FDA Draft Guidance on Multiplexed Microbiological Devices Raises Many Questions

Let's talk multiplex assay controls, writes Avraham Harris in the IVD Technology group on LinkedIn. Specifically, he has a few questions about FDA draft guidance on highly multiplexed microbiological devices.

For example, what is the purpose of the non-target DNA contained within the negative specimen control, he asks. "Specifically, what kind of nonspecific detection is it capable of controlling and why would this nonspecific detection suddenly become apparent if it was not there previously?" Also, Harris wonders why this control must undergo specimen processing and whether every run should contain this control or if it can be run periodically, like a no template control.

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