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Flow cytometry is a well-established approach used in numerous clinical assays across the globe. But like most assays used in a clinical setting, flow cytometry assays typically need to be validated before they can be used for diagnostic or clinical research purposes.
Assay validation is done to demonstrate that a method is accurate, specific, reproducible and robust over a designated range of measurement. Flow cytometry is considered an analytical method, and according to the FDA, flow cytometry assays need to meet specific analytical method validation criteria. A validated assay can then be used in situations requiring GLP/GCP (good laboratory/clinical practice) compliance, like a clinical trial or routine diagnostic test.
Chelsea Riveley, an associate director at FlowMetric, Inc. explains the nuts and bolts of flow cytometry assay validation. “Validation is usually what follows assay development,” Riveley said. Validation is done to confirm that the method is fit for its intended use and the assay meets specific criteria with respect to stability requirements, accuracy, precision, specificity, detection limit, limit of quantitation, linearity and range, ruggedness, and robustness.Read the full article »
There comes a moment when the flow cytometry work can be too much. Sometimes it’s the big “make-or-break” experiment that has to go just right, or sometimes it’s the monthly batches of clinical trial samples that have to be handled, on a Saturday, with swift, deft hands, and you’re the only one qualified for the job. That’s when you either break down in tears of exhaustion and frustration, or you consider finding some help. Now most investigators aren’t in a position to hire and train new staff for cytometry work, but there is high quality and reliable alternative—A contract research organization (CRO).Read the full article »
Flow cytometry has been developed and used as a clinical tool since the invention of the first cytometers in the 1970s. At present, flow cytometry is considered essential for many routine clinical diagnostics, including assays for leukemia and lymphoma, stem cell enumeration, solid organ transplantation, HIV infection status, immunodeficiencies, and hematologic abnormalities. Many scientists involved in clinical trials or drug development are faced with developing clinical flow cytometry assays for multiple phases of clinical development.
If you find yourself starting to plan a clinical flow cytometry assay, here are the top 3 issues to think about as you plan your experiment.Read the full article »