ABI Quantistudio Dx实时定量PCR仪HBV-DNA检测的性能验证

Performance verification of ABI Quantistudio Dx real-time fluorescent quantitative PCR HBV-DNA detection system

目的验证ABI Quantistudio Dx实时荧光定量PCR仪HBV-DNA检测系统的性能。方法参考GB/T 22576-2008和CNAS-CL36相关文件,ABI Quantistudio Dx实时荧光定量PCR仪检测患者标本、质控品及卫生部临检中心室间参考物质。从以下几个方面进行性能验证:精密度、正确度、线性范围、检出限等。结果 ABI Quantistudio Dx实时荧光定量PCR仪HBV-DNA检测系统的批内精密度(批内CV)分别为2. 09%(低浓度)、1. 3%(高浓度);批间精密度(批间CV)分别为3. 92%(低浓度)、2. 88%(高浓度);准确度评估以参加能力验证/室间质评的项目来判断,项目PT成绩为100%,通过;系统最低检出限为50 U/ml;线性范围验证结果显示,线性回归方程为Y=1. 0001X,R2=0. 9976。线性范围为1. 00×102～1. 00×108U/ml。结论 ABI Quantistudio Dx实时荧光定量PCR系统检测HBV-DNA性能良好,满足临床检测需要。

Objective To verify the performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system. Methods According to CNAS-CI36 and GB/T 22576-2008 , the analytical performance, such as precision, accuracy, limit of detection and linearity, was detennined 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 detectio n limit of this system was 50 IU/ml. The lin ear regress io n equation was Y = 1.0001 X,/R^2=0. 9976. The linearity ranged from 1.00 x 102 to 1.00 x 108 U/ml. Conclusions The performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system meets the needs of clinical detection.