Performance evaluation of whole blood C-reactive protein detection system of BC-7500CS automated hematology analyzer
10.19745/j.1003-8868.2024236
- VernacularTitle:BC-7500CS全自动血细胞分析仪全血C反应蛋白检测系统性能验证
- Author:
Chun-zheng LIN
1
;
Zhi-zhong GAN
1
;
Sheng-qiang LIANG
1
Author Information
1. 第九○九医院(厦门大学附属东南医院)检验科,福建漳州 363000
- Publication Type:Journal Article
- Keywords:
BC-7500CS automated hematology analyzer;
whole blood C-reactive protein detection system;
C-reactive protein;
blood test;
performance validation
- From:
Chinese Medical Equipment Journal
2024;45(12):55-60
- CountryChina
- Language:Chinese
-
Abstract:
Objective T o validate the performance of the whole blood C-reactive protein(CRP)detection system of BC-7500CS automated hematology analyzer.Methods The whole blood CRP detection system of BC-7500CS automated hematology ana-lyzer was verified based on relevant industrial standards in terms of blank determination,carry-over contamination rate,precision,linear range,comparability of different detection systems,correctness,interference test(triglyceride,bilirubin),auto-correction formula of hematocrit and biological reference interval.Results The whole blood CRP detection system had the blank determination results less than 0.2 mg/L and the carry-over contamination rate being 0.01％.The within-run standard deviations(SDs)of the system for the samples with normal and pathological concentrations were 0.05 and 0.78 mg/L respecti-vely,and the between-run SDs were 0.38 and 1.99 mg/L respectively;the within-run coefficients of variation of the system for the samples with normal and pathological concentrations were 1.05％and 1.61％respectively,and the between-run SDs were 6.83％and 3.95％respectively.The linear range of the system for CRP detection was restricted within 0 and 274.03 mg/L.The system correlated well with BNII speical protein analyzer for CRP detection with r≥0.975.The biases of the system for detecting the reference material were all within±10％.Interference tests showed that the relative deviations of CRP were all within±10％between the samples with or without triglyceride(concentration ≤427.2 mmol/L)and between the samples with or without bilirubin(concentration ≤433 pmol/L).The auto-correction formula of hematocrit proved the system behaved well in linearity.The results of the biological reference interval validation indicated that the CRP values of the samples were well within the existing biological reference intervals and met the requirements.Conclusion The whole blood CRP detection system of BC-7500CS automated hematology analyzer has its performance indexes meet the requirements of the manufacturer and relevant standards,and can be applied clinically.[Chinese Medical Equipment Journal,2024,45(12):55-60]
