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Intercenter Variability in the Application of Biopsy-based Transcriptomics in Kidney Transplantation.

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Biopsy-based transcriptomics (BBT) shows moderate agreement with histology in kidney transplants, with varied center indications. Standardizing BBT use is crucial for integrating molecular diagnostics into routine care.

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Area of Science:

  • Nephrology
  • Transplant Immunology
  • Molecular Diagnostics

Background:

  • Biopsy-based transcriptomics (BBT) was introduced in Central Europe in 2022 to enhance kidney transplant diagnostics.
  • Significant variations in diagnostic practices among transplant centers using BBT require further investigation.

Purpose of the Study:

  • To evaluate differences in BBT indications across transplant centers.
  • To assess discrepancies between traditional histology and BBT (MMDx) results in kidney graft biopsies.
  • To analyze the impact of center volume on diagnostic concordance.

Main Methods:

  • Retrospective analysis of 474 kidney graft biopsies from 10 centers (August 2022 - May 2024).
  • Simultaneous application of routine histology and BBT using the Molecular Microscope Diagnostic System (MMDx).
  • Evaluation of Banff 2022 histology criteria against MMDx findings and assessment of center-specific BBT utilization patterns.

Main Results:

  • BBT was utilized in only 12%-31% of biopsies, with histology dominating diagnostic decisions.
  • Significant variability in BBT indications, including cases with histological no-rejection, chronic AMR, and borderline changes.
  • Moderate agreement between BBT and histology (κ = 0.49), with molecular AMR detected in 10-77% of specific histological categories and molecular TCMR in 9-26% of cases.
  • Discrepancy rates were similar between high- and low-volume centers.

Conclusions:

  • A moderate level of discrepancy exists between histology and MMDx results, irrespective of transplant center volume.
  • The indications for employing BBT in kidney transplant diagnostics are highly variable across centers.
  • Standardized indications for BBT are necessary to effectively integrate molecular diagnostics into routine clinical practice.