YY/T 1728-2021 English PDF

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YY/T 1728-2021: Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1728-2021	434	Add to Cart	4 days	Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases	Valid

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Basic data

Standard ID: YY/T 1728-2021 (YY/T1728-2021)
Description (Translated English): Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 23,230
Issuing agency(ies): State Drug Administration

YY/T 1728-2021: Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious 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.
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standards Clinical laboratory testing and in vitro diagnostic system Yeast-like fungal antibacterial agents associated with infectious diseases Reference method for in vitro activity detection (ISO 16256.2012, IDT) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅰ Introduction Ⅱ 1 Scope 1 2 Terms and definitions 1 3 Test procedure 3 3.1 Overview 3 3.2 Medium 4 3.3 Antifungal agents 4 3.4 Storage of microdilution plates 7 3.5 Preparation of inoculum solution 7 3.6 Inoculation of microdilution plates 8 3.7 Incubation of microdilution plates 8 3.8 MIC result reading 8 3.9 Interpretation of MIC value 9 4 Quality Control (QC) 9 Appendix A (informative appendix) RPMI-1640 medium 13 Appendix B (informative appendix) 0.5 McDonnell's barium sulfate turbidity standard 16 Appendix C (informative appendix) Visual MIC interpretation procedure Acceptable interpretation time for MIC interpretation 17 Reference 18

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the translation method equivalent to ISO 16256.2012 "Clinical laboratory testing and in vitro diagnostic system infectious diseases related Reference method for in vitro activity detection of yeast-like fungal antibacterial agents. This standard has made the following editorial changes. ---In order to facilitate the understanding of the terms, some notes have been added. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). The main drafting organizations of this standard. Beijing Medical Device Inspection Institute, Shandong Medical Device Product Quality Inspection Center, Thermo Fisher Scientific Technology (China) Co., Ltd. The main drafters of this standard. Bi Chunlei, Yang Zhong, Wang Wenqing, Qin Dongli, Hong Mei.

Introduction

The in vitro susceptibility test of antibacterial agents is usually for microorganisms that may cause disease, especially those that are considered to be resistant to frequently used antibacterial agents. A microbial species that may exhibit acquired drug resistance. The test is used in drug resistance monitoring, susceptibility epidemiological research and new antibacterial The comparison between the antibacterial agent and the existing antibacterial agents is also very important. The dilution method is often used to determine the minimum inhibitory concentration (MIC, minimuminhibitoryconcentration) of antibacterial agents, and represents Reference method for fungal agent susceptibility test. The MIC method is usually used for drug resistance monitoring, comparative research of new antimicrobial agents for research and registration purposes. Research, establishment of susceptibility for microorganisms with unclear results from routine tests, tests for microorganisms whose routine tests may be unreliable, and clinical needs Circumstances to quantify the results. In the dilution method test, by detecting microorganisms in a series of agar plates containing serially diluted concentrations of antibacterial agents (Agar dilution method) or in the broth (broth dilution method) can produce visible growth. The minimum inhibitory concentration (MIC value) of an antibacterial agent refers to the ability to inhibit a specific The minimum concentration (in mg/L) of the antimicrobial agent at which microbes can grow visible to the naked eye or optically measurable. MIC value guides clinicians The teacher understands the susceptibility of microorganisms to antibacterial agents, so as to help them make treatment decisions. Since the method used may affect the test results, in order to To ensure the reproducibility of results in the laboratory and between the laboratory, the laboratory needs to carry out strict quality control and standardization. Broth dilution method The test result (MIC value) is within one-fold dilution of the true end point of the MIC (that is, ±1 hole or tube of the multiple-dilution series). Reproducible. The broth dilution method is to inoculate a series of containers of the same volume of broth containing increasing concentrations (usually twice) of antibacterial agents. Quantitative microbiological technology. The broth microdilution method refers to a broth dilution test performed on a microdilution plate. The reference method described in this standard is applicable to the detection of pure cultures of yeast-like fungi. Broth micro-dilution method described in this standard And the methods used by the Clinical and Laboratory Standardization Institute (CLSI) [1] and the European Committee for Antimicrobial Susceptibility Testing (EUCAST) [2] Essentially equivalent. These methods show that the fluconazole MIC given is actually the same, if not exactly the same, the biggest difference Within 2mg/L [3]. Research with various other antifungal agents has been planned or in progress. Hope to use this standard to carry out new Research on antifungal agents, or as a reference method for comparing the MIC results given by diagnostic equipment, should be based on the determination of MIC readings. Whether the result is visual inspection (CLSI method) or photometric method (EUCAST method) to choose which program option to use, at any time In either case, the details of the selected procedure must be strictly followed. Clinical laboratory testing and in vitro diagnostic system Yeast-like fungal antibacterial agents associated with infectious diseases Reference method for in vitro activity detection Warning---The use of this standard may involve hazardous materials, operations and equipment. This standard does not intend to state the use of this standard There are security issues. Before using this standard, users are responsible for establishing appropriate safety and health measures and determining the applicability of regulatory restrictions.

1 Scope

This standard describes methods for testing the sensitivity of yeast-like fungal antifungal drugs, including Candida and Cryptococcus neoformans, which cause infections. bacteria. The reference method described here has not been used for yeast-type studies of biphasic fungi, such as Blastomyces dermatitis and/or histoplasma capsularis pods Film variants. In addition, the standardization of detection of filamentous fungi (mold) involves several other issues that are not addressed in the current procedures. Filamentous fungus broth The dilution method antifungal drug susceptibility test reference method has been developed. The available files are CLSIM38 and EUCASTE.DEF 9.1 [4-8]. The broth microdilution reference method described in this standard can be achieved in one of two ways. The first way is to determine the MIC by the naked eye. (CLSI method) [1], the second way is to determine MIC by photometric method (EUCAST method) [2]. MIC reflects under specified test conditions The activity of the drug, and the purpose of clinical management should be explained in consideration of other factors, such as the pharmacology of the drug or the mechanism of antifungal resistance. The interpretation of MIC results can be divided into "sensitive" (S), "dose-dependent sensitive" (S-DD), "intermediary" (I), "non-sensitive" (NS) or "resistant" (R). In addition, MIC distribution can be used to determine wild-type or non-wild-type fungal communities. The clinical interpretation of the MIC value is outside the scope of this standard. The explanatory classification breakpoints corresponding to the CLSI method and the EUCAST derivative method can be found in the latest interpretation table provided by the corresponding institution [2,9]. Push It is recommended to compare routine sensitivity test methods or diagnostic test equipment with this reference method to ensure the comparability and comparability of results during verification or registration. reliability.

2 Terms and definitions

The following terms and definitions apply to this document. 2.1 Antifungal agent A class of biologically derived, semi-synthetic or synthetic substances that can inhibit or kill fungi and can be used for anti-infective treatment. Note. Disinfectants, sterilants and preservatives are not within the scope of this definition. 2.2 Antifungalagents-properties 2.2.1 Potency The proportion of the active part of the test substance is determined by comparing the biological analysis method with the reference substance of the same substance. Note. The potency can be expressed as the mass fraction of the components in the test substance in milligrams per gram (mg/g), or the active content in international units per gram (IU/g), or in terms of volume. Fraction or mass fraction of the percentage content or the number of moles per liter of substance concentration. 2.2.2 Concentration The amount of antifungal agent in a specified volume of liquid. ......

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