Field test and validation of the DYNEX Technologies Inc. Multiplier® measles, mumps, rubella and varicella zoster multiplexed assay system in the Democratic Republic of the Congo using dried blood spots

Here we describe baseline validation studies and field performance of a research-use-only chemiluminescent multiplex serology panel for measles, mumps, rubella, and varicella-zoster virus used with dried blood spots in support of the 2013-2014 Democratic Republic of the Congo Demographic and Health Survey. Characterization of the panel using US-FDA-cleared commercial kits shows good concordance for measles, mumps, rubella and varicella zoster with average sensitivity across assays of 94.9% and an average specificity of 91.4%. As expected, performance versus available standards validated for plaque-reduction assays does not provide a 1:1 correspondence with International Units, yet demonstrates excellent linearity (average Hill’s Slope = 1.02) and ~4 logs of dynamic range. In addition, for the four specific assays, the multiplexed format allowed for inclusion of three positive and two negative controls for each sample. A prototype DYNEX Multiplier® chemiluminescent automated immunoassay ...