Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital
| العنوان: | Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital |
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| المؤلفون: | Bouvier, Damien, Duret, Thomas, Rouzaire, Paul, Jabaudon, Matthieu, Rouzaire, Marion, Nourrisson, Céline, Bourgne, Céline, Pereira, Bruno, Evrard, Bertrand, Sapin, Vincent |
| المساهمون: | CHU Clermont-Ferrand, Laboratoire de Biochimie, Génétique, Reproduction et Développement (GReD), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire Microorganismes : Génome et Environnement (LMGE), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Centre National de la Recherche Scientifique (CNRS)-Université d'Auvergne - Clermont-Ferrand I (UdA), Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-Université d'Auvergne - Clermont-Ferrand I (UdA)-Centre National de la Recherche Scientifique (CNRS) |
| المصدر: | Practical Laboratory Medicine Practical Laboratory Medicine, Vol 10, Iss C, Pp 21-33 (2018) Practical Laboratory Medicine, Elsevier, 2018, 10, pp.21-33. ⟨10.1016/j.plabm.2017.12.001⟩ Practical Laboratory Medicine, 2018, 10, pp.21-33. ⟨10.1016/j.plabm.2017.12.001⟩ |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 030213 general clinical medicine, Method validation, Point-of-care testing, Clinical Biochemistry, Analytical chemistry, 030204 cardiovascular system & hematology, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Article, Central laboratory, Blood gas, lcsh:Chemistry, 03 medical and health sciences, 0302 clinical medicine, NF ISO 15189, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], NF ISO 22870, Reproducibility, lcsh:R5-920, Radiological and Ultrasound Technology, Repeatability, 3. Good health, lcsh:QD1-999, Environmental science, University teaching, lcsh:Medicine (General) |
| الوصف: | Background Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, pCO2, pO2, Na+, K+, Cl-, Ca2+, lactate, hemoglobin and oxyhemoglobin (O2Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital. Methods Precision was studied at two control levels for each parameter. Comparisons between GEM analyzers were performed (on 30 samples) for pH, pCO2, pO2, Na+, K+, Cl-, Ca2+, lactate, hemoglobin and O2Hb; and between GEM analyzers and the central laboratory for Na+, K+, Cl-, Ca2+ and hemoglobin (on 30–50 samples). Uncertainty in measurement (UM) was evaluated with an approach using reproducibility and accuracy data. Results The coefficients of variation (CVs) were in line with recommendations, except for the repeatability CV for pO2. All CVs were below 4%. All comparisons complied with recommendations. Uncertainties of measurement were also validated. Conclusion Our results met standard requirements and the 12 analyzers were assessed as suitable for point-of-care testing in services of academic medical centers, as exemplified at Clermont-Ferrand hospital. Highlights • Complete method validation of 12 analyzers for POCT in a multisite hospital. • First published values of uncertainty in measurement very useful for pO2 and O2Hb. • Comparison between GEM4000 and central lab analyzers for Na+, Cl-, K+, lactate, Hb. |
| تدمد: | 2352-5517 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3cf97caf305ccdfbdd85c8e0082acb5Test https://pubmed.ncbi.nlm.nih.gov/29487890Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....c3cf97caf305ccdfbdd85c8e0082acb5 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23525517 |
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