Beta-D-Glucan is the key fungal biomarker, but complex kit protocols and the cost/test of low numbers have limited the adoption of in-house BD Glucan testing despite referring samples to outside laboratories building in delays and costs. Both cost/test issues and complex protocols have now been removed by the introduction of a fully automated system – FACIS.
The FACIS – Fully Automatic Chemiluminescence Immunological System – can process a Beta-D-Glucan serum or BAL sample in 40 minutes. Fully automatic, the only operator manipulations are to load the sample and press go! Pre-treatment, reagent distribution, controls? and data analysis are all automated.
FungiXpert Beta-D-Glucan (CLIA) used with FACIS doesn’t penalise single or small batch testing. The reagent cost-per-test is only £20 for single sample or multiple sample runs.
IMPORTANTLY: Introducing antifungal stewardship has been shown to reduce annual antifungal expenditure by 20-30%. In one UK university hospital this equated to a saving of £250,000 per annum.
It is established that both patients and hospital budgets benefit from antifungal stewardship. Antifungal Stewardship has shown significant financial benefits in publications from St Georges and Oxford with reductions in annual antifungal expenditure of 20-30% equating to six-figure savings. These benefits were shown to be even more significant when antifungal stewardship was backed up by Beta-D-Glucan in a publication from Manchester.
Integrated individual reagents and consumables. Convenient and avoid waste.
The purchase of the FACIS equipment was calculated to be self-funding from the laboratory budget alone in under 18 months at a hospital submitting 50 samples per month Beta-D-Glucan.
Antifungal Susceptibility testing EUCAST or CLSI?
Comparison shows that there is a significant variability in susceptibility pattern and consequently on use of antifungals in daily practice, depending on the choice of commercial system.
An article1, published in May 2021, raised questions about the differences between EUCAST and CLSI interpretations of broth microdilution susceptibility tests. The article compared the Sensititre YeastOne product, based on CLSI, and the MICRONAUT-AM based on EUCAST.
KEYNOTES
These findings show that there is a significant variability in susceptibility pattern and consequently on use of antifungals in daily practice, depending on the choice of commercial system.
The important statistically significant differences in test results between both systems do however expose a significant impact on local antifungal susceptibility patterns, on antifungal use and even on in-hospital empirical guidelines when one or the other commercial system is implemented in the clinical laboratory.
Sensititre minimal inhibitory concentrations (MICs) were systematically higher than MICRONAUT MICs for all anti-fungals, except for itraconazole. CLSI clinical breakpoints (CBPs) and epidemiological cut-off values (ECVs) were used for Sensititre MICs while for MICRONAUT the EUCAST CBPs and ECVs were used.
Sensititre minimal inhibitory concentrations (MICs) were systematically higher than MICRONAUT MICs for all antifungals, except for itraconazole’.
In this study, it was not possible to evaluate which colorimetric broth microdilution method was more correct.
BioConnections introduced MICRONAUT-AM into the UK in 2014. We now have 20 hospitals using this product in-line with EUCAST guidelines that ‘It is recommended that broth micro dilution is used to perform antifungal susceptibility testing of yeasts and moulds’. The introduction of antifungal stewardship requires timely access to fungal biomarkers and susceptibility testing.
The MICRONAUT-AM system features susceptibility testing of up to 9 antimycotics in up to 11 concentrations following the MIC procedure. It contains highly effective antifungal agents like anidulafungin, caspofungin and posaconazole. Addition of an AST indicator and the included negative control simplify the visual as well as the photometrical reading.
The MICRONAUT-RPMI medium improves the growth of the yeast and cryptococci delivering interpretation according to EUCAST guidelines after 24-48 hours for yeast and 48-72 hours for cryptococci.
MICRONAUT broth microdilution plates have been evaluated for use with Aspergillus in a UK laboratory.2
References
1 J. Fungi 2021, 7, 356. https://doi.org/10.3390/jof7050356
2 Medical Mycology doi: 10.1093/mmy/myaa020
Galactomannan CLIA - removes the heating step
The world’s first and only quantitative product for the early detection of invasive Aspergillosis in human serum and BAL fluid based on chemiluminescence with an integrated reagent strip. Available for use on FACIS - Full-Automatic Chemiluminescence Immunoassay System. All sample treatment, reagent additions, reading and interpretation carried out automatically. No heat pre-treatment required.
• All-in-one design reduces the risk of contamination
• Ready-to-use format saves time and money
• Refrigerated storage is easy and economical
• Online Certificate of Analysis provides detailed strain information
• Traceability to reference cultures ensures authenticity
• Technical Support experts available for guidance
• Strains are three passages or fewer from the reference culture
• FDA listed and CE Marked as an In Vitro Diagnostic (IVD) Medical Device
Applications:
• Culture purposes
• Daily QC
• Verification and Validation
• QC of diagnostic systems and assay kits
• QC of Antimicrobial Susceptibility Test
Package Details:
• All-in-one design including a lyophilized microorganism pellet, ampoule of hydrating fluid and inoculating swab
• Packs of two or six
• Instructions for Use
• Also available in QC Sets and Panels (each QC Set and Panel is designed to contain the QC strains recommended by the instrument manufacturer or regulatory standard)
We hope you find this information useful. If you would like any additional information or guidance, please get in touch - we would be delighted to assist and show you more. We are about to add B-D-glucan and RT-PCR to our mycology range, please take this opportunity to register your interest.
The BioConnections Team
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