Product development is a time-consuming, expensive process for CLIA-IVD kit manufacturers. There are several steps involved:
- Selecting the biomarker
- Choosing the right coupling
- Selecting the right magnetic bead
You are well versed with the first two points but what is “the right bead”? Assuming you have the right biomarker and a perfect coupling, the ideal magnetic bead should have the following properties:
- High recovery/fast separation, compatible with the timing of the analyzer step. It needs to be fast enough during large-scale production processes without high bead and coupled biomarker losses.
- No aggregation problems. Beads should be easy to re-suspend. It makes no sense to separate quickly if several additional sonication steps are required, which are difficult processes to control/implement in large volumes.
- Low kit-to-kit variability. Batch aliquots (typically less than a milliliter) of production batches (liters scale) must be consistent. If not, variability causes problems when interpreting the results in the analyzer.