6 November 2017 - The U.S. FDA today cleared a complete blood cell count test that, based on its categorisation, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.

“A complete blood count 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. However, in the current health care setting, non-hospitalised patients who require a complete blood count can experience at least a 24-hour wait for test results, if not longer, when the test is performed by an off-site laboratory,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “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.”

Read FDA press release