Quality Control Planning of a Hepatitis B Viral Load Laboratory-Developed Assay
محل انتشار: فصلنامه آسیب شناسی ایران، دوره: 9، شماره: 1
سال انتشار: 1393
نوع سند: مقاله ژورنالی
زبان: انگلیسی
مشاهده: 698
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شناسه ملی سند علمی:
JR_IJP-9-1_003
تاریخ نمایه سازی: 5 آبان 1393
چکیده مقاله:
Background and Objectives: HBV DNA monitoring is important in management of chronic viral hepatitis B infection. HBV DNA measurements are carried out over period of months to years. So the analytical system must be stable and reproducible. The aim of this study was to determine the performance characteristics and to plan a statistical quality control system of a laboratory-developed real-time quantitative PCR assay for HBV DNA quantification.Methods: Values of systematic and random error at two clinical decision points;4.2 Log IU/mL (20000 IU/mL) and 3.2 Log IU/mL (2000 IU/mL) were determined. Candidate quality control procedures were selected and performance of the method by application of normalized operational process specification (OPSpecs) charts was determined.Results: The performance of the assay at level of 4.2 Log IU/mL and 3.2 Log IU/mL were excellent and good respectively. Moreover, a13.5S rule with two measurements offered 90% probability of error detection at level of 4.2 Log IU/mL, while no rule offered 90% probability of error detection at level of 3.2 Log IU/mL.Conclusion: Minimizing the formation of primer-dimer and nonspecific products and concentrating the target DNA during the purification process are proposed for accurate quantitative PCR particularly when CT values are high.
کلیدواژه ها:
نویسندگان
Fatemeh Nili
Dept. of Pathology, Tehran University of Medical Sciences, Tehran, Iran
Reza Shahsiah
Dept. of Pathology, Tehran University of Medical Sciences, Tehran, Iran Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran
Farid Azmoudeh Ardalan
Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran
Mohsen Nassiri Toosi
Dept. of Gastroenterology and Hepatology, Tehran University of Medical Sciences, Tehran, Iran