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Quality Control Working Group

Publications and source records attributed to Quality Control Working Group.

11 recordsLinked to original sources
PubMed2005

Quality control guidelines for testing gram-negative control strains with polymyxin B and colistin (polymyxin E) by standardized methods.

An eight-laboratory study addressed the urgent need for quality control (QC) ranges for susceptibility determination when testing colistin (polymyxin E) and polymyxin B, two polycationic peptide antimicrobial agents, against multidrug-resistant gram-negative bacilli. For Escherichia coli ATCC 25922l, the QC ranges were as follows: for colistin, 0.25 to 1 microg/ml (11 to 17 mm), and for polymyxin B, 0.25 to 2 microg/ml (13 to 19 mm). For Pseudomonas aeruginosa ATCC 27853, the QC ranges were as follows: for colistin, 0.25 to 2 microg/ml (11 to 17 mm), and for polymyxin B, 0.25 to 2 mug/ml (14 to 18 mm). More than 97% of all reported QC results were within these proposed ranges.

Anti-Bacterial Agents↗
PubMed2004

MIC quality control guidelines for doxycycline when testing gram-positive control strains by the reference methods.

With emerging resistance to fluoroquinolones, there arises a need to establish quality control (QC) guidelines for doxycycline, an effective alternative for treating various community-acquired respiratory tract infections. This multicenter study was performed to establish QC guidelines for susceptibility testing those Gram-positive QC organisms against doxycycline. The proposed three or four log2 dilution MIC ranges included 100.0% of the doxycycline MIC values reported.

Anti-Bacterial Agents↗
PubMed2004

Disk diffusion quality control guidelines for NVP-PDF 713: a novel peptide deformylase inhibitor.

NVP-PDF713 is a peptide deformylase inhibitor that has emerged as a candidate for treating Gram-positive infections and selected Gram-negative species that commonly cause community-acquired respiratory tract infections. This report summarizes the results of a multi-center (seven participants) disk diffusion quality control (QC) investigation for NVP PDF-713 using guidelines of the National Committee for Clinical Laboratory Standards and the standardized disk diffusion method. A total of 420 NVP-PDF 713 zone diameter values were generated for each QC organism. The proposed zone diameter ranges contained 97.6-99.8% of the reported participant results and were: Staphylococcus aureus ATCC 25923 (25-35 mm), Streptococcus pneumoniae ATCC 49619 (30-37 mm), and Haemophilus influenzae ATCC 49247 (24-32 mm). These QC criteria for the disk diffusion method should be applied during the NVP-PDF 713 clinical trials to maximize test accuracy.

Amidohydrolases↗
PubMed2004

Quality control guidelines for BAL9141 (Ro 63-9141), an investigational cephalosporin, when reference MIC and standardized disk diffusion susceptibility test methods are used.

BAL9141 is a novel cephalosporin with a broad spectrum of activity, including activity against methicillin-resistant staphylococci. This multicenter study was performed to establish quality control (QC) guidelines for susceptibility testing of BAL9141 in phase 3 clinical trials and after U.S. Food and Drug Administration approval. The proposed 3 or 4 log(2) dilution MIC ranges encompass 97.8 to 100.0% of reported results, while the proposed 7- to 9-mm-zone-diameter QC ranges included 95.2 to 99.4% of the participant-reported disk diffusion results.

Cephalosporins↗
PubMed2003

Re-evaluation of quality control guidelines for gatifloxacin and garenoxacin (BMS284756) when susceptibility testing Haemophilus influenzae and Streptococcus pneumoniae.

An eight laboratory M23-A2 quality control (QC) study was performed for the re-evaluation of gatifloxacin, a new fluoroquinolone, using disk diffusion tests against Streptococcus pneumoniae ATCC 49619. The study also re-evaluated garenoxacin, a novel investigational des-F(6)-quinolone, using disk diffusion tests against S. pneumoniae ATCC 49619 and broth MIC for Hemophilus influenzae ATCC 49247. The gatifloxacin zone diameter results for S. pneumoniae did not indicate a need for QC range modification (26-34 mm; 98.3% of results); however, the garenoxacin zone diameters did demonstrate a need for a minor modification (1 mm; 26-34 mm; 96.3% of reported results). The broth MIC results for H. influenzae showed that 83.1% of the results were at the upper limit of the current range (0.008 microg/ml) published by the National Committee for Clinical Laboratory Standards (NCCLS). The proposed correction could either be 0.002-0.015 microg/mlor 0.004-0.015 microg/ml, each encompassing 100.0% of reported results (prior and current studies). All MIC results for control drugs, levofloxacin and moxifloxacin (disks) or gatifloxacin and clarithromycin (MIC), were within published NCCLS ranges.

Anti-Infective Agents↗
PubMed2001

Assessment of BMS284756 MIC and 5-microg disk diffusion quality control studies tested against seven American type culture collection strains.

BMS284756 is a novel des-fluoro(6)-quinolone with antimicrobial activity similar to recently developed fluorinated quinolones. The purpose of this investigation was to determine the appropriate disk diffusion and MIC quality control (QC) ranges for BMS284756 when used against commonly tested QC strains (M23-A2). The BMS284756 5-microg disk content was tested against Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853, Hemophilus influenzae ATCC 49247, Streptococcus pneumoniae ATCC 49619 and Staphylococcus aureus ATCC 25923. In addition, Enterococcus faecalis ATCC 29212 and S. aureus ATCC 29213 were evaluated by the broth microdilution method. Seven laboratories tested 2 disk lots on 3 agar media or 3-4 broth lots over a 10 day period. A total of 420 zone diameter values and 210 or 280 MIC values per organism were generated. The following disk diffusion and MIC QC ranges were suggested for BMS284756 and the seven QC strains: E. coli ATCC 25922 (28-35 mm/0.004-0.016 microg/mL), E. faecalis ATCC 29212 (0.03-0.25 microg/mL), S. aureus ATCC 25923 (30-36 mm), S. aureus ATCC 29213 (0.004-0.016 microg/mL), P. aeruginosa ATCC 27853 (19-25 mm/0.5-2 microg/mL), H. influenzae ATCC 49247 (33-41 mm/0.002-0.008 microg/mL), S. pneumoniae ATCC (26-33 mm/0.016-0.06 microg/mL). The proportion of participant results observed within the proposed ranges was 97.4-98.8% and 94.6-100% for the disk diffusion and MIC tests, respectively.

Anti-Infective Agents↗
PubMedDate not supplied

Validation of cefditoren MIC quality control ranges by a multi-laboratory study (2001).

The potency of cefditoren has been well documented to include broad coverage against both Gram-positive and Gram-negative organisms including species causing community-acquired respiratory tract infections. The accuracy of in vitro test results has been questioned due to debate over inconsistencies in quality control (QC) recommendations published by the National Committee for Clinical Laboratory Standards (NCCLS). Previous studies have recommended conflicting and generally broad MIC dilution ranges for several commonly used QC organisms. This study used NCCLS recommended guidelines to re-evaluate the MIC ranges using a seven laboratory M23-A2 design. The results of this multi-laboratory investigation leads to the proposal of the following QC range recommendations for cefditoren: Streptococcus pneumoniae ATCC 49619 (0.016-0.06 microg/mL); Haemophilus influenzae ATCC 49247 (0.06-0.25 microg/mL); Escherichia coli ATCC 25922 (0.12-1 microg/mL); and Staphylococcus aureus ATCC 29213 (0.25-1 microg/mL). These proposed ranges validate those suggested previously for E. coli and the problematic H. influenzae, but a three log(2) dilution range may be sufficient for S. aureus and S. pneumoniae.

Cephalosporins↗