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  • ASTM D6708-16
    測量某種材料相同性能的兩種試驗方法之間預期一致性的統計評價和改進的標準實施規程

    Standard Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport to Measure the Same Property of a Material


     

     

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    標準號
    ASTM D6708-16
    發布
    2016年
    發布單位
    美國材料與試驗協會
    替代標準
    ASTM D6708-16a
    當前最新
    ASTM D6708-24
     
     
    適用范圍

    5.1 This practice can be used to determine if a constant, proportional, or linear bias correction can improve the degree of agreement between two methods that purport to measure the same property of a material.

    5.2 The bias correction developed in this practice can be applied to a single result (X) obtained from one test method (method X) to obtain a predicted result ( Y^) for the other test method (method Y).

    Note 6: Users are cautioned to ensure that Y^ is within the scope of method Y before its use.

    5.3 The between methods reproducibility established by this practice can be used to construct an interval around Y^ that would contain the result of test method Y, if it were conducted, with about 958201;% confidence.

    5.4 This practice can be used to guide commercial agreements and product disposition decisions involving test methods that have been evaluated relative to each other in accordance with this practice.

    5.5 The magnitude of a statistically detectable bias is directly related to the uncertainties of the statistics from the experimental study. These uncertainties are related to both the size of the data set and the precision of the processes being studied. A large data set, or, highly precise test method(s), or both, can reduce the uncertainties of experimental statistics to the point where the “statistically detectable” bias can become “trivially small,” or be considered of no practical consequence in the intended use of the test method under study. Therefore, users of this practice are advised to determine in advance as to the magnitude of bias correction below which they would consider it to be unnecessary, or, of no practical concern for the intended application prior to execution of this practice.

    Note 7: It should be noted that the determination of this minimum bias of no practical concern is not a statistical decision, but rather, a subjective decision that is directly dependent on the application require......

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    藥監局:基因測序儀臨床評價注冊審查指導原則等3項

    (6)統計分析  應選擇合適統計方法對臨床試驗結果進行統計分析,對于試驗醫療器械與參考方法/已上市同類產品一致性評價,一般選擇2×2四格表形式總結兩種產品檢測結果,并據此計算靈敏度/特異度、陽性/陰性符合率、Kappa值等指標及其95%置信區間。  對于不一致樣本,應進行原因分析。如臨床試驗方案規定采用其他方法進行確認,則確認結果不應納入統計分析。  ...

    國家藥監局發文 疫苗一致性評價來了!

    臨床一致性比較批次研究數據將為質量標準中關鍵檢定項目的限度(如抗原含量/效價、病毒滴度上下限范圍等)有效性下限安全性上限提供支持,保證質量標準科學、合理,從而進一步保證上市疫苗安全有效,質量可控。  免疫原性評價指標標準參照前述隨機對照臨床試驗。  ...

    HIV初篩實驗室室間質量評價標準操作程序

    免疫測定方法靈敏度特異性要比生化方法高得多,因此QC手段不能照搬生化模式。質量控制是監視ELISA操作全過程,排除誤差,維持標準化操作一個管理過程。這一過程是通過一個反饋環路進行:1、確定控制對象;2、規定控制對象標準預期值);3、制定或選擇控制方法手段;4、測量實際數據;5、比較或較對實際數據與預期之間差異,并說明原因。...


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