WS/T 411-2024 in English

VALID

Standards for antifungal susceptibility testing of filamentous fungi Broth dilution method

Issued on:2024-04-02
Implemented on:2024-09-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $370.00
$359.00

Standard No:	WS/T 411-2024
Document status:	VALID
Title in English:	Standards for antifungal susceptibility testing of filamentous fungi Broth dilution method
Title in Chinese:	抗丝状真菌药物敏感性试验标准肉汤稀释法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2024-04-02
Implemented on:	2024-09-01
Superseding:	WS/T 411-2013 Antifungal susceptibiliy testing of filamentous fungi-Broth dilution ethod
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
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本标准规定了微量和宏量肉汤稀释法检测抗丝状真菌药物最低抑菌浓度（Minimal Inhibitory Concentration, MIC）的参考方法。
本标准适用于引起深部真菌感染的产孢丝状真菌的药物敏感性试验，包括曲霉属某些种（Aspergillus spp.）及种复合群、镰刀菌属某些种（Fusarium spp.）及种复合群、根霉属某些种（Rhizopus spp.）和毛霉目Mucorales（接合菌纲Zygomycetes）、多育节荚孢霉（Lomentospora
prolificans，原多育赛多孢霉（Scedosporium prolificans）和申克孢子丝菌复合群的菌丝相，以及
引起皮肤真菌感染的毛癣菌属某些种（Trichophyton spp.）、小孢子菌属某些种（Microsporum spp.）
和表皮癣菌属某些种（Epidermophyton spp.）。
本标准不适用于检测双相真菌如皮炎芽生菌（Blastomyces dermatitidis）、荚膜组织胞浆菌（Histoplasma capsulatum）、粗球孢子菌属（Coccidioides spp.）、马尔尼菲篮状菌（Talaromyces marneffei）及酵母样真菌的药敏试验，也不适用于检测棘白菌素类对皮肤真菌以及环吡酮、灰黄霉素或特比萘芬类对非皮肤真菌的药敏试验。

Introduction

Core changes in the standard revision

2013 version	Main updates of the 2024 version
Single CLSI standard	New EUCAST standard, Appendix E fully includes the quality control scope and breakpoints
5 categories of antifungal drugs	Expanded to 11 categories, and new dermatophyte drugs such as anidulafungin and ciclopirox
Basic ECV value	Improved ECV/ECOFF system, distinguishing wild-type from non-wild-type strains

Key technical specifications

1.

Use RPMI-1640 broth culture medium, key steps:

Water-insoluble drugs need to be dissolved in DMSO (final concentration ≤1%)
Amphotericin B detection range 0.0313-16 μg/mL
Echinocandins need to be labeled with MEC value

2. Key points for bacterial suspension preparation

Bacterial strain type	Culture conditions	OD value range
Aspergillus	35℃×7d(PDA)	0.09-0.13(530nm)
Mucorales	35℃×48h	0.15-0.17
Dermatophytes	Oatmeal medium×4-5d	Hemacytometer

Comparison of two systems for result interpretation

Key differences between CLSI and EUCAST

Voriconazole interpretation for Aspergillus fumigatus:
CLSI breakpoint: sensitive ≤0.5 μg/mL; EUCAST breakpoint: sensitive ≤0.25 μg/mL
Quality control strain culture time:
CLSI requires 48-72h, EUCAST uniformly requires 48h

Implementation suggestions

The laboratory should establish a -70℃ strain preservation system (subculture verification every 3 months)
Dermatophyte testing requires a dedicated oatmeal culture medium
ECV value reports must indicate "non-clinical efficacy prediction indicator"

More samples: JGJ 94-2008 JC/T 2453-2018 YD/T 3934-2021

Sample only — not a preview of WS/T 411-2024

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