Validate and verify measurement system performance characteristicsIt’s essential to ensure the performance characteristics (precision, trueness, linearity, interferences, detection capability) of a measurement procedure meet the requirements for intended use. Manufacturers (IVD companies) must establish performance during product development to feedback into the development process, for FDA 510k submissions and product marketing, and to support customers in the field.
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Laboratories must verify they can achieve the manufacturer's claimed performance during implementation of a new measurement system, during regulatory inspections (under the CLIA ’88 act), and as part of proficiency testing (PT) schemes. Measurement systems analysis (MSA) lets you determine all these important performance characteristics in one analysis. Compare methods and evaluate the impact of making changesWhen introducing a new measurement procedure you want to see how it stacks-up against your existing procedure or evaluate its performance against the gold-standard.
Bland-Altman lets you see the agreement between methods and what effect the differences between methods might have on clinical interpretation. More advanced procedures like Deming regression and Passing-Bablok tell you the bias between methods, how medical decision points may be affected, and let you test if bias meets performance requirements. Integrated into Microsoft Excel, so it's easy to use.That's right. Analyse-it integrates into Microsoft Excel 2007, 2010, 2013, 2016, 2019 and Office 365 for Microsoft Windows.There's virtually no learning curve, and the intuitive user interface and logical task-based workflow makes sense tothose of us that aren’t programmers or full-time statisticians.All your data and results are kept in Excel workbooks, making it easy to collaborate and share them with colleagues, and meaning there's no locked-in file format. Qualitative. Diagnostic performance for 1 test, 2 paired tests, or 2 independent tests/groups. Sensitivity/Specificity with Clopper-Pearson exact or Wilson score confidence interval.
Likelihood ratios with Miettinen-Nurminen score confidence interval. Predictive values with Mercado-Wald logit confidence interval. Odds ratio, and Youden's index. Mosaic plot of outcomes.
Difference between sensitivity/specificity with Newcombe or Tango score confidence intervals. McNemar-Mosteller exact, Fisher exact, and Score Z test for equality of sensitivity/specificity.Supports CLSI.
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