Whole blood Coagulation analyzers (WBCAs) are widely used point-of-care (POC) testing devices found primarily in cardiothoracic surgical suites and cardia catheterization laboratories. Most of these devices can perform a number of coagulation tests that provide information about a patient's blood clotting status. Clinicians use the results of the WBCA tests, which are available minutes after applying a blood sample, primarily to monitor the effectiveness of heparin therapy--an anticoagulation therapy used during cardiopulmonary bypass (CPB) surgery, angioplasty, hemodialysis, and other clinical procedures. In this study we evaluated five WBCAs from four suppliers. Our testing focused on the applications for which WBCAs are primarily used: Monitoring moderate to high heparin levels, as would be required, for example, during CPB are angioplasty. For this function, WCBAs are typically used to perform an activated clotting time (ACT) test or, as one supplier refers to its test, a heparin management test (HMT). All models included in this study offered an ACT test or an HMT. Monitoring low heparin levels, as would be required, for example,during hemodialysis. For this function, WBCAs would normally be used to perform either a low-range ACT (LACT) test or a whole blood activated partial thromboplastin time (WBAPTT) test. Most of the evaluated units could perform at least one of these tests; one unit did not offer either test and was therefore not rated for this application. We rated and ranked each evaluated model separately for each of these two applications. In addition, we provided a combined rating and ranking that considers the units' appropriateness for performing both application. We based our conclusions on a unit's performance and humans factor design, as determined by our testing, and on its five-year life-cycle cost, as determined by our net present value (NPV) analysis. While we rated all evaluated units acceptable for each appropriate category, we did identify some significant differences that enabled us to rank the units in order of preference. We have included a Selection, Purchasing, and use guide at the end of this study to help facilities identify the unit that will best meet their needs.
全血凝血分析仪(WBCAs)是广泛使用的即时检测(POC)设备,主要应用于心胸外科手术室和心脏导管插入实验室。这些设备大多能进行多项凝血检测,提供患者血液凝固状态的信息。临床医生使用全血凝血分析仪检测的结果(在采集血样后几分钟即可获得),主要用于监测肝素治疗的效果——肝素是一种在体外循环(CPB)手术、血管成形术、血液透析及其他临床操作中使用的抗凝治疗药物。在本研究中,我们评估了来自四个供应商的五台全血凝血分析仪。我们的测试集中在全血凝血分析仪的主要应用方面:监测中度至高度肝素水平,例如在体外循环或血管成形术期间所需的水平。对于此功能,全血凝血分析仪通常用于进行活化凝血时间(ACT)测试,或者如一个供应商所称的其测试——肝素管理测试(HMT)。本研究中纳入的所有型号都提供ACT测试或HMT。监测低肝素水平,例如在血液透析期间所需的水平。对于此功能,全血凝血分析仪通常用于进行低范围ACT(LACT)测试或全血活化部分凝血活酶时间(WBAPTT)测试。大多数被评估的设备至少能进行其中一项测试;有一台设备这两项测试都无法进行,因此未对该应用进行评级。我们针对这两种应用分别对每个评估型号进行了评分和排名。此外,我们还给出了一个综合评分和排名,考虑了各设备对两种应用的适用性。我们的结论基于测试所确定的设备性能和人为因素设计,以及通过净现值(NPV)分析所确定的其五年生命周期成本。虽然我们将所有评估设备在每个适用类别中都评为可接受,但我们确实发现了一些显著差异,使我们能够按偏好顺序对这些设备进行排名。我们在本研究末尾附上了一份选择、购买和使用指南,以帮助各机构确定最能满足其需求的设备。