Tools, Technologies and Training for Healthcare Laboratories

Interpretation of Differences in Serial Troponin Results

Despite years of intensive use and the recent advent of “high sensitivity” assays, fundamental questions about cardiac Troponin methods remain. Is precision of 10% CV required at the upper 99th percentile value of the reference population? Are methods with CV > 20% unacceptable? Is a change of 20% in an individual significant? Callum G Fraser, the internationally respected expert on biological variation, provides a logical technique for the interpretation of serial test results.

Upgrading Quality Control in Molecular Diagnostics

Are molecular diagnostics immune from quality problems? Do they need Quality Control? In this new field of testing, methods and manufacturers have been asserting their "difference" from traditional testing practices, while moving slowly on developing any new and different quality practices. Guest author Dr. Clark Rundell explains that "Traditional" QC protocols can be adopted to address gaps in quality assurance for molecular testing. [Reprint from IVD Technology magazine]

Stability Testing and CLSI EP25-A

A new CLSI guideline has come out with recommendations on the best way to calculate and interpret the stability of IVD reagents. We are pleased to present an essay by James Pierson-Perry, the chairholder of the CLSI subcommittee that developed the guideline, that introduces the concepts and the new recommendations.

Biologic Variation Database, the 2010 update

Dr. Carmen Ricos and colleagues explain the 2010 additions and updates to the biological variation database.

 

Rilibak: Quality Goals the German way

Jim Pierson-Perry and Oswald Sonntag discuss the German RiliBÄK rules. These new guidelines set new specifications for quality, both for performance of laboratories in EQA as well as routine operations. New concepts like the %Root Mean Square Deviation are introduced and explained.