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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This article has been cited by other articles in PMC. By using this website, you agree to its use of cookies. Simultaneous quantification of voriconazole and posaconazole in human plasma by high-performance liquid chromatography with ultra-violet detection. 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.

Rationale documents for antifungals 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. Steering Committee to Presentations and statistics Single-step extraction of fluconazole from plasma by ultra-filtration for the measurement of its free concentration by high performance liquid chromatography. HPLC is a sensitive and reproducible method for determining levels of azole components in a great variety of matrices, as has been confirmed in previous reports 12207610 – 121519 – 21 Example of a quick liquid chromatographic assay 2077 itraconazole in serum.

Journal List J Clin Microbiol v. Prevalidation statistical design to assess analytical methods. Since the hydrophilic growth medium RPMI-G at pH 7 has been selected for testing in vitro antifungal susceptibility, it was important to describe the lack of proper solubility of this compound. These documents are available for purchase from ISO or national standards organisations.

Bioanalytical method validation-a revisit with a decade of progress. Breakpoints for short incubation Expert rules and 2776 resistance Resistance mechanisms Guidance documents Consultations – New!

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Relevant external documents

Microtiter plates were prepared according to the ISO standard and by serial dilution procedures recommended for preparation of trays of both hydrophilic and hydrophobic drugs 9 Susceptibility testing of yeasts A multicenter study was conducted to assess the accuracy of the ISO standard and the serial 2-fold dilution procedures for antifungal susceptibility testing.

Sitemap Search close sitemap. Susceptibility testing of ios 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.

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility testing devices.

EUCAST: External documents

While this is the gold standard for preparation of dilution series, the question has risen if modern pipettes are sufficiently precise to allow dilution series to be prepared as serial dilutions without a loss of accuracy. The greatest discrepancy was observed for the lowest concentrations and for the dilutions prepared outside Spain and shipped for concentration determinations. ECDC documents of relevance to antimicrobial susceptibility testing. Precision of itraconazole dilution series by procedure and laboratory a.

Reference method for broth dilution antifungal susceptibility testing of filamentous fungi, 2nd ed.

Fifty microliters of the resultant mix was injected directly into the HPLC system. Previous versions of documents AST of mycobacteria Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases. Development and validation of a high-performance liquid chromatographic assay for the determination of fluconazole in human whole blood using solid phase extraction.

Stock solutions and microdilution wells were tested for concentration of antifungal agent using high-performance liquid chromatography HPLC methods previously described 125.

Susceptibility testing of pathogenic fungi with itraconazole: FLC eluted at 4. 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.

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Evaluation of performance of antimicrobial susceptibility test devices. Please review our privacy policy. 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.

ISO Clinical laboratory 200776 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 information Article notes Copyright and License information Disclaimer.

However, preparation of ITC trays for antimicrobial susceptibility testing AST microdilution tests is associated with oso significant lack of reproducibility, particularly after freezing and shipping, independent of which dilution method was followed. General Committee to 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 However, itraconazole trays showed a significant lack of reproducibility that was independent of which method was followed.

Projects and data submission Thus, serial dilution, which is attractive due to its simplicity, may be appropriate.

All statistical analyses were done with the statistical package PAWS statistics Notably, although relative errors were greater for the lowest concentrations, we did not observe an increasing inaccuracy when performing serial dilutions compared to dilutions performed following the ISO procedure as would have been expected if the precision of modern pipettes 2776 been insufficient.