Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix

ObjectiveTo 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.MethodsTwo kinds of PT samples containing living bacteria with drug matrix...

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Main Authors: FAN Yiling, LI Fang, YANG Yan, QIN Feng, LIU Hao, YANG Meicheng
Format: Article
Language:zho
Published: Shanghai Preventive Medicine Association 2022-03-01
Series:Shanghai yufang yixue
Subjects:
Online Access:http://www.sjpm.org.cn/article/doi/10.19428/j.cnki.sjpm.2022.21238
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author FAN Yiling
LI Fang
YANG Yan
QIN Feng
LIU Hao
YANG Meicheng
author_facet FAN Yiling
LI Fang
YANG Yan
QIN Feng
LIU Hao
YANG Meicheng
author_sort FAN Yiling
collection DOAJ
description ObjectiveTo 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.MethodsTwo 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.ResultsThe 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.ConclusionThe 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.
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spelling doaj.art-bdbc2354bf304639933955a59fa6de772023-01-30T10:52:56ZzhoShanghai Preventive Medicine AssociationShanghai yufang yixue1004-92312022-03-0134327928210.19428/j.cnki.sjpm.2022.212381004-9231(2022)03-0279-04Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrixFAN YilingLI FangYANG YanQIN FengLIU HaoYANG MeichengObjectiveTo 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.MethodsTwo 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.ResultsThe 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.ConclusionThe 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.http://www.sjpm.org.cn/article/doi/10.19428/j.cnki.sjpm.2022.21238drug matrixstaphylococcus aureusproficiency testhomogeneitystability
spellingShingle FAN Yiling
LI Fang
YANG Yan
QIN Feng
LIU Hao
YANG Meicheng
Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
Shanghai yufang yixue
drug matrix
staphylococcus aureus
proficiency test
homogeneity
stability
title Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
title_full Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
title_fullStr Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
title_full_unstemmed Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
title_short Sample preparation and analysis of proficiency test containing Staphylococcus aureus with drug matrix
title_sort sample preparation and analysis of proficiency test containing staphylococcus aureus with drug matrix
topic drug matrix
staphylococcus aureus
proficiency test
homogeneity
stability
url http://www.sjpm.org.cn/article/doi/10.19428/j.cnki.sjpm.2022.21238
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