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Fully Automated EUCAST Rapid Antimicrobial Susceptibility Testing (RAST) from Positive Blood Cultures: Diagnostic Accuracy and Implementation

At the end of September, the Journal of Clinical Microbiology published a remarkable study evaluating the accuracy and robustness of fully automated Rapid Antimicrobial Susceptibility Testing (RAST) directly from positive blood cultures (BCs). This paper – by A. Chekraoui and colleagues – will significantly impact the whole microbiology community, as the spread of multidrug-resistant organisms and the increase of resistant infections make RAST more valuable than ever. Let’s see what it’s all about!

Background

Although many positive BCs’ RAST methods have been released and rapid standardized disk-diffusion methods have been developed by EUCAST to enable susceptibility reports within 4 to 8 h and 16 to 18 h from positive BCs, the labor-intensive manual setup and the strictly defined reading time points have hampered their large-scale use in clinical microbiology laboratories. Nevertheless, shorter times for delivering accurate antimicrobial susceptibility results to provide patients with a rapid antimicrobial treatment remain one of the primary objectives to be achieved by microbiologists.

Here is where lab automation comes to help. In recent years, full laboratory automation has permitted the flexible, cost-effective, and accurate disk-diffusion method to return to the center stage and strengthen its position among other AST methods currently used in clinical microbiology laboratories.

Copan Group

So, why is this paper so important?

This study evaluates (and, spoiler alert, confirms) the accuracy and robustness of the fully automated RAST in providing fast and accurate results.

Briefly, the study was conducted in two phases.

In the first one, researchers spiked negative BCs bottles with 779 non-duplicate bacterial isolates, including various resistant phenotypes. They paid particular attention to testing a large number of clinical isolates expressing diverse resistant phenotypes, including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus, Enterococcus faecalis, and Enterococcus faecium.

In the second phase, the researchers performed a prospective clinical trial on more than 500 positive BCs processed in routine at the Bacteriology Laboratory of Geneva University Hospitals.

In both cases, fully automated disk-diffusion RAST plate preparation and S/I/R inhibition zone interpretation were performed by WASPLab and Radian at 4, 6, and 8 hrs. The results, validated by expert technologists, were assessed against EUCAST standardized disk-diffusion testing results.

What did the study find?

First, Radian interpretation demonstrated great accuracy, as the manual adjustment of the inhibition zone diameter concerned only about 5% of all tested disks.

Second, the results of the spiked BCs precisely predicted the results of the clinical trial: all antibiotics tested could be released at 4 h with high confidence, with a categorical agreement for RAST compared with the EUCAST standardized disk-diffusion test results greater than 95% for all the antibiotics tested – except for amikacin, released at 6 hrs. The only organism that posed some challenges was P. aeruginosa, and greater attention should be paid to interpreting this organism with the RAST technique.

Copan Group

To sum up

In a previous paper, Dr. Cherkaoui’s team validated Radian’s full automation of standardized disk-diffusion AST. Now, they extended the use of Radian’s fully automated solution to the EUCAST RAST method directly from positive BCs. The group established that the performance of fully automated RAST from positive BCs is robust even for detecting ESBL, carbapenemase-producing bacteria, and MRSA. Moreover, the automation enhanced the percentage of readable inhibition zones and reduced the rate of isolates categorized with technical uncertainty.

In other words, this study demonstrates that fully automated EUCAST RAST can substantially improve laboratory workflow by reducing hands-on time and removing the strong constraints linked to manual read-outs at precisely defined times, empowering clinicians to provide prompt treatment indications to patients.

If you want to explore the specific results for each organism and antibiotic, we suggest you read the full paper below: it’s Open access and contains clear tables to be consulted.

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COPAN WASP Regulatory milestones: 2022

Products transition to IVDR: completed!

We finally obtained all the certificates needed to declare the entire COPAN WASP portfolio compliant with the latest European Union In Vitro Diagnostics Regulation (IVDR).

The one-year-long process – opened last September – allows us to CE-mark all our product classes, including those that had to be evaluated and certified according to the new regulation. As a result, we can now guarantee our trusted partners and clients the continuous circulation of all our products throughout Europe without disruption.

COPAN WASP products whose IVDR compliance is covered by the certificates are classified as class A Sterile (WASP QC TSB tube), class B Medical Device Software (SOFTWARE HALO MEASURE & VISUAL, for the measurement of AST halos), and class C Medical Device Software (PhenoMATRIX, PhenoMATRIX TAG, Radian Expert System and Radian Expert System RAST, for microbial identification and antimicrobial susceptibility assessment).

