Clinical and Laboratory Standards Institute (CLSI) has released its new method evaluation software package, StatisPro, for the evaluation, verification, and validation of performance characteristics of laboratory test methods at the AACC/ASCLS Annual Meeting.
CLSI said that the hospitals, physician office laboratories, reference laboratories, and customer support departments of in-vitro diagnostic (IVD) manufacturers can benefit from using the StatisPro software.
StatisPro software delivers a feature-rich tool designed to perform the statistical analysis necessary to meet regulatory and accreditation requirements.
CLSI said that the StatisPro, developed in conjunction with Analyse-it, 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 and establish reference intervals or transfer intervals between methods and laboratories.
James Huntington, co-founder of Analyse-it, said: “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.”
Glen Fine, executive vice president of CLSI, said: “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.”
David Grenache, associate professor, department of pathology at University of Utah, Arup Laboratories, and beta-tester for StatisPro, said: “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.”