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About CLSI



Feature-Rich Method Evaluation Software

StatisPro guides you through protocols to establish and verify test method performance characteristics.

The protocols faithfully follow CLSI standards, so you can be confident your analyses meet regulatory and accreditation requirements.

The Features

Streamlined Implementation:

Quickly and easily perform statistical analyses for analytical and diagnostic accuracy, comparability, precision, linearity, limits of detection and quantitation, and reference intervals.

Intuitive Organization:

Enter design parameters, type in data or copy and paste data from another application (including Microsoft® Excel®), follow the simple steps to complete the analysis, and then sign off on the study.


Automatically update charts and statistics as you enter data, make changes, or exclude obvious outliers. Hold the pointing device over charts to identify data points, or click data points in the charts to see corresponding observations in the dataset.

Professional Reports:

Clear, easy-to-understand reports with high-quality charts and tables ready to print, sign off on and file, or export as an Adobe® Acrobat® PDF to send to colleagues.

Study Advisor:

The Study Advisor provides clear, easy-to-understand instructions to guide you step-by-step through CLSI protocols, so even new personnel can perform method evaluation studies.

User’s Guide and Online Help:

Provide clear instructions on how to use the application, which complement the Study Advisor.

See how StatisPro helps users verify POCT devices [article]

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What’s New in Version 3.0?

  • Deming regression, Passing-Bablok regression, Bias plots are now included (EP09-A3).
  • Improvements to study design that match new guidelines and limit of detection and limit of quantitation estimation from the precision profile approach (EP17-A2).
  • Study templates let you easily create new studies based on similar previous studies.
  • Compare up to 10 instruments in the same study. You can also compare reagent lots (EP31).


Download the StatisPro Brochure

Learn all the ways that StatisPro helps you confidently meet quality and regulatory compliance demands.

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