Viral Load Testing in Transplant Medicine Hampered by Poor Assay Standardisation
Despite viral load quantification being standard of care for transplant recipients, persistent interassay variability prevents defining reliable disease-risk thresholds and clinically significant change values. Contributing factors include limited FDA-cleared tests, poor uptake of international standards, and commutability problems with secondary calibrators. The authors call on commercial companies, regulators, and professional societies to collaboratively solve these standardisation problems.
The original study
Persistent Challenges of Interassay Variability in Transplant Viral Load Testing.
- Authors
- Hayden RT, Caliendo AM
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 32554479
Original abstract
While quantification of viruses that cause important infections in transplant recipients has been the standard of care for years, important challenges related to standardization remain. The issues are wide ranging, and until they are adequately addressed, the full impact of viral load testing regarding clinical management decisions will not be realized. This review focuses on a broad array of problems, including the lack of available FDA-approved/cleared tests, limited uptake of international standards, accurate quantification of secondary standards, specific assay characteristics, and commutability. Though some of these topics are nuanced, taken together they greatly influence the clinical utility of testing. For example, it has not been possible to define thresholds that predict the risk of developing disease and determine significant changes in serial viral load values for a given patient. Moreover, the utility of international guidelines may be limited due to the lack of a standardized assay. By summarizing the issues, the hope is that commercial companies, regulatory agencies, and professional societies can come together to advance the field and solve these problems.