Murray E T, Fitzmaurice D A, Allan T F, Hobbs F D
Department of General Practice, Medical School, University of Birmingham, UK.
J Clin Pathol. 1999 Nov;52(11):842-5. doi: 10.1136/jcp.52.11.842.
To compare the reliability and relative costs of three international normalised ratio (INR) near patient tests.
Protime (ITC Technidyne), Coaguchek (Boehringer Mannheim), and TAS (Diagnostic Testing).
All patients attending one inner city general practice anticoagulation clinic were asked to participate, with two samples provided by patients not taking warfarin. A 5 ml sample of venous whole blood was taken from each patient and a drop immediately added to the prepared Coaguchek test strip followed by the Protime cuvette. The remainder was added to a citrated bottle. A drop of citrated blood was then placed on the TAS test card and the remainder sent to the reference laboratory for analysis. Parallel INR estimation was performed on the different near patient tests at each weekly anticoagulation clinic from July to December 1997.
19 patients receiving long term warfarin treatment provided 62 INR results. INR results ranged from 0.8-8.2 overall and 1.0-5.7 based on the laboratory method. Taking the laboratory method as the gold standard, 12/62 results were < 2.0 and 2/62 were > 4.5. There were no statistical or clinically significant differences between results from the three systems, although all near patient tests showed slightly higher mean readings than the laboratory, and 19-24% of tests would have resulted in different management decisions based on the machine used in comparison with the laboratory INR value. The cost of the near patient test systems varied substantially.
All three near patient test systems are safe and efficient for producing acceptable and reproducible INR results within the therapeutic range in a primary care setting. All the systems were, however, subject to operator dependent variables at the time of blood letting. Adequate training in capillary blood sampling, specific use of the machines, and quality assurance procedures is therefore essential.
比较三种国际标准化比值（INR）即时检测的可靠性及相对成本。
凝血时间测定仪（ITC Technidyne公司）、罗氏卓越型血糖仪（Boehringer Mannheim公司）和TAS检测系统（Diagnostic Testing公司）。
邀请所有前往市中心一家普通科抗凝门诊就诊的患者参与，未服用华法林的患者提供两份样本。从每位患者采集5毫升静脉全血样本，立即将一滴血滴加到准备好的罗氏卓越型血糖仪测试条上，随后滴入凝血时间测定仪比色皿。其余血液加入到含有柠檬酸盐的瓶中。然后将一滴含有柠檬酸盐的血液滴在TAS检测卡上，其余血液送至参考实验室进行分析。1997年7月至12月期间，在每周的抗凝门诊对不同的即时检测进行平行INR测定。
19名接受长期华法林治疗的患者提供了62个INR结果。总体INR结果范围为0.8 - 8.2，基于实验室方法的范围为1.0 - 5.7。以实验室方法作为金标准，62个结果中有12个<2.0，2个>4.5。三种检测系统的结果之间无统计学或临床显著差异，尽管所有即时检测的平均读数均略高于实验室检测，并且与实验室INR值相比，19% - 24%的检测会因使用的仪器不同而导致不同的管理决策。即时检测系统的成本差异很大。
在基层医疗环境中，所有三种即时检测系统在治疗范围内产生可接受且可重复的INR结果方面都是安全且有效的。然而，在采血时，所有系统都受到操作人员相关变量的影响。因此，在毛细血管采血、仪器的具体使用和质量保证程序方面进行充分培训至关重要。
