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About CLSI



Accurate and Compliant Method Evaluation

The StatisPro™ 3.0 feature-rich software enables your laboratory to perform method evaluation protocols that faithfully follow CLSI standards.

With StatisPro, you’ll know that you’re ensuring quality while conforming to regulatory compliance demands.

Standards Included

You can produce reports on analytical and diagnostic accuracy, comparability, precision, linearity, limits of detection and quantitation, and reference intervals based on the most up-to-date versions of the following nine CLSI documents—all of which are recognized by the College of American Pathologists (CAP), The Joint Commission, and the US Food and Drug Administration (FDA):

  • Evaluation of Precision (EP05)
  • Evaluation of the Linearity (EP06)
  • Method Comparison and Bias Estimation (EP09)
  • Preliminary Evaluation of Linearity, Drift, Carryover, and Precision (EP10)
  • Evaluation of Qualitative Test Performance (EP12)
  • Verification of Precision, Method Comparison, and Trueness (EP15)
  • Evaluation of Limits of Detection and Quantitation (EP17)
  • Defining, Establishing, and Verifying Reference Intervals (EP28)
  • Multi-instrument Method Comparison (EP31)

Technical Specifications

  • Runs on Microsoft® Windows XP®, Windows Vista®, Windows 7®, Windows 8®, Windows Server® 2003 or 2008
  • Requires 2.5 GHz or faster processor; 1 GB or more RAM; 40 MB or more free disk space
  • Print requires any Microsoft® Windows® compatible printer
  • E-mail option requires Microsoft® Outlook® 2000 or later
  • Annual subscription fee includes support and any upgrades during the subscription period

purchase statispr

StatisPro is an excellent method evaluation tool. It is easy to use, yet it is packed with powerful features like outlier detection and flexibility in setting up studies. It has many sources of help available to new users, and it follows the CLSI guidelines. In the past year, we have evaluated more than 50 new or modified laboratory methods, and I cannot imagine completing the necessary validation and verification reports if it wasn’t for StatisPro.

– Jack Maggiore, Assistant Director, Chemistry Laboratory and R&D Doctor’s Data, Inc., St. Charles, Illinois, USA


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