Evaluation of the Vision C erythrocyte sedimentation rate analyzer

Özet

Objectives: The International Council for Standardization in Haematology recommends that new methods and instru ments used in medical laboratories be thoroughly tested with an analytical performance evaluation prior to imple mentation. This study is an assessment of the analytical performance characteristics of the Vision C analyzer (Shenzhen YHLO Biotech Co., Ltd., Shenzhen, China), which uses a modified Westergren method to measure erythrocyte sedimen tation rate (ESR) and a comparison with the reference Westergren method. Methods: The analytical performance of the Vision C was evaluated according to intra-run/inter-run precision, stabil ity, and compatibility with the gold standard Westergren method. In all, 173 patient samples were studied using both methods. The Westergren method levels were used to form 3 groups: 80 mm/hour. Results: The intra-run precision ranged from 4.93% to 18.18% for 5 samples at different levels. Inter-run precision for the normal level was 7.03% and 2.94% for the pathological level. Both the room temperature and refrigerated samples were stable at 4 hours. The overall bias between the Westergren method and the Vision C analyzer was -5.23 mm/hour (confidence interval [CI]: -6.66 to -3.79), the correlation coefficient was 0.948, and the Passing-Bablok regression equa tion was y=2.073+0.805x. The bias of the Vision C for ESR values 80 mm/hour. Conclusion: The Vision C analyzer using a modified Westergren method met the precision and sample stability criteria, but the results were not fully compatible with the Westergren method at all ESR levels, and the difference was signifi cant at high ESR levels.