Poller L, Keown M, Chauhan N, van den Besselaar A M H P, Tripodi A, Shiach C, Jespersen J
ECAA Central Facility, School of Biological Sciences, The University of Manchester, 3 239 Stopford Building, M13 9PT, Manchester, UK.
Thromb Res. 2002 Jul 15;107(1-2):61-6. doi: 10.1016/s0049-3848(02)00179-2.
Prothrombin time (PT) test systems require multicentre calibration for reliable International Sensitivity Index (ISI). Multicentre calibration of CoaguChek Mini and TAS PT-NC point-of-care test (POCT) systems is less precise than conventional PT testing. The aim of the present study was to determine the number of centres required to give reliable ISI and International Normalised Ratio (INR) with these two POCT whole blood PT monitors.
A simulation study, based on results of a 10-centre calibration exercise, was performed to assess reliability of ISI and INR when the number of centres was reduced from 10 to 2.
With both systems, the range of ISI and INR deviation increased as the number of centres was reduced. For the CoaguChek Mini, at least five centres were needed for satisfactory INR deviation in 95% of calibrations. With the TAS PT-NC, three centres gave satisfactory INR at this level. The number of centres required for multicentre calibration of these two POCT PT systems is greater than the two proposed by World Health Organisation (WHO) Guidelines for conventional PT testing.
凝血酶原时间（PT）检测系统需要进行多中心校准以获得可靠的国际敏感指数（ISI）。CoaguChek Mini和TAS PT-NC即时检测（POCT）系统的多中心校准不如传统PT检测精确。本研究的目的是确定使用这两种POCT全血PT监测仪获得可靠的ISI和国际标准化比值（INR）所需的中心数量。
基于一项10中心校准实验的结果进行了模拟研究，以评估当中心数量从10个减少到2个时ISI和INR的可靠性。
对于这两种系统，随着中心数量的减少，ISI和INR偏差的范围增大。对于CoaguChek Mini，在95%的校准中，至少需要五个中心才能获得令人满意的INR偏差。对于TAS PT-NC，三个中心在此水平下可获得令人满意的INR。这两种POCT PT系统进行多中心校准所需的中心数量大于世界卫生组织（WHO）传统PT检测指南建议的两个。
