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Microbiology Time – November 2022

Microbiology Time

Many were the studies taking advantage of our products published last month. It was a tough choice, but here are the top three papers:

  • Another prospective cost-benefit analysis by Dr. Budowle and his team, which compared our 4N6FLOQSwabs® against cotton swabs with a “Monte Carlo simulation.” Like last October’s paper, the slightly higher cost of using a nylon swab paled compared with the potential tangible and intangible benefits of the device, providing a sounder basis for forensic laboratories to request additional funds to support the implementation of this new technology.
  • The second international study aims to explore and characterize the microbiota of the healthy eye. With a metagenomics approach, the researchers found that the eye microbiome is a low-diversity population, with most of the analyzed samples highly enriched with Staphylococcus. By introducing the term eye community state type – to stratify the different profiles of bacterial communities that coexist together in a healthy eye – and identifying nine distinct community profiles, Borroni et al. propose that a better understanding of the healthy eye microbiota could improve disease diagnosis and personalized eye medicine.
  • The last study – from the US – evaluates the pros and cons of home-based self-sampling kits for the screening for anal cancer caused by an HPV infection. The study randomized men who have sex with men and transgender persons to receive a mailed self-sampling kit or attend a clinic for screening. The researchers assessed temperature, freeze-thaw cycles, the presence of fecal matter, and days in an uncontrolled environment of every sample. By analyzing samples with HPV genotyping, they found that more than 90% of specimens were adequate for the analysis and that samples inadequacy was not associated with temperature, freeze-thaw cycles, or transit time. On the contrary, the presence of fecal matter contamination predicted specimen inadequacy. The team concludes that environmental conditions do not affect specimen adequacy and suggest self-collection as a valuable tool for screening for HPV-induced anal cancer.

 

Read the complete studies below:

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Radian® RAST: Pushing Antimicrobial Susceptibility Testing at full speed

News

Although part of the 2020 data is unavailable because of the pandemic, the data at our disposal show an alarming increase in resistant infections – at least +15% from 2019 to 2020.

Which infections are we talking about? Of course, blood infections, but not only. Intestinal, respiratory, and sexual infections saw a dramatic increase as well.

Introducing Radian RAST

AST results are essential to selecting the best antimicrobial therapy for each patient. Today more than ever, the reduction of the AST turnaround time remains one of the primary objectives to be achieved by microbiologists, to provide patients with rapid antimicrobial treatment.

Copan’s Radian® has already permitted the flexible, cost-effective, and accurate disk-diffusion method to shine among other AST methods, but this wasn’t enough. Integrating EUCAST Rapid AST Rules (RAST) into the automated workflow, last November we brought Radian® to be the first fully automated platform to provide accurate therapy indications from positive hemoculture with just a 4-hours incubation.

During the last months, we worked to bring Radian® advantages even further: accelerate AST also for critical samples other than positive blood cultures.

Well, we’ve done it!

We expanded the range of samples that can be analyzed with Radian® Rapid AST, to ensure accurate therapy indications with as little as a four-hour incubation.

Radian RAST grants microbiologists an unparalleled fast diagnostic assessment, directing each patient toward an early intervention with targeted antimicrobial therapy like no other AST automation available today.

Radian® Expert System RAST

The updated Expert System is Radian RAST’s core. It offers the possibility to add custom breakpoints and rules applied at different custom samples other than blood culture and at different custom incubation time slots.

Learn more on Radian’s page:

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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!

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.

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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).

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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.

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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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