Evaluation of the performance of systems for whole blood C-reactive protein detection: a multi-center study
Cheng Juan, Li Huaiyuan, Liu Haipeng, Wang Yuxin, Xu Jin, She Shangyang, Qu Wei, Wu Yidong, Li Guixia, Yang Junmei, Mo Liya, Xiang Yun, Ke Jiangwei, Kui Liyue, Zheng Lei, Chen Hongbing, Yang Zhili, Lyu Xin, Zhang Hong, Tang Zhenhua, Ma Lijuan, Luo Hongquan, Li Xiangyang, Zhang Wenli, Jia Hui, Ye Huiming, Tian Lijun, Pan Qiuhui
Abstract
ObjectiveTo explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.
MethodsA total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.
ResultsWithin the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab)2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients (r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L.
ConclusionThe performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.
Key words:
C-reactive protein; Detection system; Evaluation of performance; Multi-center study
Contributor Information
Cheng Juan
Department of Clinical Laboratory, Shanghai Children′s Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai 200127, China
Li Huaiyuan
Department of Clinical Laboratory, Shanghai Children′s Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai 200127, China
Liu Haipeng
Department of Clinical Laboratory, Anhui Provincial Children′s Hospital, Hefei 230051, China
Wang Yuxin
Department of Clinical Laboratory, Dalian Municipal Women and Childen′s Medical Center(Group), Dalian 116033, China
Xu Jin
Department of Clinical Medical Laboratory, Children′s Hospital of Fudan University, Shanghai 201102, China
She Shangyang
Laboratory Department, Children′s Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning 530002, China
Qu Wei
Department of Clinical Laboratory, Guiyang Maternal and Child Health Hospital/Guiyang Children′s Hospital, Guiyang 550003, China
Wu Yidong
Clinical Laboratory, Hangzhou Children′s Hospital, Hangzhou 310014, China
Li Guixia
Department of Laboratory Medicine, Children′s Hospital of Hebei Province, Shijiazhuang 050031, China
Yang Junmei
Department of Laboratory, Henan Children′s Hospital Zhengzhou Children′s Hospital, Zhengzhou 450018, China
Mo Liya
Department of Clinical Laboratory Center, Hunan Children′s Hospital, Changsha 410007, China
Xiang Yun
Department of Clinical Laboratory, Tongji Medical College, Huazhong University of Science &
Technology, Wuhan 430016, China
Ke Jiangwei
Department of Clinical Laboratory, Jiangxi Provincial Children′S Hospital, Nanchang 330006, China
Kui Liyue
Department of Clinical Laboratory, Kunming Children′s Hospital, Kunming 650000, China
Zheng Lei
Department of Laboratory Medicine, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
Chen Hongbing
Department of Clinical Laboratory, Children′s Hospital of Nanjing Medical University, Nanjing 210008, China
Yang Zhili
Department of Clinical Laboratory, Inner Mongolia Maternity and Child Health Care Hospital, Huhehaote 010010, China
Lyu Xin
Clinical Laboratory, Qilu Children′s Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250022, China
Zhang Hong
Department of Clinical Laboratory, Shanghai Children Hospital, Shanghai 200063, China
Tang Zhenhua
Department of Laboratory Medicine, the International Peace Maternity and Child Health Hospital, Shanghai 200030, China
Ma Lijuan
Department of Clinical Laboratory, Children′s Hospital Affiliated to Capital Institute of Pediatrics, Beijing 100020, China
Luo Hongquan
Department of Clinical Laboratory, Sichuan Provincial Hospital for Women and Children, Chengdu 610031, China
Li Xiangyang
Department of Clinical Laboratory,the 2nd Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China
Zhang Wenli
Department of Medical Laboratory, Urumqi Children′s Hospital, Urumqi 830002, China
Jia Hui
Clinical Laboratory, Northwest Women &
Children Hospital, Xi′an 710061, China
Ye Huiming
Clinical Laboratory, Women and Children′s Hospital, School of Medicine, Xiamen University, Xiamen 361004, China
Tian Lijun
Department of Clinical Laboratory, Xuzhou Children′s Hospital, Xuzhou 221006, China
Pan Qiuhui
Department of Clinical Laboratory, Shanghai Children′s Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai 200127, China
