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Persistent Challenges of Interassay Variability in Transplant Viral Load Testing.

R T Hayden1, A M Caliendo2

  • 1Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA Randall.Hayden@stjude.org.

Journal of Clinical Microbiology
|June 20, 2020
PubMed
Summary

Standardizing viral load testing in transplant recipients is crucial for effective clinical management. Current challenges in viral quantification hinder accurate patient risk assessment and treatment decisions.

Keywords:
PCRcommutabilitydigital PCRquantitationstandardizationtransplant virusesviral load

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Area of Science:

  • Virology
  • Clinical Diagnostics
  • Transplant Medicine

Background:

  • Viral load quantification is standard care for infections in transplant recipients.
  • Significant challenges in standardization impede optimal clinical management.

Purpose of the Study:

  • To review the wide-ranging problems affecting viral load testing standardization.
  • To highlight issues impacting the clinical utility of viral load assays.

Main Methods:

  • Review of existing literature and clinical practices.
  • Analysis of challenges including assay standardization, international standards, and commutability.

Main Results:

  • Lack of FDA-approved/cleared tests and limited uptake of international standards.
  • Difficulties in accurate secondary standard quantification and assay commutability.
  • Inability to define predictive thresholds for disease risk and significant serial viral load changes.

Conclusions:

  • Standardization issues limit the full impact of viral load testing in clinical decisions.
  • Addressing these challenges requires collaboration between commercial entities, regulatory bodies, and professional societies.
  • Advancing the field necessitates solving problems related to assay characteristics and international guideline utility.