FDA Clears Siemens Pleural Fluid pH Test for RAPIDPoint 500 System

Siemens Healthcare Diagnostics has obtained FDA clearance to offer pleural fluid pH testing on its RAPIDPoint® 500 Blood Gas System, providing U.S. laboratories and point-of-care coordinators with an important new diagnostic tool for critical care situations. The pH measurement of pleural fluids can be a clinically useful tool in the management of patients with parapneumonic effusions, which may be a symptom of underlying illness.

When a patient’s pleural fluid pH is less than 7.30 (normal pleural fluid pH is estimated at 7.64), it may suggest the presence of an inflammatory or infiltrative process. While these measurements can be taken using pH meters or indicator sticks, multiple studies have shown these methods to be less accurate than readings conducted with blood gas analyzers. Moreover, the American College of Chest Physicians (ACCP) recommends blood gas analyzers as the preferred pleural fluid chemistry test for categorizing and managing parapneumonic effusions.

The addition of pleural fluid pH testing on the company’s RAPIDPoint 500 system complements the analyzer’s comprehensive critical care menu, which includes tests for blood gases, electrolytes, glucose, lactate and full CO-oximetry, including neonatal total bilirubin and total hemoglobin. The RAPIDPoint 500 system leverages Siemens proven technology to deliver laboratory-quality results in approximately 60 seconds from a single, whole blood sample. Further, the analyzer’s measurement cartridges last up to 28 days and contain a full complement of tests, reducing downtime.