Journal of virological methods 2017 11 07252() 15-23 pii 10.1016/j.jviromet.2017.11.001
Quantification of Cytomegalovirus (CMV) DNA is required for the initiation and monitoring of anti-viral treatment and the detection of viral resistance. However, due to the lack of standardisation of CMV DNA nucleic acid tests, it is difficult to set universal thresholds. In 2010, the 1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques was released. Since then CMV DNA viral load assays have been calibrated using this standard. Three external quality assessment (EQA) providers sent the same five samples to their participants and analysed the results to determine the equivalence of reporting CMV DNA results in international units per millilitre (IU/mL), and compared the difference in results reported in IU/mL with those reported in copies per millilitre (c/mL), and to determine the rate of adoption of IU/mL. About 78% of participants continue to report results in c/mL even though six of the 12 commercial assays are calibrated against the standard. The range of the results reported in IU/mL was less than those reported in c/mL indicating that the adoption of the WHO standard successfully improved the reporting of the CMV viral load. The variation in individual sample results reported by different assays, irrespective of whether in IU/mL or c/mL, is still great and therefore more standardisation of the assays is needed to allow the setting of treatment and monitoring thresholds. This study can act as a bench mark to determine rate of future adoption if reporting CMV DNA viral load results in IU/mL.