High‐sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events

Author:

Sommer Ulrike1,Eck Steven2,Marszalek Laura3,Stewart Jennifer J.4,Bradford Jolene5,McCloskey Thomas W.6,Green Cherie7,Vitaliti Alessandra1,Oldaker Teri8,Litwin Virginia9

Affiliation:

1. Novartis Institutes of Biomedical Research, Novartis Pharma AG Basel Switzerland

2. Integrated Bioanalysis Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca Gaithersburg USA

3. Northwestern Memorial Hospital Chicago Illinois USA

4. Flow Contract Site Laboratory Bothell Washington USA

5. Thermo Fisher Scientific Eugene Oregon USA

6. ICON Laboratory Services Farmingdale New York USA

7. A Member of Roche Group, Development Sciences Department Genentech, Inc. South San Francisco California USA

8. Oldaker Consulting San Clemente California USA

9. Caprion Biosciences Montreal Quebec Canada

Publisher

Wiley

Subject

Cell Biology,Histology,Pathology and Forensic Medicine

Reference34 articles.

1. Circulating Tumor Cell Analysis: Technical and Statistical Considerations for Application to the Clinic

2. Limit of blank, limit of detection and limit of quantitation;Armbruster D. A.;Clinical Biochemist Reviews,2008

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