Frontiers in Medical Science Research, 2024, 6(7); doi: 10.25236/FMSR.2024.060709.
Haiyan Zhang1, Jian Dong2
1Research Center, Department of Basic Medicine, Zhangzhou Health Vocational College, Zhangzhou, Fujian, 363000, China
2Laboratory Department, 909th Hospital of Zhangzhou (Southeast Hospital Affiliated to Xiamen University), Zhangzhou, Fujian, 363000, China
The aim of this paper is to evaluate the performance of ABI7500 HBV-DNA detecting system to determine whether the system meets the clinical detection requirements. Referring to the document CNAS-CL02-A009: 2018 of the National Accreditation Committee for Conformity Assessment, the application of the accreditation criteria for quality and competence of medical laboratories in the field of molecular diagnosis, the in-batch precision, inter-batch precision, accuracy, linear range and anti-interference ability of the detection system were evaluated. The precision of the system is less than 3/5TEa in batch and 4/5TEa between batches. Correctness is good. The linearity of the system is good in the range of 2.61×102-2.61×108 copies/ml. The results of high and median serum tests are not easily interfered by three substances: bilirubin, hemoglobin and triglyceride. The low-value serum tests are more susceptible to the interference of these three substances. The ABI7500 HBV-DNA detection system has good performance evaluation results and can meet the requirements of clinical detection.
HBV-DNA; ABI7500; precision; correctness; linearity; interference test
Haiyan Zhang, Jian Dong. Performance Evaluation of HBV-DNA Detection by ABI7500 Polmerase Chain Reactor and Analysis of Anti-interference Ability. Frontiers in Medical Science Research (2024), Vol. 6, Issue 7: 77-83. https://doi.org/10.25236/FMSR.2024.060709.
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