A Comparison of INRs after Local Calibration of Thromboplastin International Sensitivity Indexes
A Comparison of INRs after Local Calibration of Thromboplastin International Sensitivity Indexes
复制标题
凝血活酶国际敏感性指数本地校准后 INR 的比较
DOI：
10.29074/ascls.15.2.91
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
D. Mcglasson
中科院分区：
文献类型：
--
作者：
D. Mcglasson
在美国，大约有300种试剂/仪器组合用于测定凝血酶原时间/国际标准化比值（PT/INR）。制造商和实验室一直在努力确保其凝血活酶的国际敏感性指数（ISI）准确地测定PT/INR。目的：本研究报告了使用机械STA自动凝血分析仪（Diagnostica-Stago Inc.）以及两台光电凝血分析仪BCS（Dade-Behring）和CA-540（Sysmex）。产品设计：本研究中使用了Neoplastine CI+（CI+）（Diagnostica-Stago Inc）、凝血活酶C+（TC+）、Thromborel S（TRS）和Innovin（I）（Dade-Behring）。使用来自25名正常个体的样本，确定每种试剂/仪器组合的平均正常PT（MNPT）。对于带TC+、TRS和I的STA，制造商仪器特定ISI值不可用。CA 540没有CI+的ISI值，BCS系统没有制造商指定的TC+和I的ISI值;这两个系统使用通用的光学和机械ISI制造商值。使用冷冻血浆校准品进行当地现场校准，以确定每种促凝血酶原激酶的ISI值。校准后，使用制造商ISI和当地校准ISI对每种试剂/仪器系统组合的95份患者样本进行分析，以确定INR结果。患者：采集样本的患者包括5名狼疮抗凝剂患者，30名肝素治疗患者和60名香豆素治疗患者。研究结果：对于正常样本INR，制造商与当地校准ISI之间的差异范围为0.9%至18.9%，对于患者样本INR，制造商与当地校准ISI之间的差异范围为0.8%至16.4%。INR值具有临床显著差异（差异>10.0%）的患者标本数量（或比例）范围从几种试剂组合的零到几种其他组合的一半以上（或>50.0%）。结论：我们的研究结果表明，通过本地校准ISI值，每个实验室在进行PT/INR测定时可以消除不同试剂/仪器系统之间ISI值的变异性和猜测，并可能提高患者PT/INR结果的临床准确性。缩略语：CI+ =肿瘤素CI+; INR =国际标准化比值; IRP =国际参比制剂; ISI =国际敏感性指数; MNPT =平均正常凝血酶原时间; OAT =口服抗凝治疗; PIVKAS =维生素K拮抗剂诱导的蛋白质; PT =凝血酶原时间; TC+ =凝血活酶C+; TRS = Thromborel S; WHO =世界卫生组织。
There are approximately 300 reagent/instrument combinations for performing prothrombin times/international normalized ratios (PT/INR) in the United States. Manufacturers and laboratories continually struggle to ensure that the International Sensitivity Index (ISI) of their thromboplastin is accurate for assaying PT/INR. OBJECTIVE: This study reports the feasibility of a new method to locally calibrate ISI of thromboplastin using the mechanical STA automated coagulation analyzer (Diagnostica-Stago Inc.) and two photo-optic coagulation analyzers, the BCS (Dade-Behring) and CA-540 (Sysmex). DESIGN: Neoplastine CI+ (CI+) (Diagnostica-Stago Inc); Thromboplastin C+ (TC+); Thromborel S (TRS); and Innovin (I) (Dade-Behring) were used in this study. A mean normal PT (MNPT) was determined for each reagent/instrument combination using samples from 25 normal individuals. Manufacturer instrument specific ISI values were not available for the STA with TC+, TRS and I. The CA540 had no ISI value for CI+ and the BCS system had no manufacturer assigned ISI values for TC+ and I; generic photo-optic and mechanical ISI manufacturer values were used for these two systems. Local on-site calibration was performed using frozen plasma calibrators to determine ISI values for each thromboplastin. Post-calibration, 95 patient samples were assayed for each reagent/instrument system combination using the manufacturer ISI and the local calibrated ISI to determine the INR result. PATIENTS: Patients from whom samples were obtained included five with a lupus anticoagulant, 30 on heparin therapy, and 60 on coumadin therapy. RESULTS: Differences between manufacturer versus local calibrated ISI ranged from 0.9% to 18.9% for normal sample INRs and from 0.8% to 16.4% for patient sample INRs. The number (or proportion) of patient specimens with clinically significantly different INR values (>10.0% difference) ranged from zero for several reagent combinations to more than half (or >50.0%) of those tested for several other combinations. CONCLUSION: Our results indicated that by locally calibrating ISI values, each laboratory may eliminate variability and guesswork between different reagent/instrument systems for ISI values when performing PT/INR assays and potentially improve the clinical accuracy of their patients' PT/INR results. ABBREVIATIONS: CI+ = Neoplastine CI+; INR = international normalized ratio; IRP = international reference preparation; ISI = international sensitivity index; MNPT = mean normal prothrombin time; OAT = oral anticoagulant therapy; PIVKAS = proteins induced by Vitamin K antagonists; PT = prothrombin time; TC+ = Thromboplastin C+; TRS = Thromborel S; WHO = World Health Organization.
制造商确定的、仪器特定的用于计算国际标准化比率的国际灵敏度指数值的可靠性。
影响因子：
3.5
作者：
Cunningham,MT;Johnson,GF;Pennell,BJ;Olson,JD
通讯作者：
Olson,JD