“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,” says Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “However, in the current healthcare setting, nonhospitalized 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 offsite 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 recently cleared device, St. Pierre adds, “processing time may now be reduced by making testing available in these additional settings.”

XW-100自动血液学分析仪来自Sysmex American Inc,Ill,Ill,Ill,旨在用于2岁及以上的患者,他需要全血细胞计数和白细胞差异。测试结果可用于其他临床和实验室调查结果,为需要额外测试的患者提供早期警报,这些患者对这种严重贫血和农血吸虫病进行这种严重的条件。然而,分析仪并非旨在诊断或监测患有初级或二次血液病变的患者,包括肿瘤学和危重病患者。


“XW-100是一种突破,将改变患者和治疗它们的医疗保健专业人员的血液检测,”Sysmex America的首席执行官Ralph Taylor说。“除了制定更快的治疗计划之外,该技术将提高医疗保健递送的效率。”



“The XW-100 is the culmination of our long journey to develop a high-quality hematology analyzer able to deliver accurate and reliable results in a CLIA-waived primary care setting,” says Andy Hay, chief operating officer of Sysmex America. “During that time, Sysmex made considerable investments in comprehensive testing and market acceptance studies, as well as in building a robust infrastructure and related systems to ensure the XW-100 safely serves healthcare professionals and the patients who depend on them.”

Sysmex expects to begin shipping the XW-100 in early 2018.