A common blood cell count (CBC) test helps physicians assess patients’ blood levels and determine if there is an infection and whether immediate intervention is required. Often, non-hospitalized patients who require a CBC can experience at least a 24-hour wait for test results. Point-of-care analyzers can help to reduce this waiting period. Sysmex, the hematology diagnostic leader in the U.S., Asia and Europe recently announced that the U.S. Food and Drug Administration (FDA) has approved its point-of-care XW-100 automated hematology analyzer. The first fully automated hematology analyzer to receive approval as a CLIA-waived product, this unit is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential. The CLIA waiver for this analyzer allows it to be used by a variety of non-traditional laboratory sites, including physicians’ offices, clinics or other types of healthcare facilities with a CLIA Certificate of Waiver.
Once prepared for each day’s use, the XW-100 will allow healthcare professionals to provide patients with blood test results in as few as three minutes. It uses a blood sample to classify and quantify 12 different blood characteristics to provide patients with a blood component profile as part of their overall health assessment.
Based on its categorization, this unit can be run in more healthcare settings, including physicians’ offices, clinics or other types of healthcare facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.
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.
Easy-to-operate, this instrument can analyze a sample and provide results in about the same time it takes to send a test for outside analysis. It comes with a simple interface and an array of features, such as a physician alert if additional testing is required.
According to Andy Hay, chief operating officer of Sysmex America, “The XW-100 is the culmination of a long journey to develop a high-quality hematology analyzer able to deliver accurate and reliable results in a CLIA-waived primary care setting.”