The Clinical and Laboratory Standards Institute (CLSI) has announced the release of Statispro, a method evaluation software for clinical laboratories.
This software can be used to establish and verify the performance of laboratory test methods by performing the statistical analysis necessary to demonstrate compliance with regulatory and accreditation requirements.
It can be used in hospitals, physician office laboratories and reference laboratories, and by in-vitro diagnostic manufacturers.
The Statispro software can produce reports on analytical accuracy, precision, linearity, limit of detection and quantitation, and reference intervals based on the most up-to-date CLSI guidelines.
It can be used to evaluate performance parameters when introducing a new method or new reagents and when replacing laboratory instrumentation.
It can also be useful after a maintenance call or when quality control data indicate the need for further evaluation.
Developed in conjunction with Analyse-it, Statispro method evaluation software provides clear step-by-step advice on performing a study, and faithfully implements the latest CLSI method evaluation guidelines.
