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Control Parameters
StatLIA automatically compares more than 50 parameters from the current assay to a pool of historical reference assays, including: |
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Standard raw and normalized responses |
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Min/Max detectable concentrations |
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Min/Max acceptable concentrations |
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Precision probabilities of each standard, control and unknown sample |
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% Concentration error of each standard, control and unknown sample |
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Fit probability and residual variance of standard and unknown curves |
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Residual error of each dilution on standard and unknown curves |
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Control sample raw and normalized responses and concentrations |
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Baseline standards (NSB / zero standard, max binding, total count) |
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| Some additional parameters that are reported include: |
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%CV |
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Backfit |
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R2 (goodness of fit) |
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ED20, ED50, ED80 |
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Regulatory Compliance |
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Documentation for assay validation and quality control is computed, recorded, printed and archived automatically |
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Statistical validation of analytical methods includes accuracy, precision, specificity, and range |
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Validation Package includes verification of mathematical computations by comparing StatLIA’s output to the corresponding output from Mathematica, a general purpose symbolic and numerical mathematical computational program |
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User-Defined control specimen ranges monitored automatically |
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Accuracy controls and % difference of their target concentrations are monitored |
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Quality Assurance reports |
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Levey-Jennings charts for control specimens and standards |
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Last 7 control samples flagged if all are above or below the mean |