The quality of antimicrobial susceptibility test discs and implications for clinical outcomes
Copyright © 2024 Elsevier Inc. All rights reserved..
Disc diffusion remains the main technique for evaluating antibiotic activity in clinical microbiology laboratories. However, the assay protocol endorsed by the FDA, DIN, and WHO is invalid. Despite decades of research and practice in this field, the quantitative quality of manufactured discs is largely unknown, potentially leading to adverse clinical outcomes. The usual standards expected for new medical devices in terms of quality control, QA, and evidence-based assessment of outcomes are almost completely lacking. Recent data indicate that a large proportion of discs do not meet the specifications, and that disc diffusion is a poor predictor of clinical outcomes. In addition, lack of harmonisation between EUCAST and CLSI, despite many years of effort, strongly suggests that there are serious flaws in these systems. This area lacks scientific rigour, which may have also contributed to adverse clinical outcomes and the emergence of antimicrobial resistance.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:109 |
|---|---|
| Enthalten in: |
Diagnostic microbiology and infectious disease - 109(2024), 1 vom: 30. März, Seite 116237 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Orszulik, Stefan T [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
AST |
|---|
| Anmerkungen: |
Date Completed 22.03.2024 Date Revised 22.03.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.diagmicrobio.2024.116237 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369182588 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369182588 | ||
| 003 | DE-627 | ||
| 005 | 20240323000957.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240302s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.diagmicrobio.2024.116237 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1341.xml |
| 035 | |a (DE-627)NLM369182588 | ||
| 035 | |a (NLM)38428376 | ||
| 035 | |a (PII)S0732-8893(24)00066-X | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Orszulik, Stefan T |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The quality of antimicrobial susceptibility test discs and implications for clinical outcomes |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 22.03.2024 | ||
| 500 | |a Date Revised 22.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Elsevier Inc. All rights reserved. | ||
| 520 | |a Disc diffusion remains the main technique for evaluating antibiotic activity in clinical microbiology laboratories. However, the assay protocol endorsed by the FDA, DIN, and WHO is invalid. Despite decades of research and practice in this field, the quantitative quality of manufactured discs is largely unknown, potentially leading to adverse clinical outcomes. The usual standards expected for new medical devices in terms of quality control, QA, and evidence-based assessment of outcomes are almost completely lacking. Recent data indicate that a large proportion of discs do not meet the specifications, and that disc diffusion is a poor predictor of clinical outcomes. In addition, lack of harmonisation between EUCAST and CLSI, despite many years of effort, strongly suggests that there are serious flaws in these systems. This area lacks scientific rigour, which may have also contributed to adverse clinical outcomes and the emergence of antimicrobial resistance | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a AST | |
| 650 | 4 | |a Antimicrobial resistance | |
| 650 | 4 | |a Antimicrobial susceptibility discs | |
| 650 | 4 | |a Outcomes | |
| 650 | 4 | |a PICO | |
| 650 | 4 | |a Quality | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 773 | 0 | 8 | |i Enthalten in |t Diagnostic microbiology and infectious disease |d 1986 |g 109(2024), 1 vom: 30. März, Seite 116237 |w (DE-627)NLM01262845X |x 1879-0070 |7 nnns |
| 773 | 1 | 8 | |g volume:109 |g year:2024 |g number:1 |g day:30 |g month:03 |g pages:116237 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.diagmicrobio.2024.116237 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 109 |j 2024 |e 1 |b 30 |c 03 |h 116237 | ||