van den Besselaar A M, Bertina R M
Department of Haematology, Leiden University Hospital, The Netherlands.
Thromb Haemost. 1993 Jan 11;69(1):35-40.
Four thromboplastin reagents were tested by 18 laboratories in Europe, North-America, and Australasia, according to a detailed protocol. One thromboplastin was the International Reference Preparation for ox brain thromboplastin combined with adsorbed bovine plasma (coded OBT/79), and the second was a certified reference material for rabbit brain thromboplastin, plain (coded CRM 149R). The other two thromboplastin reagents were another rabbit plain brain thromboplastin (RP) with a lower ISI than CRM 149R and a rabbit brain thromboplastin combined with adsorbed bovine plasma (RC). Calibration of the latter two reagents was performed according to methods recommended by the World Health Organization (W.H.O.). The purpose of this study was to answer the following questions: 1) Is the calibration of the RC reagent more precise against the bovine/combined (OBT/79) than against the rabbit/plain reagent (CRM 149R)? 2) Is the precision of calibration influenced by the magnitude of the International Sensitivity Index (ISI)? The lowest inter-laboratory variation of ISI was observed in the calibration of the rabbit/plain reagent (RP) against the other rabbit/plain reagent (CRM 149R) (CV 1.6%). The highest inter-laboratory variation was obtained in the calibration of rabbit/plain (RP) against bovine/combined (OBT/79) (CV 5.1%). In the calibration of the rabbit/combined (RC) reagent, there was no difference in precision between OBT/79 (CV 4.3%) and CRM 149R (CV 4.2%). Furthermore, there was no significant difference in the precision of the ISI of RC obtained with CRM 149R (ISI = 1.343) and the rabbit/plain (RP) reagent with ISI = 1.14. In conclusion, the calibration of RC could be performed with similar precision with either OBT/79 or CRM 149R, or RP.(ABSTRACT TRUNCATED AT 250 WORDS)
欧洲、北美和澳大拉西亚的18个实验室按照详细方案对四种凝血活酶试剂进行了检测。一种凝血活酶是国际参考制剂，即与吸附牛血浆混合的牛脑凝血活酶（编码为OBT/79），第二种是兔脑凝血活酶的认证参考物质，普通型（编码为CRM 149R）。另外两种凝血活酶试剂是国际敏感度指数（ISI）低于CRM 149R的另一种兔普通脑凝血活酶（RP），以及与吸附牛血浆混合的兔脑凝血活酶（RC）。后两种试剂的校准按照世界卫生组织（W.H.O.）推荐的方法进行。本研究的目的是回答以下问题：1）相对于兔/普通试剂（CRM 149R），RC试剂以牛/混合（OBT/79）为对照进行校准时是否更精确？2）校准的精密度是否受国际敏感度指数（ISI）大小的影响？在以另一种兔/普通试剂（CRM 149R）为对照校准兔/普通试剂（RP）时，观察到最低的实验室间ISI变异（CV 1.6%）。在以牛/混合（OBT/79）为对照校准兔/普通（RP）时，获得了最高的实验室间变异（CV 5.1%）。在校准兔/混合（RC）试剂时，以OBT/79（CV 4.3%）和CRM 149R（CV 4.2%）为对照，精密度没有差异。此外，用CRM 149R（ISI = 1.343）和ISI = 1.14的兔/普通（RP）试剂获得的RC的ISI精密度也没有显著差异。总之，RC的校准以OBT/79或CRM 149R或RP为对照时，均可获得相似的精密度。（摘要截选至250词）
