Gogstad G O, Dahl K H, Christophersen A, Bjerke A
Clin Chem. 1986 Oct;32(10):1857-62.
Two thromboplastin reagents ("Thrombotest" and "Normotest Automated") were used in evaluation of an automated method for determination of prothrombin time based on turbidimetric measurement of clot formation in a centrifugal analyzer. We used 60 plasma samples from patients with various diseases or being treated with oral anticoagulant and 16 normal plasma samples. Prothrombin times were calculated by a computer connected to the analyzer, a reading being made at either a certain per cent increase in total absorbance or a fixed absorbance increase. Both correlated well with the manual method (r = 0.98-0.99). The reading points best fitting the manually obtained data were estimated by minimizing the residual sum of squares in regression analyses performed at various absorbance increases. The per cent reading was better in this respect. Normotest Automated could be nearly perfectly related to the manual method, whereas Thrombotest showed a (negligibly) small deviation. Reproducibility was good within run (CV less than or equal to 3.2%) as well as between batch of the reagents, as assessed from variation in INR (CV less than or equal to 4.9%). We conclude that turbidimetry of clot formation may be validly used in automation of the prothrombin-time test. The equipment needed and the total time per analysis are about as for chromogenic substrate methods, but reagent cost is considerably lower.
使用两种凝血活酶试剂(“血栓试验”和“自动正常试验”)评估一种基于离心分析仪中凝块形成的比浊法测定凝血酶原时间的自动化方法。我们使用了来自患有各种疾病或正在接受口服抗凝剂治疗的患者的60份血浆样本以及16份正常血浆样本。凝血酶原时间由连接到分析仪的计算机计算得出,读数是在总吸光度增加一定百分比或固定吸光度增加时进行的。两者与手工方法的相关性都很好(r = 0.98 - 0.99)。通过在不同吸光度增加时进行回归分析,使残差平方和最小化来估计最符合手工获得数据的读数点。在这方面,百分比读数更好。自动正常试验与手工方法几乎完全相关,而血栓试验显示出(可忽略不计的)小偏差。根据国际标准化比值(INR)的变化评估,批内(CV≤3.2%)以及试剂批次间的重复性都很好(CV≤4.9%)。我们得出结论,凝块形成的比浊法可有效地用于凝血酶原时间试验的自动化。所需设备和每次分析的总时间与发色底物法大致相同,但试剂成本要低得多。