体外诊断试剂工作校准品产品校准品互换性(基质效应)Excel计算模板

体外诊断试剂工作校准品/产品校准品互换性（基质效应）Excel计算模板,,,,,,,,,

依据：《GB/T21415-2008/ISO17511:2003体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性》及WS/T356-2011基质效应与互通性评估指南的方法,,,,,,,,,

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"《GB/T21415-2008/ISO17511:2003体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性》要求：

7.2：制造商应同时使用参考测量程序[4.2.2b)或d]和常规测量程序[4.2.2j]测量制造商工作校准品和一组相关的人体样品[4.2.2g]，评估工作校准品的互换性。

如果参考测量程序的结果x和常规测量程序的结果y的数学关系，对人体样品和制造商工作校准品无明显差别，则可以证明校准品的互换性。

参考测量程序测量工作校准品的的结果x和常规测量程序测量工作校准品的结果y值如以及参考测量程序测量一组相关的人体样品的的结果x和常规测量程序测量一组相关的人体样品的结果y值如下：",,,,,,,,,

备注：图中校准品结果在95%置信限内，两种方法检测工作校准品的数学关系一致，工作校准品的互换性满足要求。,,,,,,,,,

上图引用数据计算如下：,,,,,,,,,

工作校准品的互换性（基质效应）计算,,,,,,,,,

用工作校准品给产品校准品赋值，再用试剂盒测工作校准品+人体相关样本，结果如下,,,,,,,,,

序号,自产试剂盒（多次测量xi）,,,自产平均,参考试剂盒（多次测量yi）,,,参考平均,备注

1,67.71,65.88,67.10,66.90,70.35,63.04,73.33,68.91,人体相关标本

2,159.74,170.92,172.84,167.83,147.60,154.63,154.31,152.18,人体相关标本

3,30.85,27.86,33.32,30.68,29.99,29.00,32.15,30.38,人体相关标本

4,68.84,69.39,70.01,69.41,66.84,65.74,69.05,67.21,人体相关标本

5,197.51,205.81,198.30,200.54,188.23,217.26,186.05,197.18,人体相关标本

6,51.35,50.63,54.89,52.29,50.99,48.63,47.96,49.19,人体相关标本

7,68.13,61.39,74.19,67.90,68.06,61.59,67.65,65.77,人体相关标本

8,189.50,204.66,189.88,194.68,186.85,180.59,180.97,182.80,人体相关标本

9,89.81,94.75,95.11,93.22,81.64,97.98,97.17,92.26,人体相关标本

10,196.87,211.24,205.73,204.61,179.94,190.77,191.95,187.55,人体相关标本

11,96.58,96.87,103.73,99.06,91.65,88.27,105.08,95.00,人体相关标本

12,178.09,191.62,180.94,183.55,177.73,195.72,195.54,189.66,人体相关标本

13,187.50,198.19,201.56,195.75,192.38,193.69,189.75,191.94,人体相关标本

14,114.85,113.36,106.35,111.52,125.07,124.50,125.30,124.96,人体相关标本

15,109.98,118.01,104.92,110.97,113.06,102.17,117.57,110.93,人体相关标本

16,97.98,107.29,100.72,102.00,102.49,91.32,93.67,95.83,人体相关标本

17,81.63,85.63,86.69,84.65,88.08,80.98,88.24,85.77,人体相关标本

18,150.98,141.02,143.43,145.14,163.21,155.21,154.30,157.57,人体相关标本

19,83.61,76.84,91.47,83.97,82.94,90.80,85.70,86.48,人体相关标本

20,126.66,121.97,136.03,128.22,138.31,127.42,121.85,129.19,人体相关标本

21,104.53,108.71,95.02,102.75,107.14,110.80,108.50,108.81,人体相关标本

22,115.33,121.90,109.10,115.44,124.90,125.13,103.80,117.94,人体相关标本

23,34.48,36.07,33.24,34.60,35.65,35.76,35.38,35.60,人体相关标本

24,145.12,134.38,146.14,141.88,143.52,158.62,145.41,149.18,人体相关标本

25,27.32,26.28,28.55,27.38,26.50,29.83,26.31,27.55,人体相关标本

26,125.98,138.07,137.32,133.79,133.54,118.67,119.05,123.75,人体相关标本

27,130.06,137.99,120.57,129.54,119.66,133.44,125.51,126.20,人体相关标本

28,168.79,156.13,162.71,162.54,170.31,163.39,172.84,168.85,人体相关标本

29,137.84,125.85,125.02,129.57,128.74,151.21,128.60,136.18,人体相关标本

30,103.92,93.63,96.13,97.89,103.19,107.45,101.11,103.92,人体相关标本

31,24.53,26.40,26.58,25.84,22.95,27.05,27.25,25.75,校准品水平1

32,36.00,38.56,41.28,38.61,39.92,39.96,40.12,40.00,校准品水平2

33,73.68,79.36,74.24,75.76,85.92,75.84,81.12,80.96,校准品水平3

34,131.16,127.32,122.28,126.92,112.08,125.40,127.56,121.68,校准品水平4

34,173.92,162.72,156.48,164.37,149.44,153.12,165.28,155.95,校准品水平4

35,212.00,204.20,203.20,206.47,200.60,206.80,219.40,208.93,校准品水平5

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校准品互换性回归曲线中间计算结果,序号,自产均值xi,(xi-x平均)^2,对照均值yi,y回归,95%置信下限,95%置信上限,样品,

