Abstract
Background: 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. Methods: This multi-center study involved all eight member institutions of the National Institutes of Health-supported Islet Cell Resources 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. Results: 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. Conclusions: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 236-242 |
| Number of pages | 7 |
| Journal | Clinical Transplantation |
| Volume | 24 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 1 2010 |
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Keywords
- Image analysis
- Islets of Langerhans
- Quality control
ASJC Scopus subject areas
- Transplantation
Cite this
Validation of methodologies for quantifying isolated human islets : An islet cell resources study. / Kissler, H. J.; Niland, J. C.; Olack, B.; Ricordi, Camillo; Hering, B. J.; Naji, A.; Kandeel, F.; Oberholzer, J.; Fernandez, L.; Contreras, J.; Stiller, T.; Sowinski, J.; Kaufman, D. B.
In: Clinical Transplantation, Vol. 24, No. 2, 01.03.2010, p. 236-242.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Validation of methodologies for quantifying isolated human islets
T2 - An islet cell resources study
AU - Kissler, H. J.
AU - Niland, J. C.
AU - Olack, B.
AU - Ricordi, Camillo
AU - Hering, B. J.
AU - Naji, A.
AU - Kandeel, F.
AU - Oberholzer, J.
AU - Fernandez, L.
AU - Contreras, J.
AU - Stiller, T.
AU - Sowinski, J.
AU - Kaufman, D. B.
PY - 2010/3/1
Y1 - 2010/3/1
N2 - Background: 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. Methods: This multi-center study involved all eight member institutions of the National Institutes of Health-supported Islet Cell Resources 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. Results: 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. Conclusions: 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.
AB - Background: 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. Methods: This multi-center study involved all eight member institutions of the National Institutes of Health-supported Islet Cell Resources 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. Results: 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. Conclusions: 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.
KW - Image analysis
KW - Islets of Langerhans
KW - Quality control
UR - http://www.scopus.com/inward/record.url?scp=77952910549&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77952910549&partnerID=8YFLogxK
U2 - 10.1111/j.1399-0012.2009.01052.x
DO - 10.1111/j.1399-0012.2009.01052.x
M3 - Article
VL - 24
SP - 236
EP - 242
JO - Clinical Transplantation
JF - Clinical Transplantation
SN - 0902-0063
IS - 2
ER -