Concepedia

Sample size and rejection limits for detecting reagent lot variability: analysis of the applicability of the Clinical and Laboratory Standards Institute (CLSI) EP26-A protocol to real-world clinical chemistry data

Sollip Kim, Jeonghyun Chang, Soo‐Kyung Kim, Sholhui Park, Jungwon Huh, Tae‐Dong Jeong

Clinical Chemistry and Laboratory Medicine (CCLM) · 2020 · 13 citations · 14 references

DOI

Abstract

The CLSI EP26-A did not provide all necessary answers. Alternative practical approaches are suggested when CLSI EP26-A does not provide guidance.

References

14

Current databases on biological variation: pros, cons and progress

V. Alvarez C. Ricós · Scandinavian Journal of Clinical and Laboratory Investigation · 1999 · 978 citations

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Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine

Sverre Sandberg, Callum G. Fraser, Andrea R. Horvath et al. · Clinical Chemistry and Laboratory Medicine (CCLM) · 2015 · 513 citations · Full text

Failure of Current Laboratory Protocols to Detect Lot-to-Lot Reagent Differences: Findings and Possible Solutions

Alicia Algeciras‐Schimnich, David E. Bruns, James C. Boyd et al. · Clinical Chemistry · 2013 · 102 citations · Full text

Performance criteria for combined uncertainty budget in the implementation of metrological traceability

Federica Braga, Ilenia Infusino, Mauro Panteghini · Clinical Chemistry and Laboratory Medicine (CCLM) · 2015 · 76 citations · Full text

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Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain

Cas Weykamp, Sandra Secchiero, Mario Plebani et al. · Clinical Chemistry and Laboratory Medicine (CCLM) · 2016 · 41 citations · Full text