Quality Control is one of the key issues at IVD-kits manufacturing. To assure the lot-to-lot consistency is critical to have consistent results when the reagents are used in the analyzers. To decide where to place the quality Control points is one of the more critical decisions, with large repercussion in the kits manufacturing costs. A single control point at the end of the process implies that a ‘no-pass’ result would force the whole batch to discard, wasting all the time and resources invested on it. Having too many QC along the different process steps would greatly increase the costs, as tests usually involve intensive labor and/or expensive analysis techniques.
For CLIA IVD-kits manufacturing (or any products involving magnetic beads), we can take advantage of the biomagnetic separation process itself to check the magnetic beads behavior. As usually there are many separation steps (several washing before and after each conjugation), having them optically monitored provide inexpensive QC points along the whole process.
If you want to know everything about monitoring biomagnetic separation processes in real time, download our free guide about this topic:
The dynamics of the magnetic beads are very different when the beads are well re-suspended and when clumps are formed. Basically, if you have clumps, the magnetic separation is equivalent to having beads of larger diameter and the process is faster. Unfortunately, the usual SOP (Standard Operation Procedures) only checks visually if the separation is complete at the defined separation time. Even if the clumps accelerate the separation time,it would be impossible to detect by eye-sight at the final specified time, as both suspensions would be crystal clear.
Taking advantage of advanced biomagnetic separation
By recording the transmitted light across the vessel, we can monitor the transparency changes during the separation process, showing the described sigmoidal-like behavior. As shown in the figure (real case), using the same suspension in the same SEPMAG® Q1L, the time is reduced by almost a 30% when beads have become aggregated due to a bad storage protocol.