Validation protocol for multiple blood gas analyzers in accordance with laboratory accreditation programs

Ebner, P.A.R.; Romano, Paschoalina; Sant’anna, Alexandre; Mendes, Maria Elizabete; Oliveira, Magna; Sumita, Nairo Massakazu

doi:10.5935/1676-2444.20150048

Cited by 2 publications

(3 citation statements)

References 3 publications

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“…These results compare very well with similar studies conducted much later in other countries [16,17]. The good comparison between the results in this project and those conducted in other countries confirms the application of good laboratory practise at the hospital.…”

Section: Discussionsupporting

confidence: 90%

“…POCT offers improved turnaround time for test results and therapeutic action. The immediate availability of results might not translate to optimum patient management if the POCT instrument is not fully verified because instrument and method evaluation, is the available scientific and objective way to deem a method/analyser as fit for purpose [16].…”

Section: Discussionmentioning

confidence: 99%

“…POCT and arterial blood gas verification exercises similar to this exercise were conducted at Pondicherry Institute of Medical Sciences in India [15], Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo in Brazil [16] and Clermont-Ferrand University Teaching Hospital in France [17].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Point of Care Blood Gas Analyser Verification at the Largest Academic Hospital in Southern Hemisphere Revived by Coronavirus Calls for Tests to Be Verified

Buthelezi¹,

Rampota²,

Mphogo³

et al. 2020

PLM

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Introduction: At no point in the history of medicine has the importance of point-of-care testing (POCT) devices, tests and methods verification and utilisation been recognised and accepted than during the coronavirus pandemic. Blood gas analysers offer the best form of POCT and this has been demonstrated in the management of coronavirus patients admitted to hospital intensive care units with respiratory challenges. The new analysers were evaluated in compliance with the Clinical Laboratory Improvement Amendments (CLIA) regulation. The new method must be evaluated by comparison to the central laboratory or the outgoing analyser. The study was undertaken to verify if the new instrument, OMNI S b221 matches the wellestablished analysers currently in use at the hospital. Objectives: To evaluate method performance of pH, the partial pressure of carbon dioxide (pCO 2 ), the partial pressure of oxygen (pO 2 ), glucose, lactate, and electrolytes on OMNI S b221 blood gas analyser. Materials and Methods: To analyse the method performance of the pH, pO 2 , pCO 2 , glucose, lactate and electrolytes (Na + , K + Ca ++ ) on OMNI S b221 blood gas analyser 40 samples run on OMNI S b221 blood gas analyser were compared with the results obtained from ABL700, GEM PREMIER for all the parameters and the Roche Hitachi 917 analyser to compare two electrolytes (Na + and K + ). The correlation coefficient was calculated for the results obtained from each paired set of instruments (ABL 700 vs GEM PREMIER and ABL 700 vs OMNI S b221). Comparability between analyser methods performance was determined using linear regression analysis. Results: The correlation coefficient between the paired analytical platforms were all between 0.81 and 0.99, demonstrating a strong linear relationship. The coefficient of variation for all the parameters were less than 2 also demonstrating good precision. Conclusion: OMNI S b221 blood gas analyser correlated well with the outgoing ABL 700, GEM PREMIER blood gas analyser and the central laboratory analyser, Roche Hitachi 917 and therefore, verified as a good platform to run arterial blood gas samples.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%