Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital

Charlotte Oris , Yoan Clavel , Matthieu Jabaudon (1) , Annick Pialat , Hadj Abdelkader Mohamed , Frédérique Lioret , Vincent Sapin (2) , Damien Bouvier (1)

1 CHU Clermont-Ferrand
2 Laboratoire de Biochimie

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, pCO 2 , pO 2 , Na + , K + , Cl-, Ca 2+ , lactate, hemoglobin and oxyhemoglobin (O 2 Hb) 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, pCO 2 , pO 2 , Na + , K + , Cl-, Ca 2+ , lactate, hemoglobin and O 2 Hb; and between GEM analyzers and the central laboratory for Na + , K + , Cl-, Ca 2+ 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 pO 2. 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.

Domaines: Pneumologie et système respiratoire; Physiologie [q-bio.TO]

Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, Annick Pialat, Hadj Abdelkader Mohamed, et al.. Method validation of a set of 12 GEM® Premier™ 4000 blood gas analyzers for point-of-care testing in a university teaching hospital. Practical Laboratory Medicine, 2018, 10, pp.21 - 33. ⟨10.1016/j.plabm.2017.12.001⟩. ⟨hal-01919218⟩