FDA已清除完整的血细胞计数(CBC)分析仪,可用于各种医疗机构,包括医生办公室和诊所,并由各种人员管理,包括支持人员。根据该机构的说法,扩大的测试访问可能允许更快的结果可用性。

“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。

该器件通过使用血液样本来分类和量化12种不同的血液特征,为血液成分概况提供患者,作为其整体健康评估的一部分。该装置使用15μl样品的静脉血液,提供具有三部分白细胞差异的CBC,提供12种临床有用的结果,所有这些结果都可以在短至3分钟内获得。

“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。”

XW-100自动血液学分析仪被授予1988年(CLIA)的临床实验室改善修正案下的免除复杂性分类。通过双重提交途径进行审查分析仪,通过申请进行预览通知(510(k))清除和CLIA豁免的流线型监管途径。系统最初于2015年通过510(k)途径清除,以便在患者的护理点使用。

FDA从2至92岁的患者中收集的582个样本进行的研究中审查了研究的数据。该研究将CLIA免除环境中的非医疗人员收集到认可的临床实验室中的血液学分析仪中的非医疗人员收集的XW-100测试结果。研究结果表明,通过遵循制造商的使用说明,可以通过未经培训的人员有效地进行准确的测试。

“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.