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About CLSI



Bring New Benefits to Your Staff and Your Laboratory

The StatisPro™ 3.0 feature-rich software enables your laboratory staff to easily and efficiently perform method validation and verification while ensuring conformance to accreditation and regulatory requirements.

You’ll realize the benefits that greater accuracy, efficiency, and compliance can bring to the quality of your testing and patient care. The protocols faithfully follow CLSI standards, so you can be confident your analyses meet regulatory and accreditation requirements.

The Benefits

With StatisPro, you can:

  • Avoid errors and complexity when implementing the latest statistics found in the CLSI standards.
  • Quickly and easily produce accurate statistical analyses of your test methods.
  • Meet increasing demands for more complex laboratory testing.
  • Save time with quick, easy-to-use software that guides you through each protocol.
  • Establish or verify performance characteristics of test methods.
  • Verify comparability of new methods and systems.
  • Ensure comparable results across measuring systems.
  • Verify or establish reference intervals or transfer an existing reference interval to a different, comparable method.
  • Verify or establish precision.
  • Verify or establish linearity (measuring interval or analytical measurement range).
  • Verify or establish the limits of detection and quantitation.
  • Properly prepare for inspection and accreditation.

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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).


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