Abstract:

Objective　To verify the performance of Getein1600 dry immunofluorescence quantitative analyzer in the determination of procalcitonin (PCT), to ensure the accuracy and reliability of the PCT assay results, and to provide quality assurance for clinical practice. Methods The precision, accuracy, and linear range of PCT assay via Getein1600 dry immunofluorescence quantitative analyzer were verified based on the requirements of the relevant Chinese industry guidelines (WS/T 420-2013) by collecting specimens from Clinical Laboratory, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine in August 2019 and designing the test. Results　The reproducibility standard deviations (S_r) were 0.01 and 0.59; the intermediate precisions (S_l) were 0.01 and 0.57; the relative bias (¯b_rel) between the investigated method and the reference method was 19.01; the linearity was established within the range of 0.10-36.81 μg/L, with a R² of 0.997 9. All the verification results were within the range in the Instructions for Use. Conclusion　Getein1600 dry immunofluorescence quantitative analyzer shows a good performance in PCT assay, and is suitable for the measurement of clinical samples.

Key words: Procalcitonin, Performance verification, Dry immunofluorescence

摘要： 目的　对基蛋Getein 1600干式免疫荧光法检测降钙素原（PCT）进行性能验证，以确保检测结果的准确性和可靠性，为临床提供质量保证。方法　参考国家相关卫生行业标准（WS/T 420-2013），通过收集2019年8月广州中医药大学第二附属医院检验科34例无脂血、无黄疸、无溶血的肝素锂抗凝标本并设计试验，采用基蛋Getein 1600干式免疫荧光法检测PCT的精密度、正确度、线性范围，并进行性能验证。结果　重复标准差S_r为0.01、0.59，期间标准差S_l为0.01、0.57；与比较方法相对偏移¯b_rel为19.01；在0.10～36.81 μg/L内，R²=0.997 9。均在说明书范围内。结论　基蛋Getein 1600干式免疫荧光法检测PCT的主要分析性能良好，可用于临床标本的检测。

关键词: 降钙素原, 性能验证, 干式免疫荧光法