Assay Validation Test Sheet - PowerPoint PPT Presentation
Title:
Assay Validation Test Sheet
Description:
Like most assays used in a clinical setting, validation of flow cytometry assays before use for diagnostic or clinical research purposes is a critical step. Assay validation is conducted to confirm that the method is fit for its intended use and the assay meets specific criteria with respect to stability requirements, accuracy and robustness, to name a few. In this downloadable PDF, we provide specific tests that are useful in validation and representative flow cytometry data for an important validation test script. For more details visit us: – PowerPoint PPT presentation
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Title: Assay Validation Test Sheet
1
FlowMetrics Available Valida4on Tests
- All Valida4on plans are created
?t--for--purpose for each client - Valida4on plans evaluate assay reliability and
overall performance and may include but are not
limited to - Example of Inter--sample variability of
Regulatory T cells in Cynomolgus macaque
- Precision of the assay
- Inter--assay Precision
- Accuracy
- Curve Suitability
- Repeatability (Intra--assay Precision)
- Robustness of the assay
- Limits of Detec4on
- Dynamic Range/Limits of Quan4?ca4on
- Dilu4onal Linearity
Singlets Live Cells Lymphocytes CD3CD4 Cells
Cyno 1
Cyno 2
Cyno 3
- Sample stability
- Processed Stability
- Freeze/Thaw Stability
- Long--Term Stability
ltAPCgt CD25
ltAPCgt CD25
ltAPCgt CD25
- Assay speci?city
- Inter--sample variability
Number in dot plot represents percentage 1
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