关键词: 降钙素原, 性能验证, 干式免疫荧光法

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