Jackson Shane L, Bereznicki Luke R, Peterson Gregory M, Marsden Katherine A, Jupe David M L, Vial Janet H, Rasiah Rohan L, Misan Gary, Williams Sharon M
School of Pharmacy, University of Tasmania, Hobart, Tasmania.
Aust J Rural Health. 2004 Aug;12(4):137-42. doi: 10.1111/j.1440-1854.2004.00585.x.
To compare the accuracy and clinical usefulness of the near-patient testing CoaguChek S INR monitor in rural medical practice. DESIGN, SETTING AND MAIN OUTCOME MEASURES: General practices were identified through Australian university departments of rural health. Study investigators trained general practitioners and/or practice nurses in the use of the CoaguChek S INR monitor. General practices obtained a fingerprick sample for testing with the INR monitor to compare with conventional pathology testing for accuracy. An evaluation questionnaire was administered to users of the machine to assess ease of use and clinical usefulness.
A total of 169 patients from 15 general practice sites provided 401 paired (CoaguChek S and laboratory) INR results. The CoaguChek S was found to be accurate when compared to laboratory INR (r = 0.89), despite complicating variables such as multiple users of the monitor and multiple laboratories used for comparison with the CoaguChek S INR. Overall, 88% of dual INR measurements were within 0.5 INR units of each other. For laboratory INR </= 1.9, 2.0-3.5 and >/= 3.6, 97%, 90% and 57% of readings were within 0.5 INR units, respectively. Clinical agreement occurred 93% and 90% of the time against published expanded and narrow criteria, respectively.
The routine use of near-patient testing, with appropriate training and quality assurance programs, has the potential to increase the safety and efficacy of warfarin therapy in rural and remote communities.
比较即时检测的CoaguChek S国际标准化比值（INR）监测仪在农村医疗实践中的准确性和临床实用性。
设计、设置和主要测量指标：通过澳大利亚大学农村卫生系确定普通诊所。研究人员对普通科医生和/或执业护士进行CoaguChek S INR监测仪使用培训。普通诊所采集手指血样用INR监测仪检测，以与传统病理检测比较准确性。对该仪器使用者进行评估问卷调查，以评估其易用性和临床实用性。
来自15个普通诊所的169例患者提供了401对（CoaguChek S检测结果与实验室检测结果）INR结果。尽管存在监测仪多个使用者以及与CoaguChek S INR比较时使用多个实验室等复杂变量，但与实验室INR相比，CoaguChek S被发现是准确的（r = 0.89）。总体而言，88%的双份INR测量值彼此相差在0.5 INR单位以内。对于实验室INR≤1.9、2.0 - 3.5和≥3.6，分别有97%、90%和57%的读数相差在0.5 INR单位以内。与已公布的扩大和严格标准相比，临床一致性分别在93%和90%的时间出现。
通过适当培训和质量保证计划进行即时检测的常规使用，有可能提高农村和偏远社区华法林治疗的安全性和有效性。
