Comparison of Analytical Performance of i-Smart 300 and pHOx Ultra for the Accurate Determination of Pleural Fluid pH

Abstract

Background: Pleural fluid pH is an essential test for diagnosing complicated parapneumonic effusion. We evaluated the performance of two blood gas analyzers in measuring pleural fluid pH.

Methods: The i-STAT G3+ (Abbott) was used as a reference analyzer to evaluate the pH values obtained from other methods: the i-Smart 300 (i-SENS), the pHOx Ultra (Nova Biomedical), using a clot catcher to filter off microclot, and pH indicator paper. Within-device precision was performed using quality control materials. We compared pleural fluid pH (n = 86) by the above methods and analyzed the concordance rate at the level of the medical decision point, pH 7.2.

Results: The within-device coefficient of variations of pH were below 0.1% for all blood gas analyzers tested. The slopes of the regression equations for the i-Smart 300, pHOx Ultra, and pH indicator paper against the reference analyzer were 0.850 (95% confidence interval, CI, 0.800-0.896), 0.714 (95% CI, 0.671-0.766), and 1.105 (95% CI, 0.781-1.581), respectively. The kappa values for the i-Smart 300, pHOx Ultra, and pH indicator paper against the reference analyzer were 0.883 (95% CI, 0.656-1.110), 0.739 (95% CI, 0.393-1.084), and 0.464 (95% CI, 0.102-0.826), respectively.

Conclusions: The i-Smart 300 and pHOx Ultra demonstrated good analytical performance and diagnostic accuracy when determining pleural fluid pH compared with that by the i-STAT G3+, whereas the pH indicator paper showed unsatisfactory results.