Performance verification of ABI Quantistudio Dx real-time fluorescent quantitative PCR HBV-DNA detection system
LI Pengfei1, GAO Feng1, and ZHANG Yanhui2
1.Department of Clinical Laboratory, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China; 2.Department of Clinical Laboratory, Jiangsu Provincial Corps Hospital of PAP, Yangzhou 225003, China
Abstract：Objective To verify the performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system.Methods According to CNAS-CL36 and GB/T 22576-2008, the analytical performance, such as precision, accuracy, limit of detection and linearity,was determined by ABI Quantistudio Dx real-time PCR system. Patient specimens, quality products, and reference materials from the National Center for Clinical Laboratories (NCCL) were employed for performance verification.Results The coefficient of variation (CV) of intra-assay of specimens with low concentration and high concentration of ABI Quantistudio Dx real-time PCR system was 2.09% and 1.3%, respectively, while the CV of inter-assay of specimens with a low concentration and high concentration was 3.92% and 2.88%, respectively. Analysis of reference materials from NCCL showed that test results were highly accurate. The detection limit of this system was 50 IU/ml. The linear regression equation was Y=1.0001X, R2=0.9976. The linearity ranged from 1.00×102 to 1.00×108 U/ml.Conclusions The performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system meets the needs of clinical detection.
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2019, Vol. 30 
