Single colour CE-IVD and ASRs in flow cytometry
A large portfolio of single colour CE-IVD and ASR (analyte-specific reagent) conjugated antibodies is now available from Beckman Coulter Life Sciences. With the launch of two Kappa and two Lambda polyclonal antibodies in 2018, the company has introduced more than 30 additional CE-IVD reagents and 10 new ASRs in the last couple of years. The entire portfolio of single colour antibodies for flow cytometry is manufactured under Good Manufacturing Practices (GMP). High standard, single colour reagents are at the heart of robust and consistent lab-developed tests (LDTs). Even so, establishing robust, accurate and reproducible assays can be a challenge. Several studies show the inadequacy of non-clinical-grade reagents because of inferior performance and problems around reproducibility. A recent study published in Nature showed that monoclonal antibodies were among the most commonly used tools in life sciences but also the greatest source of false findings. Poor quality conjugated antibodies, their specifications and performance can significantly distort data interpretation, in particular when analysing abnormal populations. To be able to routinely run Lab Developed Tests (LDTs), a high-end lab needs skilled staff with significant expertise in data interpretation. However, even with the right staff and robust procedures, poor reagent quality often leads to failed quality controls, challenges in interpreting data - and can even lead to false results. The list of potential pitfalls associated with poor antibodies is long and can have a negative impact on a study’s outcome. This is because of lack of reproducibility across lots, poor conjugation quality, low binding affinity, and non-specific staining.