With the continuous improvement of medical testing and instrumentation engineering technologies, the design, testing and development methods of in vitro diagnostic instruments are developing rapidly. In vitro diagnostic instruments are also gradually developing into a class of typical high-end medical equipment. The design of in vitro diagnostic instruments involves a variety of medical diagnostic methods and biochemical, physical and other related technologies, and its development process involves complex system engineering. This paper systematically organizes and summarizes the design, testing and development methods of in vitro diagnostic instruments and their development in recent years, focusing on summarizing the related technologies and core aspects of the R&D process, and analyzes the development trend of the in vitro diagnostic instrument market.

Diabetic retinopathy (DR) is the largest cause of permanent vision loss in the working-age population, making automated grading critical for timely therapeutic intervention. While recent deep learning algorithms have improved feature discrimination, modern state-of-the-art systems have two fundamental drawbacks. First, most models rely on standard Convolutional Neural Networks, which struggle to capture long-range relationships and lack semantic reasoning, resulting in visual findings that do not correlate with clinical knowledge. Second, present approaches often consider grading as a nominal classification or a pure ordinal regression task, failing to strike a compromise between high classification accuracy and severity-consistent predictions (Quadratic Weighted Kappa). To address these challenges, we propose Dual-SwinOrd, a novel framework that integrates a hierarchical Vision Transformer with a semantically guided dual-head mechanism. Specifically, we use a Swin Transformer backbone to extract hierarchical features, effectively capturing global retinal structures. To handle diverse lesion scales, we incorporate a Progressive Lesion-aware Kernel Attention (PLKA) module and a Semantic Prior Modulation (SPM) module guided by PubMedCLIP, bridging the gap between visual features and medical linguistic priors. In addition, we propose a Dual-Head learning strategy that decouples the optimization objective into two parallel streams: a Classification Head to maximize diagnostic accuracy and an Ordinal Regression Head (DPE) to enforce rank-consistency. This design effectively mitigates the trade-off between precision and ordinality. Extensive experiments on the APTOS 2019 and DDR datasets demonstrate that Dual-SwinOrd achieves state-of-the-art performance, yielding an Accuracy of 87.98% and a Quadratic Weighted Kappa (QWK) of 0.9370 on the APTOS 2019 dataset, as well as an Accuracy of 86.54% and a QWK of 0.9040 on the DDR dataset.

Gout is one of the most painful diseases in the world. Accurate classification of gout is crucial for diagnosis and treatment which can potentially save lives. However, the current methods for classifying gout periods have demonstrated poor performance and have received little attention. This is due to a significant data imbalance problem that affects the learning attention for the majority and minority classes. To overcome this problem, a resampling method called ENaNSMOTE-Tomek link is proposed. It uses extended natural neighbors to generate samples that fall within the minority class and then applies the Tomek link technique to eliminate instances that contribute to noise. The model combines the ensemble ’bagging’ technique with the proposed resampling technique to improve the quality of generated samples. The performance of individual classifiers and hybrid models on an imbalanced gout dataset taken from the electronic medical records of a hospital is evaluated. The results of the classification demonstrate that the proposed strategy is more accurate than some imbalanced gout diagnosis techniques, with an accuracy of 80.87% and an AUC of 87.10%. This indicates that the proposed algorithm can alleviate the problems caused by imbalanced gout data and help experts better diagnose their patients.