Hematology Analyzer Granted Waiver Offers Faster Results

An automated hematology analyzer has been granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The CLIA waiver for this device allows it to be used by a variety of non-traditional laboratory sites, including physicians’ offices, clinics or other types of health care facilities.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) today cleared a complete blood cell count (CBC) test that, based on its categorization, 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. This broadened test access will allow for faster availability of results.

The FDA reviewed data from a study conducted on 582 samples collected from patients ranging from two to 92 years old. The study compared the XW-100 automated hematology analyzer (Sysmex America Inc, Mundelein, IL, USA) test results collected by non-medical personnel in CLIA-waived settings to a hematology analyzer 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.

The XW-100 is intended for use in patients two years of age 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 anemia (low red blood cell or hemoglobin count) and agranulocytosis (low white blood cell count), who require additional testing. The device works by using a blood sample to classify and quantify 12 different hematology parameters, which provides patients with a blood component profile as part of their overall health assessment. Once prepared for each day's use, the XW-100 will allow health care professionals to provide patients with blood test results in as few as three minutes.

Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, said, “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. However, in the current health care setting, non-hospitalized 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.”