Video 4: Laboratory considerations for adopting a new assay
While the quantification of viruses that cause important infections in transplant recipients has been the standard of care for years, important challenges related to standardisation 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 video focuses on a broad array of problems, including the lack of available FDA-approved or cleared tests, limited uptake of international standards, accurate quantification of secondary standards, specific assay characteristics, and commutability.
These factors, taken together, 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 standardised assay.