VERIS Molecular Diagnostic System Sample-To-Sample Crossover Contamination Study

Sample carry-over and cross-contamination present a high risk for diagnostic medical devices. VERIS was developed to have a false positive rate due to cross contamination of less than 1 in 500 tests with an overall design goal of zero. The objective of this study was to assess the sample-to-sample contamination rate using a real-time PCR assay, characterize potential sources of contamination, and develop system modifications that lead to effectual resolution of carry-over and cross-contamination artifacts.