Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
10.19428/j.cnki.sjpm.2022.21238
- VernacularTitle:含药品基质的金黄色葡萄球菌能力验证样品的制备与评估
- Author:
Yiling FAN
1
;
Fang LI
1
;
Yan YANG
1
;
Feng QIN
1
;
Hao LIU
1
;
Meicheng YANG
1
Author Information
1. NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology， Shanghai Institute for Food and Drug Control， Shanghai 201203， China
- Publication Type:Journal Article
- Keywords:
drug matrix;
Staphylococcus aureus;
proficiency test;
homogeneity;
stability
- From:
Shanghai Journal of Preventive Medicine
2022;34(3):279-282
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare samples of proficiency testing （PT） containing live Staphylococcus aureus with drug matrix in microbial PT program of drug testing， and to evaluate the laboratory capability of microbiology tests in China. Methods Two kinds of PT samples containing living bacteria with drug matrix were prepared and evaluated. The results of laboratories participated in PT program and their response to the survey questionnaire were collected and analyzed. Results The homogeneity and stability of the PT samples complied with the requirements of CNAS-CL03： 2010. Samples could be stored stably for at least 6 months at -20 ℃. Among 63 laboratories participating in PT program， 53 laboratories （84.1%） achieved satisfactory results. The satisfaction rate was 94.1% （16/17） in 17 government laboratories （27.0% of total 63 laboratories）， 81.4% （35/43） in 43 pharmaceutical quality control laboratories （68.3% of total 63 laboratories）， and 66.7% （2/3） in 3 non-government laboratories （4.8% of total 63 laboratories）， respectively. Conclusion The government laboratories performed better than pharmaceutical quality control laboratories in microbiology tests of drug， and the testing abilities of some pharmaceutical laboratories needs to be improved. The preparation and application of microbial samples in drug matrix could provide evaluation tools for drug testing laboratories in microbiology.
