Industry News: Beckman Coulter Offers its Largest Portfolio of Single Color CE-IVD and ASRs in Flow Cytometry

30 Jul 2018

Beckman Coulter Life Sciences has created its largest portfolio of single color CE-IVD and ASR (analyte-specific reagent) conjugated antibodies. With the recent launch of two Kappa and two Lambda polyclonal antibodies, the company has introduced more than 30 additional CE-IVD reagents and 10 new ASRs in the last year. The entire portfolio of single color antibodies for flow cytometry is manufactured under Good Manufacturing Practices (GMP).

The portfolio has featured at the 70th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Laboratory Expo (CLE), held July 2018 in Chicago, USA. Beckman Coulter Life Sciences, part of the Danaher Corporation, is exhibiting on booth #3612 alongside Beckman Coulter Diagnostics (another Danaher company).

Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit, said: “High standard, single color 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.”

Dr Koksch referred to a recent study published in Nature ii which 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 analyzing abnormal populations.

He added: “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.”

Beckman Coulter has more than 30 years’ experience in conjugated antibody development and manufacturing which has seen them command a market leading position. The company also builds efficiency into its antibody labeling with the product specificity on the top of the cap label to speed up product identification and workflow.

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