Siemens Healthineers, Tarrytown, NY, has received FDA premarket notification (510(k)) clearance for its blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care (POC) tests to aid in the diagnosis of renal diseases and metabolic imbalances. The assays expand precision medicine performed at the patient bedside to enable faster clinical decisionmaking.

Siemens Healthineers now can provide a full blood analysis menu on a single test card, enabling clinicians to perform all of the tests at the patient bedside using the company’s handheld Epoc blood analysis system. Such a broad menu benefits clinical service lines that routinely perform blood analysis, including cardiac catheterization labs, critical care units, emergency departments, outpatient centers, and radiology departments.

“These new assays will expand the patient information clinicians can access sooner to help rule-in or rule-out potential diagnoses more quickly,” says Michael Sampson, senior vice president of point-of-care diagnostics for North America at Siemens Healthineers. “Rapid, informed diagnoses and treatment decisions at the patient side ultimately aids in improving clinical outcomes.”

Combined with creatinine and an estimated glomular filtration rate (eGFR)—both also available on the Epoc system—BUN testing can aid in the differential diagnosis of renal and metabolic diseases. With other parameters that comprise a basic metabolic panel currently available at the point of care from Siemens Healthineers, TCO2 testing can aid clinicians in assessing acid base and metabolic imbalances, and making changes in therapy where necessary.

The Epoc blood analysis system delivers a full menu of results, including chloride, creatinine, glucose, hematocrit, ionized calcium, lactate, partial pressure of carbon dioxide, partial pressure of oxygen, pH, potassium, sodium—and soon BUN and TCO2. Results are provided in less than 1 minute, and are easily integrated into any laboratory information system.

For more information, visit Siemens Healthineers.