Lawrie A S, Kitchen S, Purdy G, Mackie I J, Preston F E, Machin S J
Department of Haematology, University College London, UK.
Clin Lab Haematol. 1998 Jun;20(3):179-86. doi: 10.1046/j.1365-2257.1998.00122.x.
We present a two centre study designed to assess the sensitivity of Actin FS and Actin FSL to deficiencies of factor VIII, IX, XI or XII. The study was undertaken at two centres to avoid bias due to the investigations being undertaken on one analyser. Samples from patients with a factor VIII (n = 36, F VIII = < 1.0-50 iu/dl), factor IX (n = 22, F IX = 2-48 iu/dl), factor XI (n = 23, F XI = 5-50 u/dl) or a factor XII (n = 18, F XII = 1-50 u/dl) deficient state were studied. Activated partial thromboplastin times (APTT) were determined using two batches of Actin FS and of Actin FSL; comparison of APTT results between centres was facilitated by the conversion of clotting times to ratios (test divided by geometric mean normal clotting time). APTT ratios were considered to be elevated if greater than two standard deviations above the mean normal. The factor deficient status of each sample was verified by assaying all samples for factors VIII, IX, XI and XII. Clotting factor assays were performed on a Sysmex CA-1000 fitted with research software, which permitted the auto-dilution and testing of three serial dilution of both a reference preparation and each patient's sample. Assay results were calculated using parallel-line Bioassay principles. This procedure allowed for variation in clotting times due to the effect of temporal drift of any of the reagents within the assay system. Actin FS and Actin FSL demonstrate acceptable sensitivity to factor VIII deficiency, however, both reagents failed to detect a large proportion of factor XI (17.4% and 30.4% of samples, respectively) and factor XII (66.7% and 72.2%, respectively) deficiencies. The detection rate with Actin FSL for factor IX deficiency was also poor (36.4% not detected). As factor IX and XI deficiencies are both associated with haemorrhagic disorders, the inability of these reagents to detect such abnormalities gave cause for concern.
我们开展了一项双中心研究，旨在评估Actin FS和Actin FSL对凝血因子VIII、IX、XI或XII缺乏的敏感性。该研究在两个中心进行，以避免因在一台分析仪上进行检测而产生偏差。研究了来自凝血因子VIII缺乏（n = 36，F VIII = < 1.0 - 50 iu/dl）、凝血因子IX缺乏（n = 22，F IX = 2 - 48 iu/dl）、凝血因子XI缺乏（n = 23，F XI = 5 - 50 u/dl）或凝血因子XII缺乏（n = 18，F XII = 1 - 50 u/dl）状态患者的样本。使用两批Actin FS和Actin FSL测定活化部分凝血活酶时间（APTT）；通过将凝血时间转换为比率（测试值除以几何平均正常凝血时间），便于比较两个中心之间的APTT结果。如果APTT比率高于正常均值两个标准差以上，则认为其升高。通过对所有样本进行凝血因子VIII、IX、XI和XII检测，验证每个样本的凝血因子缺乏状态。在配备研究软件的Sysmex CA - 1000上进行凝血因子检测，该软件允许对参考制剂和每个患者样本的三个系列稀释液进行自动稀释和检测。使用平行线生物测定原理计算检测结果。该程序考虑到了由于检测系统内任何试剂的时间漂移效应导致的凝血时间变化。Actin FS和Actin FSL对凝血因子VIII缺乏表现出可接受的敏感性，然而，两种试剂均未能检测到很大比例的凝血因子XI缺乏（分别为样本的17.4%和30.4%）和凝血因子XII缺乏（分别为66.7%和72.2%）。Actin FSL对凝血因子IX缺乏的检测率也很低（36.4%未检测到）。由于凝血因子IX和XI缺乏均与出血性疾病相关，这些试剂无法检测到此类异常令人担忧。
