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The Diagnostic Assay Development Landscape and
Researching New Opportunities
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acceptable error limits assay error assay results bias calculated calibration cause cause-and-effect diagram Chapter Clin Chem clinician conjoint analysis consultant cumulative data analysis decision analysis decision-analysis design of experiments detection diagnostic assay digoxin distribution Equation error model error sources estimation of total evaluation example experiments failure mode failure rate fault trees financial modeling fishbone glucose goals graph imprecision improved incorrect influence diagram input instrument system knowledge Krouwer laboratory launch date Lifescan linear drift manufacturer medically acceptable error metric mg/dL multifactor protocols NCCLS occur outlier rate parameter Pareto analysis patient sample performance claim performance specifications predictions probability problems product development profitability provides Quality Function Deployment quality-control limits reliability growth management schedule service call simulation slope software bugs solution statistical statistician Table techniques tion Tolerance Interval total analytical error typical variables Yes Stylish