,1,66.90,2373.0,68.91,68.3,51.1,85.5,人体相关样本1,

,2,167.83,2727.3,152.18,165.7,148.4,183.0,人体相关样本2,

,3,30.68,7213.7,30.38,33.4,15.6,51.1,人体相关样本3,

,4,69.41,2134.1,67.21,70.7,53.5,87.9,人体相关样本4,

,5,200.54,7213.1,197.18,197.2,179.5,215.0,人体相关样本5,

,6,52.29,4009.4,49.19,54.2,36.8,71.6,人体相关样本6,

,7,67.90,2275.9,65.77,69.3,52.0,86.5,人体相关样本7,

,8,194.68,6252.1,182.80,191.6,173.9,209.2,人体相关样本8,

,9,93.22,501.2,92.26,93.7,76.7,110.7,人体相关样本9,

,10,204.61,7921.6,187.55,201.2,183.3,219.0,人体相关样本10,

,11,99.06,273.9,95.00,99.3,82.3,116.3,人体相关样本11,

,12,183.55,4615.9,189.66,180.8,163.3,198.3,人体相关样本12,

,13,195.75,6422.4,191.94,192.6,174.9,210.3,人体相关样本13,

,14,111.52,16.7,124.96,111.3,94.4,128.3,人体相关样本14,

,15,110.97,21.5,110.93,110.8,93.8,127.8,人体相关样本15,

,16,102.00,185.3,95.83,102.2,85.2,119.2,人体相关样本16,

,17,84.65,958.5,85.77,85.4,68.3,102.5,人体相关样本17,

,18,145.14,872.2,157.57,143.8,126.7,160.9,人体相关样本18,

,19,83.97,1000.9,86.48,84.8,67.7,101.9,人体相关样本19,

,20,128.22,159.0,129.19,127.5,110.5,144.5,人体相关样本20,

,21,102.75,165.3,108.81,102.9,85.9,119.9,人体相关样本21,

,22,115.44,0.0,117.94,115.1,98.1,132.1,人体相关样本22,

,23,34.60,6563.1,35.60,37.1,19.5,54.8,人体相关样本23,

,24,141.88,690.1,149.18,140.6,123.6,157.7,人体相关样本24,

,25,27.38,7783.9,27.55,30.2,12.4,48.0,人体相关样本25,

,26,133.79,330.5,123.75,132.8,115.8,149.9,人体相关样本26,

,27,129.54,194.0,126.20,128.7,111.7,145.7,人体相关样本27,

,28,162.54,2202.7,168.85,160.6,143.3,177.8,人体相关样本28,

,29,129.57,194.9,136.18,128.8,111.7,145.8,人体相关样本29,

,30,97.89,313.9,103.92,98.2,81.2,115.2,人体相关样本30,

,31,25.84,8059.2,25.75,28.7,10.8,46.5,校准品水平1,

,32,38.61,5928.5,40.00,41.0,23.4,58.6,校准品水平2,

,33,75.76,1588.0,80.96,76.8,59.7,94.0,校准品水平3,

,34,126.92,127.9,121.68,126.2,109.2,143.2,校准品水平4,

,34,164.37,2377.9,155.95,162.3,145.1,179.6,校准品水平5,

,35,206.47,8255.0,208.93,202.9,185.1,220.8,校准品水平6,

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产品校准品的互换性计算,,,,,,,,,

