Tan K, Booth D, Newell S J, Dear P R F, Hughes C, Richards M
Neonatal Unit, St James's University Hospital, Leeds, UK.
Clin Lab Haematol. 2006 Apr;28(2):117-21. doi: 10.1111/j.1365-2257.2006.00765.x.
The aim of this validation study was to compare prothrombin time (PT) and activated partial thromboplastin time (APTT) results from a point-of-care testing (POCT) device (Rapidpoint Coag) with those from standard laboratory tests. The subjects were newborn infants needing coagulation screen for any clinical indications within a regional neonatal intensive care unit. The level of agreement between POCT and laboratory measurements of PT and APTT was determined. For PT: the bias was from -7.6 to 12.4 s and precision was 5.0 s. For the detection of prolonged PT at a level of 16 s, the sensitivity was 0.70, specificity was 0.57 and the positive predictive value (PPV) was 0.62. For APTT: the bias was from -39.1 to 23.7 s, and precision was 15.7 s. For the detection of prolonged APTT at a level of 55 s, the sensitivity was 0.80, specificity was 0.95 and the PPV was 0.80. The POCT device tested has limited utility as a cot-side device for screening for a prolongation of the APTT in the newborn but is not sensitive for screening for prolongation of the PT.
本验证研究的目的是比较即时检验（POCT）设备（Rapidpoint Coag）测得的凝血酶原时间（PT）和活化部分凝血活酶时间（APTT）结果与标准实验室检测结果。研究对象为某地区新生儿重症监护病房内因任何临床指征需要进行凝血筛查的新生儿。确定了POCT与PT和APTT实验室测量结果之间的一致性水平。对于PT：偏差为-7.6至12.4秒，精密度为5.0秒。对于检测PT延长至16秒的情况，灵敏度为0.70，特异性为0.57，阳性预测值（PPV）为0.62。对于APTT：偏差为-39.1至23.7秒，精密度为15.7秒。对于检测APTT延长至55秒的情况，灵敏度为0.80，特异性为0.95，PPV为0.80。所测试的POCT设备作为床边设备用于筛查新生儿APTT延长的效用有限，但对筛查PT延长不敏感。
