Analyse-it Method Evaluation Edition
Introduction
This edition is a method validation software for IVDs, Clinical Laboratories and Researchers to validate, verify, and demonstrate analytical and diagnostic method performance.
Supporting the latest CLSI and industry-recognised protocols, Analyse-it Method Evaluation lets you meet CLIA, CAP, JCAHO & ICH-Q2A/B analytical method validation requirements to validate, verify and demonstrate analytical accuracy, precision, linearity, recovery, reference intervals, and diagnostic performance.
- IVD companies can validate performance during development or when compiling final analytical performance claims for regulatory compliance.
- Researchers can verify methods meet the manufacturer's analytical and diagnostic performance claims.
- Laboratories can demonstrate performance of a new method to meet CLIA requirements, or demonstrate performance is back on track after a proficiency test failure.
Analyse-it is now used by Abbott Diagnostics, Astra-Zeneca, Beckman Coulter, the FDA, Glaxo-Smith-Kline, Johnson & Johnson, Pfizer, and Roche, to name just a few. Advantages of the software include:
- Easy-to-use data-entry templates for use by laboratory staff.
- Accurate & reliable, avoiding tedious, error-prone hand calculations.
- Print-ready reports, easily distributed to key laboratory staff by e-mail.
- Runs as an add-in to Microsoft Excel, so there's virtually no learning curve.
- A proven product, cited in hundreds of peer-reviewed papers over the last 10 years.
- Includes all the statistics from the Analyse-it Standard edition.
Statistics and charts you need
Analyse-it Method Evaluation edition provides all the procedures you need to establish and demonstrate method:
- Accuracy – visualise and compare the analytical accuracy of two methods, or verify accuracy is within goal or meets manufacturer's claim. Satisfies CLSI EP-9, EP-12, EP-15, EP-21, and includes Deming regression, Weighted Deming regression, Passing & Bablok and Bland-Altman bias plots.
- Precision – visualise and determine analytical precision over days, runs or concentrations, or verify precision is within goal or meets manufacturer's claim. Satisfies CLSI EP-5, EP-15.
- Linearity – visualise and examine linearity and reportable range, verify linearity is within goal or meets manufacturer's claim. Satisfies CLSI EP-6.
- Test performance – visualise and determine diagnostic performance, compare diagnostic performance of multiple methods, and analyse performance of specific decision levels. Satisfies CLSI EP-12, and includes ROC curve analysis and Delong ROC Curve comparisons.
- Reference intervals – visualise and establish reference intervals, or verify an existing interval. Satisfies CLSI-28 and IFCC-EPTRV.
A proven reliable report
Analyse-it has been available for over 10 years, is used by tens of thousands of customers world-wide, and is cited in hundreds of published peer-reviewed papers.
Analyse-it is validated against published datasets, many published in research by the authors of procedures, and also against other software. With independent validation performed by many of our customers before implementation, you can sure that Analyse-it is reliable and trustworthy.
Easy to use, with help along the way
Full help is included with Analyse-it, written in easy-to-understand plain English. Statistical jargon is avoided wherever possible. Step-by-step instructions guide you through using Analyse-it, and help you interpret the statistics and charts. The Getting Started tutorial mean you will be up-and-running with Analyse-it is less than 10minutes. Of course if you get stuck our widely-praised customer support are here to help. Most queries are answered quickly, with almost all answered within 24 hours.
Work within the familiar Excel environment
Why learn how to use a complex statistics package? Staying in the familiar Excel environment means there is virtually no learning curve! Analyse-it integrates into Excel ’97 to 2007 and analyses data directly from your worksheet. You don't have to export your data to another package, and won't end up with your data locked into an in-accessible, proprietary, file format. With your data in Excel you can easily exchange data with colleagues. Analyse-it's perfectly formatted reports means you can print the analysis results immediately, or copy-paste charts and statistics into your own documents or presentations. Chart look is based on the most popular formats used in published research, so charts are immediately ready for inclusion into research. Once analysed, your analysis can be saved as a standard Excel workbook, forwarded to colleagues, and even re-opened later and updated. Data can be added, corrected, included or excluded as outliers and the analysis updated to re-analyse the dataset.