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Kissler HJ et al. – Standard counting procedures for enumerating isolated stained human islets is a valid methodology, but computer–assisted digital image analysis assessment of islet mass has the added benefit of providing a permanent record of the isolated islet product being evaluated that improves quality assurance operations of current good manufacturing practice.


Exclusive Author Commentary
Dixon Kaufman, 09/11/09

This multi-center study involved all 8 member institutions of the National Institutes of Health-supported Islet Cell Resources consortium (Northwestern University, City of Hope, University of Miami, University of Minnesota, University of Pennsylvania, University of Illinois, University of Wisconsin, and University of Alabama). This collaborative multi-center study demonstrated the accuracy, repeatability and intermediate precision of the standard counting procedure for dithizone-stained human islets. This study also demonstrated that software-assisted digital image analysis as a supplemental method for islet quantification was as or more accurate and consistent than the standard manual counting method, with the added benefit of providing a permanent record of the isolated islet product being evaluated that improves quality assurance operations of current good manufacturing practice.

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