"《GB/T21415-2008/ISO17511:2003体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性》要求：

国标7.3：应同时使用参考程序和经校准的常规程序测量准备由常规测量程序测量的某类型的一组实际样品，将结果比较，以证实制造商产品校准品的互换性。

样品应是原始的、最好来自各个单一共同的、未添加任何物质的人体样品，它们的值应尽可能分布于被测量特定的测量区间的整个范围。

7.4：应对每个样品用参考和校准的常规程序进行重复测量。为达到计量学的溯源性，常规程序的结果应与参考程序的结果相关，如一定概率下线性回归的斜率为1，截距为0。

参考测量程序测量一组人体实际样品的的结果x和常规测量程序测量一组人体实际样品的结果y值如下：",,,,,,,,,

备注：图中校准品结果在95%置信限内，两种方法检测工作校准品的数学关系一致，工作校准品的互换性满足要求。,,,,,,,,,

序号,自产试剂盒（多次测量xi）,,,自产平均,参考试剂盒（多次测量yi）,,,参考平均,备注

1,160.66,159.21,162.59,160.82,165.96,147.81,155.68,156.48,人体实际标本

2,180.60,177.71,179.34,179.22,186.74,195.77,191.44,191.32,人体实际标本

3,186.84,200.48,198.61,195.31,181.98,202.16,187.59,190.58,人体实际标本

4,108.87,113.55,114.64,112.35,105.60,100.81,113.66,106.69,人体实际标本

5,130.76,134.81,117.95,127.84,130.50,133.51,132.46,132.16,人体实际标本

6,99.09,95.42,108.21,100.91,99.09,97.11,101.86,99.35,人体实际标本

7,152.31,152.31,148.65,151.09,140.43,141.65,158.86,146.98,人体实际标本

8,146.84,151.39,155.94,151.39,142.14,132.16,153.59,142.63,人体实际标本

9,134.46,123.30,133.52,130.43,137.28,126.12,144.54,135.98,人体实际标本

10,140.70,132.40,154.49,142.53,143.23,145.06,136.76,141.68,人体实际标本

11,80.33,79.04,77.12,78.83,72.38,76.39,80.49,76.42,人体实际标本

12,110.06,117.21,103.24,110.17,119.19,100.93,100.26,106.79,人体实际标本

13,130.06,118.09,130.32,126.16,131.75,134.87,128.76,131.79,人体实际标本

14,129.60,140.62,118.71,129.64,131.03,134.14,122.47,129.21,人体实际标本

15,77.64,72.59,80.36,76.86,74.22,78.57,84.94,79.24,人体实际标本

16,83.07,88.64,83.15,84.95,87.47,75.26,88.64,83.79,人体实际标本

17,38.53,40.19,41.27,40.00,37.61,37.95,40.84,38.80,人体实际标本

18,78.10,71.31,71.15,73.52,75.52,82.55,81.69,79.92,人体实际标本

19,162.28,172.83,157.90,164.34,150.43,160.17,159.03,156.54,人体实际标本

20,122.34,131.76,123.56,125.89,126.50,111.57,118.06,118.71,人体实际标本

21,133.21,143.73,132.28,136.41,120.95,143.60,122.02,128.86,人体实际标本

22,68.27,68.20,62.47,66.31,71.48,70.73,73.