Validate and verify your analytical and diagnostic methods to meet the demands of regulatory compliance.
Analyse-it is developed for and is in use at thousands of ISO/IEC 17025 accredited testing and calibration laboratories, ISO 15189 accredited medical laboratories, CLIA ’88 regulated medical laboratories, and IVD manufacturers for development, support, product labeling and FDA 510(k) submissions.
The latest Clinical and Laboratory Standards Institute (CLSI) method validation protocols are recognized by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA).
It’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. 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.
Rated best ROC curve software in Clinical Chemistry March 2003 vol. 49 no. 3 pg. 433-439, Analyse-it lets you establish and compare the ability of a diagnostic test to correctly diagnose patients. Explore how the test differentiates between positive and negative cases and explore optimum decision thresholds factoring in the costs of misdiagnosis.
When 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.
Reference intervals are essential for clinicians to interpret results and make a diagnosis. As a laboratory it’s your job to provide normal reference ranges they can rely on. With the widest range of methods available in any software package, the ability to partition the intervals by factors such as sex, age, ethnicity, Analyse-it makes it easy to establish reference ranges or transfer them to a new measurement procedure.
All the features from the Analyse-it Standard Edition are included so you can improve processes and products by identifying solutions using hypothesis tests and model fitting techniques.
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 to those 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.
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