CHINA 凝血因子检测
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Dilution range: Should cover the linear part of dilution curve as widely as possible 稀释范围：应该尽可能宽地包括稀释曲线的线 形部分
Number of dilutions: 稀释度数量 Standard CurveAt least three dilutions（标准曲线-至少三个稀释度） Test curveat least two and preferably three points（检测曲线-至少两个，最好 三个点）
Equal volumes of plasma dilution and Factor VIII-deficient plasma are mixed together and an APTT is performed for each mixture 等体积混合血浆稀释液和乏因子VIII血浆，随后检测每个混合体的APTT。
suggest the
presence of an inhibitor非平行的 相交线提示有抑 制物的存在
力学研究
The Factor VIII Assay Problem 因子VIII检测的问题
Number of published studies showing FVIII levels in post-infusion samples to be 20-50% higher when measured by chromogenic as opposed to 1-stage assay. 一些已发表的研究显示，用显色法检测输注后样本的因子 VIII水平要比一期法检测高20-50%
Coagulation Factor Assay 凝血因子检测
Why do we measure FVIII 为什么我们要做FVIII检测
Diagnosis of Haemophilia and VWD 诊断血友病和VWD
Factor VIII Concentrate potency 因子 VIII浓缩剂的强度 Post-Infusion recovery samples 输注后恢复的标本 Thrombophilia 血栓 Pharmacokinetic studies in Haemophilia 血友病的药代动
Over treatment (cost) 过度治疗（花费）
Standardisation of results between different laboratories. 不同实验室之间结果标准化
Clotting Factor Assays 凝血因子检测
In vitro assays that measure the coagulant activity of the inactive circulating protein (zymogen) by artificially simulating in vivo activation and then measuring the response. 体外检测未活化的循环蛋白（酶原）的凝血活性可通过人 工刺激其类似体内的活化，随后检测其反应。
One-Stage Assay 一期法 Two-Stage Assay 二期法 Chromogenic Assay 显色法
One-Stage Factor VIII Bioassay
（一期法因子VIII生物学检测）
Based on the APTT First described by Langdell et al 1953 By studying ratios of Haem A and NP that the APTT is linearly related to the logarithm of the FVIII concentration 基于APTT检测。首次由Langdell 等人在1953年发表。通过研究Haem A 和 NP 比值，发现APTT与FVIII 浓度的对数呈线性相关。
LLeabharlann Baidug Dose
One-Stage Factor VIII Bioassay
T S
25% 100%
Factor VIII Concentration (Log )
One-Stage Factor VIII Bioassay
T S
50% 100%
Non-parallel
converging lines
Correction of the APTT of a plasma severely deficient in factor VIII by adding dilutions of Std or test plasma. 通过在严重缺乏因子VIII的血浆中加入不同稀释度的标准或测试血浆稀释液， 纠正其APTT
Also differences in pharmacokinetic data 药代动力学的数 据也存在差异
Most pronounced in BDD-rFVIII (Refacto) 最明显的是BDD-rFVIII
Clinical Ramifications 临床后果
Under treatment (risk of bleeding) 缺乏治疗（出血风险）
Coagulation times are inversely proportional to the factor VIII concentration 凝血时间与因子VIII的浓度成反比。
Bioassays: Design生物学检测法：设计
Ensures that Standard and Test preparations are compared under identical conditions, taking into account any factors which may lead to biased potency estimates.确保标准样品和检测样品在相同条件下 进行比较，考虑所有可能引起测试偏倚的因素
Number of dilutions: 稀释度数量 Standard CurveAt least three dilutions（标准曲线-至少三个稀释度） Test curveat least two and preferably three points（检测曲线-至少两个，最好 三个点）
Equal volumes of plasma dilution and Factor VIII-deficient plasma are mixed together and an APTT is performed for each mixture 等体积混合血浆稀释液和乏因子VIII血浆，随后检测每个混合体的APTT。
suggest the
presence of an inhibitor非平行的 相交线提示有抑 制物的存在
力学研究
The Factor VIII Assay Problem 因子VIII检测的问题
Number of published studies showing FVIII levels in post-infusion samples to be 20-50% higher when measured by chromogenic as opposed to 1-stage assay. 一些已发表的研究显示，用显色法检测输注后样本的因子 VIII水平要比一期法检测高20-50%
Coagulation Factor Assay 凝血因子检测
Why do we measure FVIII 为什么我们要做FVIII检测
Diagnosis of Haemophilia and VWD 诊断血友病和VWD
Factor VIII Concentrate potency 因子 VIII浓缩剂的强度 Post-Infusion recovery samples 输注后恢复的标本 Thrombophilia 血栓 Pharmacokinetic studies in Haemophilia 血友病的药代动
Over treatment (cost) 过度治疗（花费）
Standardisation of results between different laboratories. 不同实验室之间结果标准化
Clotting Factor Assays 凝血因子检测
In vitro assays that measure the coagulant activity of the inactive circulating protein (zymogen) by artificially simulating in vivo activation and then measuring the response. 体外检测未活化的循环蛋白（酶原）的凝血活性可通过人 工刺激其类似体内的活化，随后检测其反应。
One-Stage Assay 一期法 Two-Stage Assay 二期法 Chromogenic Assay 显色法
One-Stage Factor VIII Bioassay
（一期法因子VIII生物学检测）
Based on the APTT First described by Langdell et al 1953 By studying ratios of Haem A and NP that the APTT is linearly related to the logarithm of the FVIII concentration 基于APTT检测。首次由Langdell 等人在1953年发表。通过研究Haem A 和 NP 比值，发现APTT与FVIII 浓度的对数呈线性相关。
LLeabharlann Baidug Dose
One-Stage Factor VIII Bioassay
T S
25% 100%
Factor VIII Concentration (Log )
One-Stage Factor VIII Bioassay
T S
50% 100%
Non-parallel
converging lines
Correction of the APTT of a plasma severely deficient in factor VIII by adding dilutions of Std or test plasma. 通过在严重缺乏因子VIII的血浆中加入不同稀释度的标准或测试血浆稀释液， 纠正其APTT
Also differences in pharmacokinetic data 药代动力学的数 据也存在差异
Most pronounced in BDD-rFVIII (Refacto) 最明显的是BDD-rFVIII
Clinical Ramifications 临床后果
Under treatment (risk of bleeding) 缺乏治疗（出血风险）
Coagulation times are inversely proportional to the factor VIII concentration 凝血时间与因子VIII的浓度成反比。
Bioassays: Design生物学检测法：设计
Ensures that Standard and Test preparations are compared under identical conditions, taking into account any factors which may lead to biased potency estimates.确保标准样品和检测样品在相同条件下 进行比较，考虑所有可能引起测试偏倚的因素