Performance evaluation of ABI 7300 real-time fluorescent quantitative PCR
10.3969/j.issn.1673-4130.2015.04.026
- VernacularTitle:ABI7300实时荧光定量PCR仪的性能评估
- Author:
Wei CHAO
- Publication Type:Journal Article
- Keywords:
real-time fluorescent quantitative PCR analyzer;
performance evaluation;
HBV-DNA
- From:
International Journal of Laboratory Medicine
2015;(4):494-495
- CountryChina
- Language:Chinese
-
Abstract:
Objective To participate in the recognition of medical laboratory and to evaluate the performance of the instruction, we assess the performance of ABI 7300 real-time fluorescent quantitative PCR instrument.Methods According to United States of America Clinical and Laboratory Standards Institute(CLSI),assess the precision,accuracy,sensitivity and linearity of HBV-DNA detection result in ABI 7300 fluorescence quantitative PCR instrument.Results The Intraassay coefficient of variation is 2.38%-4.61%,and interassay coefficient of variation was 3.87%-5.33%,both achieve the performance analysis standard of gene ampli-fication test project regulated by Medical Laboratory Quality and Competence Accreditation Criteria.Accuracy:the overall mean bias in 2011 Ministry of Health EQA results was 2.14%,which met the quality assessment requirements of the ministry of health. Functional sensitivity:the CV of 100 IU/mL detection limit concentration was close to 20%,which accords with the The limit of detection of the kit;Linear:the correlation coefficient r2 is 1.0,linear relationship met the requirements.Conclusion The perform-ance index of ABI 7300 real-time fluorescent quantitative PCR instrument is accuracy,and it can provide fast,accurate reports for clinical department.
