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MMDx™ – Sepsitest and MicroDx: Identify Bacteria And Fungi Without Culture and Improve Patient Management With Molecular Diagnostics For Targeted Treatment

16 November 2023

VH Bio’s supply partner, Molzym, outlines how MMDx removes limitations of culture for microbe detection and outlines how laboratories can gain confidence in the identification of pathogens in time-sensitive cases:

 

How Can you Identify Bacteria and Fungi Without Culture?

Is your work in the lab affected by the limitations of culture for microbe detection?

Have you ever wished for a reliable and quicker identification of bacteria and fungi?

When it comes to the identification of bacteria and fungi from ill patients’ clinical samples, lab specialists are facing several challenges:

  1. When standard culture methods do not provide relevant information within 24 hours, results are generally not available before an average of 3 to 7 days or at all. This high rate of culture-negative results is usually due to prior antimicrobial therapy, that would inhibit culture growth, or to the presence of fastidious or non-growing microorganisms.
  2. Molecular approaches have become popular and are used for clinical diagnostics. However, most common panel-based or in-house molecular tests are limited by (a) the identification of only a few microorganisms, (b) validated sample material, (c) high excess of human DNA and (d) reagent-borne contaminations that may reduce their sensitivity.

The Solution: MMDx™

Molzym has developed a unique broad-range approach to identify bacteria and fungi directly from clinical samples, in only a few hours, enabling every lab to provide clinically relevant information in cases of culture-negative samples:

  • Broad-range “in”: one test / one protocol for a wide range of clinically relevant samples, be it fluids, tissues or swabs.
  • Broad-range “out”: one test for the accurate identification of > 1300 microorganisms, with the possibility to resolve single or polymicrobial infections.

Culture independent identification of bacteria and fungi from any sample type, body fluids, tissues, or swabs, with one protocol is possible with Molzym’s molecular diagnostic technology that:

  • combines human DNA depletion and isolation of pure microbial DNA
  • targets the 16S and 18S rRNA genes for broad detection of bacterial and fungal DNA
  • increases the sensitivity by using ultra-pure DNA-free PCR reagents
  • allows to identify up to 1 300 microorganisms by Sanger sequencing
  • includes the detection of common but also rare, fastidious, and non-growing infectious pathogens.

The clinical diagnostic workflow can be explained in 4 steps:

Figure 1. Molzym Molecular Diagnostic Workflow

After 4 hours, including manual or automated microbial DNA extraction and broad-range 16S/18S PCR amplification, initial results indicate if bacteria or fungi are present in the sample. Positive amplicons are applied to Sanger sequencing and the pathogens are identified by BLAST search.

Discover Molzym’s Diagnostic Workflow in 60 seconds:

MMDx™ – Clinical Benefit

  • High positivity in culture-negative samples, increasing the diagnostic capacity of the lab on average x2, when MMDx™ is used in combination with culture methods. Indeed, 40% to 67% MMDx™-positive, culture-negative results have been reported in a series of publications [1] covering a wide spectrum of clinical applications, such as:
  • Bloodstream infections, Orthopaedic infections, Infective Endocarditis, Bacterial Meningitis, or other serious pathogen infections filling up Hospital beds.
  • Such broad pathogen identification capacity has been shown to contribute to adapted antimicrobial therapy (from broad to narrow spectrum, or discontinuation), saving days of unnecessary antibiotics, thus improving patient outcomes, and contributing to the fight against antimicrobial resistance [1].

To learn more, read Molzym’s White Paper:

Clinical Applications of Molzym’s Broad Spectrum Molecular Diagnostics

 

How Can You Improve Patient Management With Molecular Diagnostics For Targeted Treatment?

Discover the clinical added-value brought to laboratory specialists and physicians while using Molzym diagnostic technology to detect and identify infectious microorganisms from various clinical specimens.

Learn how to improve patient management with broad-range molecular diagnostic, in the context of sepsis, bone & joint infections, infective endocarditis or bacterial meningitis:

Do you often get negative culture results in severely ill patients with suspected bacterial or fungal infections?

Would you like to gain confidence in the identification of pathogens especially in time-sensitive cases?

The Micro-Dx™ diagnostic test allows to detect and identify, directly from clinical specimens (sterile body fluids, tissues or swabs), a broad spectrum of microorganisms, in just 7 hours.

If Micro-Dx™ displays a high positivity rate with concordant results with positive culture, its highest clinical added-value is in culture negative samples for which it identifies true sources of microbial infections.

With an overall positivity of 35% (culture overall positivity being 21%), Micro-Dx™ allows identifying 18% of additional infectious pathogens in culture-negative samples*. Higher rates were reported for specific conditions and difficult-to-culture specimens, such as heart valves in the context of infective endocarditis, as illustrated below.

*: results from a meta-analysis pooling 4,419 samples from 23 publications.

Such higher positivity is reported to be linked to the capacity of the test to accurately identify a broad-spectrum of clinically relevant pathogens, including some commonly met pathogens that may be inhibited in culture by prior antibiotic treatment as well as fastidious or non-growing pathogens.

Direct identification of infectious agents by Micro-Dx™ was also shown to assist physicians in targeting most appropriate antimicrobial therapy.

Learn more about Micro-Dx™ Clinical Performance:

Watch: How-To Take Advantage of Molzym’s Molecular Diagnostic Test?

 

Data highlighting the clinical added-value of Micro-Dx™ in specific conditions, such as sepsis, bone and joint infections, infective endocarditis, bacterial meningitis and pyomyositis, from various published clinical studies, are presented in Molzym’s White Paper:

Download White Paper:

Clinical Applications of Molzym’s Broad Spectrum Molecular Diagnostics

 

Get in touch with VH Bio to discuss using MMDx™ or with any questions about the Molzym product line.

 

 

 

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