ISO 20776 PDF

ISO. First edition. Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation. ISO () Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of. Buy ISO , Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices, Part 1, at CLSI.

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Relevant external documents

When there are no breakpoints? Open in a separate window. Example of a quick liquid chromatographic assay of itraconazole in serum. Sitemap Search close sitemap.

An optimized analytical method of fluconazole in human plasma by high-performance liquid chromatography with ultraviolet detection and its application to a bioequivalence study. Susceptibility testing of pathogenic fungi with itraconazole: Susceptibility testing of yeasts The presence and concentration of FLC or ITC in each well was determined by comparing the chromatographic signal peak area, retention time, and a UV spectral pattern of between and nm from the sample and from standard solutions.

ISO documents of relevance to antimicrobial susceptibility testing These documents are available for 2076 from ISO or national standards organisations.

Projects and data submission Microtiter lso were prepared according to the ISO standard and by serial dilution procedures recommended for preparation of trays of both hydrophilic and hydrophobic drugs 9 However, preparation of ITC trays for antimicrobial susceptibility testing AST microdilution tests is associated with a significant lack of reproducibility, particularly after freezing and shipping, independent of which dilution method was followed.


Published online Mar Previous versions of documents AST of mycobacteria Clinical and Laboratory Standards Institute.

Journal List J Clin Microbiol v. Where clinical data is lacking! Rationale documents for antifungals Simultaneous quantification of voriconazole and posaconazole in human plasma by high-performance liquid chromatography with ultra-violet detection. Susceptibility testing of moulds Clinical breakpoints for antimycobacterial agents Quality control procedures of AST should be implemented in order to minimize the inaccuracy of dilution methods and lack of reproducibility when hydrophobic compounds such as ITC are tested.

Abstract A multicenter study was conducted to assess the accuracy 207766 the ISO standard isso the serial 2-fold dilution procedures for antifungal susceptibility testing. Furthermore, previous studies have demonstrated a much higher interlaboratory variation in MIC results for quality control strains for itraconazole than for flucytosine and fluconazole 6 – 8.

ECDC documents of relevance to antimicrobial susceptibility testing. Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases.

Received Jan 20; Accepted Feb International Organization for Standards. Single-step extraction of fluconazole from plasma by ultra-filtration for the measurement of its free concentration by high performance liquid chromatography.


Fifty microliters of the resultant mix was injected directly into the HPLC system.

EUCAST: External documents

Evaluation of performance of antimicrobial susceptibility test devices. Support Center Support Center. Stock solutions and microdilution wells were tested 27076 concentration of antifungal agent using high-performance liquid chromatography HPLC methods previously described 125. By using this website, you agree to its use of cookies. ITC is a weakly basic drug pKa ca. Acknowledgments We have no conflict of interest to declare. 207766 trays can be accurately prepared by following ISO and serial dilution schemes.

However, itraconazole trays showed a significant lack of reproducibility that was independent of which method was followed. This azole compound can only be ionized and solubilized in water at a very low pH, and also earlier studies have indicated that poor solubilization can have a significant influence on generated MIC values Thus, ITC data obtained from trays prepared by the Inn Austria participant were excluded from the analysis since tray wrappings showed evidence of defrosting and spillage; also, concentrations of dilutions prepared in Denmark were unacceptably different from the target concentrations.