On November 6, 2017, the U.S. Food and Drug Administration (USFDA) has cleared a complete blood cell count (CBC) test (XW-100 Automated Hematology Analyzer) to Sysmex America, Inc. The XW-100 Automated Hematology Analyzer offers faster results for patients and providers based on its categorization, and 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 ).
The XW-100 Automated Hematology Analyzer is intended for use in patients ≥2 years of age 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 for 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. 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 blood characteristics (hematology 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 ranging from 2 to 92 years of age. The study compared the XW-100 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 Automated Hematology Analyzer was also 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 nontraditional laboratory sites, including physicians' offices, clinics or other types of health care facilities with a CLIA Certificate of Waiver (CLIA-waived settings).
The CLIA certificate to a laboratory depends upon the complexity of the tests it performs. CLIA regulations describe three levels of test complexity: waived tests, moderate complexity tests and high complexity tests.
The XW-100 Automated Hematology Analyzer was originally cleared through the 510(k) pathway in 2015 for use at the patient's point-of-care. To support the use of this device in CLIA-waived settings with non-medical personnel, the analyzer provides simple instructions for operator actions when results are flagged or outside of a specified range. To further ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters has been reduced to 1238.
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38 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htm
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