YY/T 1728-2021Clinical 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 (English PDF)

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.

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.