November 6, 2017

FDA Clears Common Blood Cell Count Test That Offers Faster Results for Patients, Providers

ROCKVILLE, Md -- November 6, 2017 -- The US Food and Drug Administration (FDA) has cleared a complete blood cell count (CBC) test that, based on its categorisation, can be run in more healthcare settings, including physicians’ offices, clinics or other types of healthcare facilities, by a wider range of personnel (ie, support staff). This broadened test access will allow for faster availability of results.

“A CBC is one of the most common physician-ordered tests used to evaluate a patient’s blood levels, determine if an infection is present and if immediate intervention is needed,” said Donald St. Pierre, FDA’s Center for Devices and Radiological Health, Rockville, Maryland. “However, in the current healthcare setting, non-hospitalised patients who require a CBC can experience at least a 24-hour wait for test results, if not longer, when the test is performed by an off-site laboratory. This waiting period may be detrimental to the health of patients whose care depends on quick results to rule out conditions that may require immediate medical intervention. With the device cleared today, processing time may now be reduced by making testing available in these additional settings.”

The XW-100 Automated Hematology Analyzer is intended for use in patients aged 2 years and older who require a whole blood cell count and white blood cell differential. Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions such as severe anaemia and agranulocytosis, who require additional testing. However, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients.

The device works by using a blood sample to classify and quantify 12 different haematology parameters, which provides patients with a blood component profile as part of their overall health assessment.

The FDA reviewed data from a study conducted on 582 samples collected from patients aged 2 to 92 years. The study compared the XW-100 test results collected by non-medical personnel in CLIA-waived settings to a haematology analyser in an accredited clinical laboratory. Results found that by following the manufacturer’s instructions for use, accurate testing can be effectively conducted by untrained personnel.

SOURCE: US Food and Drug Administration

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