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WS/T 497-2017 English PDF

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WS/T 497-2017: Performance guideline for clinical laboratory diagnosis of invasive fungal diseases
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PDF similar to WS/T 497-2017


Standard similar to WS/T 497-2017

GB/T 26368   GB/T 26367   GB/T 20468   WS/T 491   WS/T 489   WS/T 493   

Basic data

Standard ID WS/T 497-2017 (WS/T497-2017)
Description (Translated English) Performance guideline for clinical laboratory diagnosis of invasive fungal diseases
Sector / Industry Health Industry Standard (Recommended)
Classification of Chinese Standard C50
Classification of International Standard 11.020
Word Count Estimation 17,159
Date of Issue 2017-01-15
Date of Implementation 2017-07-01
Issuing agency(ies) National Health and Family Planning Commission of the People's Republic of China
Summary This standard specifies guidelines for the diagnosis of invasive fungal disease clinical laboratory, including specimen collection and treatment, morphological examination, fungal culture, culture diagnosis, non-culture diagnosis and drug sensitivity test. This standard is applicable to clinical laboratories with Class II biosafety protection capabilities.

WS/T 497-2017: Performance guideline for clinical laboratory diagnosis of invasive fungal diseases


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Performance guideline for clinical laboratory diagnosis of invasive fungal diseases ICS 11.020 C50 People's Republic of China health industry standards Invasive fungal disease clinical laboratory diagnostic procedures guide 2017-01-15 Posted 2017-07-01 implementation People's Republic of China National Health and Family Planning Commission released Directory Preface Ⅰ 1 Scope 1 2 Terms and definitions 1 3 specimen collection and processing 1 4 Specimen examination 4 5 fungal culture 4 6 training diagnosis 5 7 non-cultured diagnosis 8 8 drug sensitivity test 9 References 14

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was drafted. Chinese Academy of Medical Sciences Beijing Union Medical College Hospital, Peking University First Hospital, Fudan University Affiliated Huashan Hospital. Drafters of this standard. Xu Yingchun, Li Ruoyu, Zhang Qiangqiang, Wang Yao, Wang He, Yu Jin, Guo Lina, Zhang Li, Fan Xin. Invasive fungal disease clinical laboratory diagnostic procedures guide

1 Scope

This standard specifies the invasive fungal disease clinical laboratory diagnostic procedures, including specimen collection and processing, morphological examination, fungal culture, training Breast diagnosis, non-culture diagnosis and drug sensitivity test. This standard applies to class Ⅱ biological safety preclinical clinical laboratory.

2 Terms and definitions

The following terms and definitions apply to this document. 2.1 Invasive fungal disease; IFD Fungi invade human tissues and blood, and tissue damage caused by growth and reproduction, organ dysfunction, pathological changes of inflammatory response and Pathophysiological process. According to the patient's host factors, clinical features and microbiological tests, IFD diagnosis is divided into confirmed, suspected and suspected. 2.2 Minimum inhibitory concentration minimuminhibitoryconcentration; MIC In accordance with the standard operating procedures for in vitro fungal dilution method or continuous concentration gradient drug sensitivity test, the specific culture time And temperature, the lowest concentration of drug that leads to a certain degree of macroscopic inhibition of growth of the fungus. 2.3 Dose-dependent susceptibility; MIC is sensitive to dose-dependent, given higher than the conventional dose and the maximum plasma concentration, the clinical treatment is effective. 2.4 Minimum effective concentration minimumeffectiveconcentration; MEC When Aspergillus was cultured in a culture medium containing a series of concentrations of echinocandins, mycelial change Short, round, thick the lowest drug concentration. 2.5 Breakpoint breakpoint Clinically, antimicrobial agents are classified as sensitive, resistant, intermediate or dose-sensitive to specific MIC values. Break point system outside the complex MIC value, drug resistance mechanism, antimicrobial PK/PD parameters and clinical efficacy derived, but also may change with the environment (such as the Department of Infections Bit, change of conventional administration dose, administration route and frequency change). 2.6 Digestive liquid lysissolution For pretreatment of respiratory specimens and other chemical agents, from mucolytic effect, commonly used N-acetyl-L-cysteine, 5% oxalic acid or di Mercapto-threitol and the like.

3 specimen collection and processing

3.1 blood specimen collection and processing 3.1.1 collection site disinfection 3.1.1.1 One-step method. Decontamination with clodronate gluconate for 30 seconds, or 70% isopropanol to dry naturally.

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