體外診斷試劑工作校準(zhǔn)品產(chǎn)品校準(zhǔn)品互換性(基質(zhì)效應(yīng))Excel計(jì)算模板

體外診斷試劑工作校準(zhǔn)品/產(chǎn)品校準(zhǔn)品互換性（基質(zhì)效應(yīng)）Excel計(jì)算模板,,,,,,,,,

依據(jù)：《GB/T21415-2008/ISO17511:2003體外診斷醫(yī)療器械生物樣品中量的測量校準(zhǔn)品和控制物質(zhì)賦值的計(jì)量學(xué)溯源性》及WS/T356-2011基質(zhì)效應(yīng)與互通性評(píng)估指南的方法,,,,,,,,,

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"《GB/T21415-2008/ISO17511:2003體外診斷醫(yī)療器械生物樣品中量的測量校準(zhǔn)品和控制物質(zhì)賦值的計(jì)量學(xué)溯源性》要求：

7.2：制造商應(yīng)同時(shí)使用參考測量程序[4.2.2b)或d]和常規(guī)測量程序[4.2.2j]測量制造商工作校準(zhǔn)品和一組相關(guān)的人體樣品[4.2.2g]，評(píng)估工作校準(zhǔn)品的互換性。

如果參考測量程序的結(jié)果x和常規(guī)測量程序的結(jié)果y的數(shù)學(xué)關(guān)系，對(duì)人體樣品和制造商工作校準(zhǔn)品無明顯差別，則可以證明校準(zhǔn)品的互換性。

參考測量程序測量工作校準(zhǔn)品的的結(jié)果x和常規(guī)測量程序測量工作校準(zhǔn)品的結(jié)果y值如以及參考測量程序測量一組相關(guān)的人體樣品的的結(jié)果x和常規(guī)測量程序測量一組相關(guān)的人體樣品的結(jié)果y值如下：",,,,,,,,,

備注：圖中校準(zhǔn)品結(jié)果在95%置信限內(nèi)，兩種方法檢測工作校準(zhǔn)品的數(shù)學(xué)關(guān)系一致，工作校準(zhǔn)品的互換性滿足要求。,,,,,,,,,

上圖引用數(shù)據(jù)計(jì)算如下：,,,,,,,,,

工作校準(zhǔn)品的互換性（基質(zhì)效應(yīng)）計(jì)算,,,,,,,,,

用工作校準(zhǔn)品給產(chǎn)品校準(zhǔn)品賦值，再用試劑盒測工作校準(zhǔn)品+人體相關(guān)樣本，結(jié)果如下,,,,,,,,,

