The Clinical and Laboratory Standards Institute (CLSI) has released an updated version of its method evaluation software, StatisPro 3.0. StatisPro software guides users through protocols to establish and verify test method performance characteristics. The protocols follow CLSI standards, so users can be confident that their analyses meet regulatory and accreditation requirements.
This new version, StatisPro 3.0, includes an implementation of CLSI document EP09-A3—Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition. New topic areas from this document comprise Deming regression, Passing-Bablok regression, and bias plots. StatisPro 3.0 has also been updated to include implementation of CLSI document EP17-A2—Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. The information incorporated from this document includes improvements to study design that match new guidelines and limit of detection and limit of quantitation estimation from the precision profile approach.
According to CLSI representatives, StatisPro can be used to avoid errors and complexity when implementing the latest statistics found in the CLSI standards and quickly and easily produce accurate statistical analyses of test methods. It can produce reports on analytical accuracy, precision, linearity, limits of detection and quantitation, and reference intervals based on CLSI standards. It can be used to evaluate performance parameters when introducing a new method or reagents or when replacing laboratory instrumentation. Learn more about products and services offered by CLSI.
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