Analyse-it Software, a provider of statistical analysis software, has announced a major new release of the Analyse-it Method Evaluation edition
Aimed at in vitro diagnostic companies and clinical laboratories, Analyse-it helps meet Clia/Cap and similar regulations for method validation.
Statistics and charts are provided to validate, verify and demonstrate analytical method accuracy, precision, linearity, and reference intervals in accordance with the latest CLSI evaluation protocols and other industry recognised protocols.
Laboratories can establish or verify method performance when introducing a new method, or demonstrate performance is back on track after a proficiency test failure.
IVD companies can evaluate diagnostic performance of a new method during the early stages of development, right through to putting together the final analytical performance claims for regulatory compliance.
Widely cited in peer-reviewed published research since 1997, Analyse-it includes many specialist clinical laboratory statistics.
Speaking at the launch, Simon Huntington, director of Analyse-it Software, said: "The Analyse-it Method Evaluation edition allows our customers to satisfy seven of the latest CLSI evaluation protocols, many of which previously could only be calculated by tedious, error-prone, hand calculation".
