Clinical and Laboratory Standards Institute (CLSI) unveiled the release of StatisPro™, its new method evaluation software package for the evaluation, verification, and validation of performance characteristics of laboratory test methods at the AACC/ASCLS Annual Meeting this week.

StatisPro software delivers a feature-rich tool designed to perform the statistical analysis necessary to meet regulatory and accreditation requirements. Hospitals, physician office laboratories, reference laboratories, and customer support departments of in vitro diagnostic manufacturers can benefit from using this new method evaluation software.

David Grenache, PhD, DABCC, FACB, Associate Professor, Department of Pathology, University of Utah, ARUP Laboratories, and beta-tester for StatisPro, says, "The benefits of StatisPro are its ease-of-use and intuitive interface. When validating a new method, replacing equipment, or preparing for accreditation or regulatory inspections, StatisPro makes advanced statistical analysis easier regardless of the size of the laboratory using it."

Developed in conjunction with Analyse-it®, StatisPro can produce reports on analytical accuracy, precision, linearity, limit of detection and quantitation, and reference intervals and is entirely based on the most up-to-date CLSI guidelines.
With StatisPro, laboratories can:

  • Verify comparability of new methods and systems.
  • Ensure comparable results across measuring systems.
  • Establish reference intervals or transfer intervals between methods and laboratories.

James Huntington, Co-founder, Analyse-it®, describes the importance of evaluating and verifying method performance, saying,
"Laboratories must ensure method performance is as expected to meet regulatory or accreditation requirements. As the statistics necessary to determine method performance become more complex, software such as StatisPro is essential to ensure accurate, correct, determination of method performance."

CLSI partnered with Analyse-it because of its excellent reputation and proven experience in creating statistically based software, as well as its similar culture and values to CLSI, explains Glen Fine, MS, MBA, CAE, CLSI Executive Vice President. "Since StatisPro is based on CLSI’s world-renowned best practices, it will inspire user confidence. This is the only software package available that streamlines implementation of CLSI’s latest method evaluation guidelines. StatisPro allows staff of laboratories of any size to produce advanced statistical calculations and display reports quickly and accurately in order to ensure the highest quality patient care," says Fine.

Source: CLSI