensemble System for Time-Series Anomaly Detection in Automated Quality Control of Medical Equipment

Background/Objectives: The accuracy and reliability of automated clinical analyzers are fundamental to patient safety and effective medical decision-making. Traditional quality control (QC) methods, which rely on periodic manual calibration and reactive maintenance, are inherently limited by high latency and labor costs; furthermore, they fail to provide continuous, real-time monitoring. This paper introduces a novel hybrid ensemble learning framework for the automated quality inspection of medical devices through the analysis of time-series reaction curves. Methods: Our system integrates three heterogeneous anomaly detection paradigms: an Enhanced Dynamic Time Warping (DTW) detector for robust non-linear pattern matching, a Shape Template Matching (STM) detector that mimics expert clinical logic by analyzing morphological features in a normalized shape space, and a specialized Time-series Variational Autoencoder (TimeVAE) for deep representation learning. The outputs of these detectors are fused using a weighted ensemble strategy, which is specifically designed to prioritize the minimization of false negatives-a critical requirement in medical diagnostics. Results: We evaluate our framework on a comprehensive, multi-center real-world dataset comprising seven distinct biochemical assays. Experimental results demonstrate that our proposed method achieves superior performance, attaining a 0% false negative rate on CRE and DBIL assays and outperforming all baseline methods on the other five datasets. An ablation study confirms the model's robustness even with limited training data, and a comparative analysis against eight state-of-the-art baseline methods further validates the effectiveness of our domain-optimized ensemble approach. Conclusions: The system provides a robust, interpretable, and highly automated solution for transitioning from reactive maintenance to proactive, real-time quality assurance in clinical laboratories.