1. Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data
- Author
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Karim Chikh, Catherine Sotta, Bernard Poggi, Anne-Claude Renard, Jean-Christophe Eynard, Régine Cartier, Chantal Bon, Gladys Matar, Laurence Chardon, Roland Meley, Richard B. Cohen, Métabolisme, Enzymes et Mécanismes Moléculaires (MEM²), Institut de Chimie et Biochimie Moléculaires et Supramoléculaires (ICBMS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut de Chimie du CNRS (INC)-École Supérieure Chimie Physique Électronique de Lyon-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut de Chimie du CNRS (INC)-École Supérieure Chimie Physique Électronique de Lyon-Centre National de la Recherche Scientifique (CNRS), University Hospital and University Jean Monnet, Matériaux, ingénierie et science [Villeurbanne] (MATEIS), and Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)
- Subjects
030213 general clinical medicine ,Percentile ,iron blood level ,chloride ,Quality Assurance, Health Care ,alpha fetoprotein ,Clinical Biochemistry ,030204 cardiovascular system & hematology ,phosphate blood level ,magnesium ,[SPI.MAT]Engineering Sciences [physics]/Materials ,0302 clinical medicine ,iron ,aspartate aminotransferase ,partial thromboplastin time ,follitropin blood level ,calcium blood level ,creatine kinase blood level ,glucose ,sodium ,bilirubin blood level ,Immunoassay ,medicine.diagnostic_test ,potassium ,creatinine ,Uncertainty ,General Medicine ,CA 15-3 antigen ,Biochemistry ,health care quality ,priority journal ,gamma glutamyltransferase ,Measurement uncertainty ,bilirubin ,triacylglycerol ,alpha fetoprotein blood level ,chloride blood level ,alkaline phosphatase ,follitropin ,bicarbonate blood level ,Quality Control ,Analyte ,amylase ,sodium blood level ,CA 125 antigen ,alanine aminotransferase ,bicarbonate ,urea ,prostate specific antigen ,Article ,alkaline phosphatase blood level ,03 medical and health sciences ,evaluation study ,urea blood level ,Linear regression ,External quality assessment ,Proficiency testing ,medicine ,triacylglycerol lipase blood level ,biochemistry ,Humans ,procedures ,human ,phosphate ,potassium blood level ,Hemostasis ,calcium ,business.industry ,lactate dehydrogenase blood level ,creatine kinase ,carcinoembryonic antigen ,Biochemistry (medical) ,statistical model ,cholesterol ,lactate dehydrogenase ,triacylglycerol blood level ,external quality assessment ,triacylglycerol lipase ,prothrombin time ,major clinical study ,blood clotting time ,Health Care ,CA 19-9 antigen ,linear regression analysis ,Linear Models ,urate ,business ,Quality Assurance ,gamma glutamyl transferase blood level ,aspartate aminotransferase blood level ,Quality assurance ,alanine aminotransferase blood level - Abstract
International organizations require from medical laboratories a quantitative statement of the uncertainty in measurement (UM) to help interpret patient results. The French accreditation body (COFRAC) recommends an approach (SH GTA 14 IQC/EQA method) using both internal quality control (IQC) and external quality assessment (EQA) data. The aim of this work was to validate an alternative way to quantify UM using only EQA results without any need for IQC data. This simple and practical method, which has already been described as the long-term evaluation of the UM (LTUM), is based on linear regression between data obtained by participants in EQA schemes and target values. We used it for 43 routine analytes covering biochemistry, immunoassay, and hemostasis fields.Data from 50 laboratories participating in ProBioQual (PBQ) EQA schemes over 25 months were used to obtain estimates of the median and 90th percentile LTUM and to compare them to the usual analytical goals. Then, the two UM estimation methods were compared using data from 20 laboratories participating in both IQC and EQA schemes.Median LTUMs ranged from 2.9% (sodium) to 16.3% (bicarbonates) for biochemistry analytes, from 12.6% (prothrombin time) to 18.4% (factor V) for hemostasis analytes when using the mean of all participants, and were around 10% for immunoassays when using the peer-group mean. Median LTUMs were, in most cases, slightly lower than those obtained with the SH GTA 14 method, whatever the concentration level.LTUM is a simple and convenient method that gives UM estimates that are reliable and comparable to those of recommended methods. Therefore, proficiency testing (PT) organizers are allowed to provide participants with an additional UM estimate using only EQA data and which could be updated at the end of each survey.
- Published
- 2014