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Guided Protocol for Fecal Microbial Characterization by 16S rRNA-Amplicon Sequencing

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Published on: March 19, 2018

Challenges for pathologists in implementing clinical microbiome diagnostic testing.

Yulia Gerasimova¹, Haroon Ali², Urooba Nadeem³

¹Department of Infectious Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA.

The Journal of Pathology. Clinical Research

|September 17, 2024

Summary

This summary is machine-generated.

Clinical microbiome testing shows promise for chronic diseases but faces implementation hurdles. This review outlines challenges in sample handling, methodology, interpretation, and regulation for clinical pathology labs.

Keywords:

microbiome microbiome testing pathologist pathologist and microbiome

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Area of Science:

Microbiology
Clinical Pathology
Disease Pathogenesis

Background:

The human microbiome is increasingly implicated in chronic diseases, including cancer.
Growing interest exists in clinical microbiome testing among healthcare professionals and the public.
Despite advances in microbial assay technologies, clinical adoption remains limited.

Purpose of the Study:

To provide an overview of the challenges hindering the implementation of microbiome testing in clinical pathology.
To discuss potential solutions to facilitate the integration of microbiome testing into routine clinical practice.

Main Methods:

Review of current challenges in clinical microbiome testing.
Discussion of preanalytical and analytical factors affecting sample handling and results.
Analysis of issues related to test methodology selection, reference range establishment, data interpretation, and clinical utility.
Consideration of regulatory and cost factors.

Main Results:

Significant challenges exist in preanalytical and analytical sample handling, impacting test reliability.
Selection of appropriate testing methodologies for specific clinical contexts is complex.
Establishing robust reference ranges and interpreting complex microbiome data for patient care decisions are major obstacles.
Regulatory approval and cost-effectiveness are critical barriers to widespread clinical adoption.

Conclusions:

Addressing challenges in sample handling, standardization, data interpretation, and regulation is crucial for clinical microbiome testing.
Potential solutions are proposed to expedite the integration of microbiome testing into clinical pathology laboratories.
Successful implementation could enhance diagnostic capabilities and patient care for microbiome-associated diseases.