Overview

To reduce variables and gain confidence in the results, assay controls are a critical bedrock of good science.

This is even more important in complex and multi parameter cell analysis assays that utilize flow cytometry, NGS and other methods to interrogate cells. The most valuable assay controls go beyond simply providing positive and negative readouts, and can both mimic the testing process and report out the assay accuracy and sensitivity.

Procedural controls help to ensure that the assay is run properly and all aspects are performed as expected. Most importantly, the procedural controls must be a material that can go through the same established procedures as the testing sample. Typical procedural controls, such as beads, cells or analyte, cannot be fully used in the process, yield inconsistent results or are post-process spike-ins. Similarly, multi-level controls such as LLOQ/LLODs (lower limit of quantification/detection) are informative for ensuring the sensitivity of the assay. The fundamental challenge has been that these controls either do not exist in biological specimens or do not work simultaneously as procedural controls.

The next generation of assay controls need to be multifaceted enough to serve as accurate sensitivity controls while being robust enough to function simultaneously as process controls. With the breakthrough cellular mimics developed at Slingshot, we offer the first-of-its-kind solution to this fundamental challenge in assay controls.