دورية أكاديمية

Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data

التفاصيل البيبلوغرافية
العنوان: Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data
المؤلفون: Matar, G., Poggi, B., Meley, R., Bon, C., Chardon, L., Chikh, K., Renard, A.-C., Sotta, C., Eynard, J.-C., Cartier, R., Cohen, R.
المساهمون: 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-École Supérieure de Chimie Physique Électronique de Lyon (CPE)-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 - CNRS Chimie (INC-CNRS)-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 - CNRS Chimie (INC-CNRS)-Centre National de la Recherche Scientifique (CNRS), University Hospital and University Jean Monnet, Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E), Matériaux, ingénierie et science Villeurbanne (MATEIS), 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)-Centre National de la Recherche Scientifique (CNRS)
المصدر: Clinical Chemistry and Laboratory Medicine ; https://hal.science/hal-01804725Test ; Clinical Chemistry and Laboratory Medicine, 2015, 53 (11), pp.1725-1736. ⟨10.1515/cclm-2014-0942⟩
بيانات النشر: HAL CCSD
سنة النشر: 2015
المجموعة: HAL Lyon 1 (University Claude Bernard Lyon 1)
مصطلحات موضوعية: biochemistry, blood clotting time, gamma glutamyl transferase blood level, human, iron blood level, lactate dehydrogenase blood level, linear regression analysis, major clinical study, partial thromboplastin time, phosphate blood level, potassium blood level, priority journal, prothrombin time, sodium blood level, triacylglycerol blood level, triacylglycerol lipase blood level, urea blood level, evaluation study, health care quality, procedures, statistical model, Hemostasis, Humans, Immunoassay, Linear Models, Quality Assurance, Health Care, Quality Control, Uncertainty, alanine aminotransferase
الوصف: cited By 12 ; International audience ; Background: 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. Methods: 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. Results: 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. Conclusions: 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.
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: hal-01804725; https://hal.science/hal-01804725Test
DOI: 10.1515/cclm-2014-0942
الإتاحة: https://doi.org/10.1515/cclm-2014-0942Test
https://hal.science/hal-01804725Test
رقم الانضمام: edsbas.3227030F
قاعدة البيانات: BASE