Copan Group

Don’t know IVDR yet?

The new IVDR 2017/746 regulates access to the European market by classifying products into four risk classes, according to the patient and public health risks. To ensure that a product can be marketed within the EU, a Notified Body – TÜV SUD in our case – must evaluate the necessary Quality System and Technical documentation to certify that “the manufacturer has established, documented and implemented a quality management system compliant with IVDR.

510(k) FDA clearance for Colibrí: obtained!

It’s a very exciting time overseas as well: our sample preparator Colibrí™ got its second 510(k) FDA clearance! After last December’s clearance for the preparation of ID MALDI-TOF targets, now its triple vision system, accurate pipettor, and user-friendly interface became available in the US for the preparation of microbial suspension for Antimicrobial Susceptibility Testing with bioMérieux VITEK 2.

Copan Group

What’s next?

Of course, our regulatory activity is not over! As international guidelines keep evolving, we constantly work to make all our products compliant with the latest regulations. Explore below our products & certificates!

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Microbiology Time – October 2022

Microbiology Time

It’s October Microbiology Time! Look at our database to find the latest studies taking advantage of our products. This month’s top picks are:

  • An Italian study describing the presence of SARS-CoV-2 RNA in saliva samples from children attending nine schools in Rome. These results were analyzed in parallel with the trend of SARS-CoV-2 cases observed in the population of the same area, analyzed with nasopharyngeal swabs. Interestingly, the study found a different percentage of positivity in the two populations; nevertheless, the trend of SARS-CoV-2 RNA in saliva samples was consistent with that observed in the total population, suggesting that saliva is an excellent specimen to monitor SARS-CoV-2 diffusion in the population.
  • A cost-benefit analysis for laboratories and criminal justice systems about the use of 4N6FLOQSwabs versus traditional cotton swabs: although the costs and benefits may vary locally and for different practices and policies, the overall outcome of this analysis highlights that the cost of using the 4N6FLOQSwabs’ more expensive technology pales compared with the potential tangible and intangible benefits.
  • A study by A. Chekraoui and colleagues that evaluates the accuracy and robustness of a fully automated Rapid Antimicrobial Susceptibility Testing directly from positive blood cultures (BCs). This study was conducted in two phases, the first with spiked BC bottles and a prospective clinical trial including more than 500 positive BC sequentially processed in routine at the Bacteriology Laboratory of Geneva University Hospitals. The RAST results were assessed against EUCAST standardized disk diffusion testing results. What did the study find? Despite some challenges with Pseudomonas aeruginosa and suboptimal performances with piperacillin-tazobactam, ceftazidime, and cefepime at the shortest time point (6 hrs) the results of the spiked BCs precisely predicted the clinical trial results. Dr. Cherkaoui’s results establish that the performance of fully automated Rapid AST directly from positive blood culture bottles is consistently robust. The automation enhanced the percentage of readable inhibition zones and reduced the rate of isolates categorized with technical uncertainty. Summarizing, fully automated EUCAST RAST can substantially improve laboratory workflow by reducing hands-on time and removing the strong constraints linked to manual read-outs at precisely defined times.

Read the complete studies below:

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Automated Disk Diffusion AST: the next step in full laboratory automation

Copan Group
Copan Group
Copan Group

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Article Focus

Fully Automated EUCAST Rapid Antimicrobial Susceptibility Testing (RAST) from Positive Blood Cultures: Diagnostic Accuracy and Implementation

At the end of September, the Journal of Clinical Microbiology published a remarkable study evaluating the accuracy and robustness of fully automated Rapid Antimicrobial Susceptibility Testing (RAST) directly from positive blood cultures (BCs). This paper – by A. Chekraoui and colleagues – will significantly impact the whole microbiology community, as the spread of multidrug-resistant organisms and the increase of resistant infections make RAST more valuable than ever. Let’s see what it’s all about!

Copan Group

Background

Although many positive BCs’ RAST methods have been released and rapid standardized disk-diffusion methods have been developed by EUCAST to enable susceptibility reports within 4 to 8 h and 16 to 18 h from positive BCs, the labor-intensive manual setup and the strictly defined reading time points have hampered their large-scale use in clinical microbiology laboratories. Nevertheless, shorter times for delivering accurate antimicrobial susceptibility results to provide patients with a rapid antimicrobial treatment remain one of the primary objectives to be achieved by microbiologists.

Here is where lab automation comes to help. In recent years, full laboratory automation has permitted the flexible, cost-effective, and accurate disk-diffusion method to return to the center stage and strengthen its position among other AST methods currently used in clinical microbiology laboratories.

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