Validation of methodologies for quantifying isolated human islets: an Islet Cell Resources study.
Validation of methodologies for quantifying isolated human islets: an Islet Cell Resources study.
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DOI：
10.1111/j.1399-0012.2009.01052.x
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发表时间：
2010-03
影响因子：
2.1
通讯作者：
Kaufman DB
中科院分区：
文献类型：
--
作者：
Kissler HJ;Niland JC;Olack B;Ricordi C;Hering BJ;Naji A;Kandeel F;Oberholzer J;Fernandez L;Contreras J;Stiller T;Sowinski J;Kaufman DB
胰岛质量的量化是定义胰岛产品质量的关键标准，确保在用于特定 I 型糖尿病患者的治疗干预时进行有效的胰岛移植。这项多中心研究涉及美国国立卫生研究院支持的胰岛细胞资源 (ICR) 联盟的所有 8 个成员机构。该研究旨在通过确定准确性、重复性（观察者内部变异性）和中间精度（观察者间变异性）来验证用于量化分离的、双硫腙染色的人类胰岛的标准计数程序作为可靠的方法。该研究的第二个目的是评估一种新的软件辅助数字图像分析方法作为胰岛定量的补充。该研究证明了人类离体胰岛标准计数程序的准确性、重复性和中间精度。这项研究还表明，软件辅助数字图像分析作为胰岛定量的补充方法比标准手动计数方法更准确和一致。用于计数分离的染色人类胰岛的标准计数程序是一种有效的方法，但计算机辅助的胰岛质量数字图像分析评估具有提供所评估的分离的胰岛产品的永久记录的额外好处，从而改善了当前良好生产规范（cGMP）的质量保证操作。
Quantification of islet mass is a crucial criterion for defining the quality of the islet product ensuring a potent islet transplant when used as a therapeutic intervention for select patients with type I diabetes. This multi-center study involved all 8 member institutions of the National Institutes of Health-supported Islet Cell Resources (ICR) consortium. The study was designed to validate the standard counting procedure for quantifying isolated, dithizone-stained human islets as a reliable methodology by ascertaining the accuracy, repeatability (intra-observer variability), and intermediate precision (inter-observer variability). The secondary aim of the study was to evaluate a new software-assisted digital image analysis method as a supplement for islet quantification. The study demonstrated the accuracy, repeatability and intermediate precision of the standard counting procedure for isolated human islets. This study also demonstrated that software-assisted digital image analysis as a supplemental method for islet quantification was more accurate and consistent than the standard manual counting method. 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 (cGMP).
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影响因子：
3
作者：
Wexler, EJ;Peters, EE;Kerr, JS
通讯作者：
Kerr, JS
影响因子：
2.6
作者：
Fiedor, PS;Oluwole, SF;Hardy, MA
通讯作者：
Hardy, MA
DOI：
10.1007/bf02581331
发表时间：
1990-07-01
期刊：
ACTA DIABETOLOGICA LATINA
影响因子：
--
作者：
RICORDI, C;GRAY, DWR;LACY, PE
通讯作者：
LACY, PE
影响因子：
2
作者：
Went, P.;Mayer, S.;Dirnhofer, S.
通讯作者：
Dirnhofer, S.
影响因子：
3.3
作者：
Lembert, N;Wesche, J;Ammon, HPT
通讯作者：
Ammon, HPT