During validation of a new automated assay, why is carryover testing included?

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Carryover is about residual material from a previous sample that can remain in the instrument and appear in the next sample. In validating a new automated assay, showing that carryover is negligible is essential so that a high-concentration sample doesn’t falsely skew the result of the following sample. This is tested by running a high-titer sample followed by a low-titer or blank sample and checking whether the signal in the subsequent sample indicates any material carried over from the prior run. If carryover meets predefined limits, it confirms that the washing and fluidics steps are sufficient and that results will be accurate across many samples and runs. This protects patient results from cross-contamination. Choices that refer to instrument color, packaging, or power supply address unrelated aspects of instrument performance, not cross-sample contamination.