Measurements for 8 Common Analytes in Native Sera Identify Inadequate Standardization among 6 Routine Laboratory Assays
| Autor: | Hedwig C M, Stepman, Ulla, Tiikkainen, Dietmar, Stöckl, Hubert W, Vesper, Selvin H, Edwards, Harri, Laitinen, Jonna, Pelanti, Linda M, Thienpont, Marzena, Modzelewska |
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| Rok vydání: | 2014 |
| Předmět: |
Blood Glucose
Analyte Pathology medicine.medical_specialty Standardization Clinical Biochemistry Sensitivity and Specificity Article Total error Phosphates Biological variation External quality assessment Humans Medicine Triglycerides Ldl cholesterol Chromatography Clinical Laboratory Techniques business.industry Biochemistry (medical) Routine laboratory Serum samples Uric Acid Cholesterol Creatinine business |
| Zdroj: | Clinical Chemistry. 60:855-863 |
| ISSN: | 1530-8561 0009-9147 |
| Popis: | BACKGROUNDExternal quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results.METHODSWe used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample–matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation.RESULTSMost assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (−4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%.CONCLUSIONSThe design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects. |
| Databáze: | OpenAIRE |
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