The following information has been communicated to roche customers: roche has confirmed performance issues with certain lots of the elecsys anti-ccp assay on the cobas e 411 analyzer; modular analytics e 170 module; and cobas e 601, 602, and 801 modules with plasma samples.The following customer observations have been reported: 1.Discrepant results between serum and plasma samples from the same blood draw of a given patient: negative results (< cutoff) on serum and positive results on plasma samples.2.Discrepant concentrations obtained on plasma samples when comparing different reagent lots.Serum samples are not affected and do not require a workaround.It is strongly advised to use the elecsys anti-ccp assay with serum samples only for the affected lots.Roche is conducting an investigation into the reported issue and has determined that the elecsys anti-ccp assay is strongly affected by pre-analytical errors.The investigation has reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples.Therefore, we would like to emphasize the importance of following the pre-analytical sample handling recommendations when processing samples (serum and plasma).
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