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.

Author: Zulumuro Yogami
Country: Seychelles
Language: English (Spanish)
Genre: Music
Published (Last): 26 June 2010
Pages: 326
PDF File Size: 6.12 Mb
ePub File Size: 11.74 Mb
ISBN: 666-4-16585-847-8
Downloads: 69684
Price: Free* [*Free Regsitration Required]
Uploader: Akile

Reference method for broth dilution antifungal susceptibility testing of filamentous fungi, 2nd ed. Single-step extraction of fluconazole from plasma by ultra-filtration for the measurement of its free concentration by high performance liquid chromatography.

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. I agree More information. ECDC documents of relevance to antimicrobial susceptibility testing.

Clinical breakpoints for antimycobacterial agents Considering only data for dilution series prepared in Spain, no systematic difference was detected between ISO dilution and serial dilution.

ITC is a weakly basic drug pKa ca. Clinical and Laboratory Standards Institute. ISO Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Comparisons between results obtained by the tray preparation method were done by using analysis of variance ANOVA.

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.

Received Jan 20; Accepted Feb ITC precipitation after thaw-freeze cycles during transport is the most probable explanation. General Committee to Meetings, Minutes and Reports However, itraconazole trays showed a significant lack of reproducibility that was independent of which method was followed.

2076 azole compound can only be ionized and solubilized in water at a very low pH, and also 220776 studies have indicated that poor solubilization can have a significant influence on generated MIC values FLC eluted at 4. Itraconazole formulation studies of the melt-extrusion process with mixture design.

  LIVRO DE BROMATOLOGIA PDF

Calibration and validation – archive 2076 article has been cited by other articles in PMC. Example of a quick liquid chromatographic assay of itraconazole in serum. Abstract A multicenter study was conducted to assess the accuracy of the ISO standard and the serial 2-fold dilution procedures for antifungal susceptibility testing. Journal List J Clin Microbiol v. International Organization for Standards, Geneva, Switzerland. Support Center Support Center.

EUCAST: External documents

HPLC is a isoo and reproducible method for determining levels of azole components in a great variety of matrices, as has been confirmed in previous reports 12510 – 121519 – 21 Simultaneous quantification of voriconazole and posaconazole in human plasma by high-performance liquid chromatography with ultra-violet detection.

Development and validation of a high-performance liquid chromatographic assay for the determination of fluconazole in human whole blood using solid phase extraction.

Breakpoints for short incubation Expert rules and intrinsic resistance Resistance mechanisms Guidance documents Consultations – New! 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.

Relevant external documents

Susceptibility testing of moulds Projects and data submission Reference method for broth dilution antifungal susceptibility testing of yeast, 3rd ed. Evaluation of performance of antimicrobial susceptibility test devices. Steering Committee to Presentations and statistics Fluconazole trays can be accurately prepared by following ISO and serial dilution schemes.

Splitting wild type distributions.

Sitemap Search close sitemap. ISO documents of relevance to antimicrobial susceptibility testing These documents are available for uso from ISO or national standards organisations.

In this multicenter study we address this issue by comparing the concentrations of hydrophilic and hydrophobic antifungal agents, represented by fluconazole FLC and itraconazole ITCrespectively, in broth microdilution plates prepared according to the ISO standard as well as by serial dilution procedures. National Center for Biotechnology InformationU.

  FORSCOM SOLDIER RISK ASSESSMENT TOOL PDF

Our data showed similar precision and accuracy within each laboratory of the three procedures used for FLC microplate preparation. Fifty microliters of the resultant mix was injected directly into the HPLC system.

According to those standards and the ISO recommendations, the 2-fold dilutions of compounds should be performed in a multistep, rather complex, and time-consuming fashion, avoiding serial dilutions in order to prevent the risk of a systematic error being induced, for instance, by an imprecise pipette 9. Regarding serial 2-fold dilution procedures, better results were detected when FLC plates were prepared according to the hydrophilic rather than the hydrophobic way.

Acknowledgments We have no conflict of interest to declare. Prevalidation statistical design to assess analytical methods. Sensitive determination of itraconazole and its active metabolite in human plasma by column-switching high-performance liquid chromatography with ultraviolet detection. Bioanalytical method validation-a revisit with a decade of progress. The greatest discrepancy was observed for the lowest concentrations and for the dilutions prepared outside Spain and shipped for concentration determinations.

Reference method for testing the in vitro activity of ieo agents against rapidly growing aerobic bacteria involved in infectious diseases. In summary, our data suggest that microdilution trays for hydrophilic drugs such as FLC can be accurately prepared following the ISO recommendations or the serial 2-fold dilution schemes.

Published online Mar ISO Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Precision of fluconazole dilution series by dilution procedure and laboratory a.

Author: admin