序號(hào),自產(chǎn)試劑盒（多次測量xi）,,,自產(chǎn)平均,參考試劑盒（多次測量yi）,,,參考平均,備注

1,67.71,65.88,67.10,66.90,70.35,63.04,73.33,68.91,人體相關(guān)標(biāo)本

2,159.74,170.92,172.84,167.83,147.60,154.63,154.31,152.18,人體相關(guān)標(biāo)本

3,30.85,27.86,33.32,30.68,29.99,29.00,32.15,30.38,人體相關(guān)標(biāo)本

4,68.84,69.39,70.01,69.41,66.84,65.74,69.05,67.21,人體相關(guān)標(biāo)本

5,197.51,205.81,198.30,200.54,188.23,217.26,186.05,197.18,人體相關(guān)標(biāo)本

6,51.35,50.63,54.89,52.29,50.99,48.63,47.96,49.19,人體相關(guān)標(biāo)本

7,68.13,61.39,74.19,67.90,68.06,61.59,67.65,65.77,人體相關(guān)標(biāo)本

8,189.50,204.66,189.88,194.68,186.85,180.59,180.97,182.80,人體相關(guān)標(biāo)本

9,89.81,94.75,95.11,93.22,81.64,97.98,97.17,92.26,人體相關(guān)標(biāo)本

10,196.87,211.24,205.73,204.61,179.94,190.77,191.95,187.55,人體相關(guān)標(biāo)本

11,96.58,96.87,103.73,99.06,91.65,88.27,105.08,95.00,人體相關(guān)標(biāo)本

12,178.09,191.62,180.94,183.55,177.73,195.72,195.54,189.66,人體相關(guān)標(biāo)本

13,187.50,198.19,201.56,195.75,192.38,193.69,189.75,191.94,人體相關(guān)標(biāo)本

14,114.85,113.36,106.35,111.52,125.07,124.50,125.30,124.96,人體相關(guān)標(biāo)本

15,109.98,118.01,104.92,110.97,113.06,102.17,117.57,110.93,人體相關(guān)標(biāo)本

16,97.98,107.29,100.72,102.00,102.49,91.32,93.67,95.83,人體相關(guān)標(biāo)本

17,81.63,85.63,86.69,84.65,88.08,80.98,88.24,85.77,人體相關(guān)標(biāo)本

18,150.98,141.02,143.43,145.14,163.21,155.21,154.30,157.57,人體相關(guān)標(biāo)本

19,83.61,76.84,91.47,83.97,82.94,90.80,85.70,86.48,人體相關(guān)標(biāo)本

20,126.66,121.97,136.03,128.22,138.31,127.42,121.85,129.19,人體相關(guān)標(biāo)本

21,104.53,108.71,95.02,102.75,107.14,110.80,108.50,108.81,人體相關(guān)標(biāo)本

22,115.33,121.90,109.10,115.44,124.90,125.13,103.80,117.94,人體相關(guān)標(biāo)本

23,34.48,36.07,33.24,34.60,35.65,35.76,35.38,35.60,人體相關(guān)標(biāo)本

24,145.12,134.38,146.14,141.88,143.52,158.62,145.41,149.18,人體相關(guān)標(biāo)本

25,27.32,26.28,28.55,27.38,26.50,29.83,26.31,27.55,人體相關(guān)標(biāo)本

26,125.98,138.07,137.32,133.79,133.54,118.67,119.05,123.75,人體相關(guān)標(biāo)本

27,130.06,137.99,120.57,129.54,119.66,133.44,125.51,126.20,人體相關(guān)標(biāo)本

28,168.79,156.13,162.71,162.54,170.31,163.39,172.84,168.85,人體相關(guān)標(biāo)本

29,137.84,125.85,125.02,129.57,128.74,151.21,128.60,136.18,人體相關(guān)標(biāo)本

30,103.92,93.63,96.13,97.89,103.19,107.45,101.11,103.92,人體相關(guān)標(biāo)本

31,24.53,26.40,26.58,25.84,22.95,27.05,27.25,25.75,校準(zhǔn)品水平1

32,36.00,38.56,41.28,38.61,39.92,39.96,40.12,40.00,校準(zhǔn)品水平2

33,73.68,79.36,74.24,75.76,85.92,75.84,81.12,80.96,校準(zhǔn)品水平3

34,131.16,127.32,122.28,126.92,112.08,125.40,127.56,121.68,校準(zhǔn)品水平4

34,173.92,162.72,156.48,164.37,149.44,153.12,165.28,155.95,校準(zhǔn)品水平4

35,212.00,204.20,203.20,206.47,200.60,206.80,219.40,208.93,校準(zhǔn)品水平5

,,,,,,,,,,

校準(zhǔn)品互換性回歸曲線中間計(jì)算結(jié)果,序號(hào),自產(chǎn)均值xi,(xi-x平均)^2,對(duì)照均值yi,y回歸,95%置信下限,95%置信上限,樣品,

,1,66.90,2373.0,68.91,68.3,51.1,85.5,人體相關(guān)樣本1,

,2,167.83,2727.3,152.18,165.7,148.4,183.0,人體相關(guān)樣本2,

,3,30.68,7213.7,30.38,33.4,15.6,51.1,人體相關(guān)樣本3,

,4,69.41,2134.1,67.21,70.7,53.5,87.9,人體相關(guān)樣本4,

,5,200.54,7213.1,197.18,197.2,179.5,215.0,人體相關(guān)樣本5,

,6,52.29,4009.4,49.19,54.2,36.8,71.6,人體相關(guān)樣本6,

,7,67.90,2275.9,65.77,69.3,52.0,86.5,人體相關(guān)樣本7,

,8,194.68,6252.1,182.80,191.6,173.9,209.2,人體相關(guān)樣本8,

,9,93.22,501.2,92.26,93.7,76.7,110.7,人體相關(guān)樣本9,

,10,204.61,7921.6,187.55,201.2,183.3,219.0,人體相關(guān)樣本10,

,11,99.06,273.9,95.00,99.3,82.3,116.3,人體相關(guān)樣本11,

,12,183.55,4615.9,189.66,180.8,163.3,198.3,人體相關(guān)樣本12,

,13,195.75,6422.4,191.94,192.6,174.9,210.3,人體相關(guān)樣本13,

,14,111.52,16.7,124.96,111.3,94.4,128.3,人體相關(guān)樣本14,

,15,110.97,21.5,110.93,110.8,93.8,127.8,人體相關(guān)樣本15,

,16,102.00,185.3,95.83,102.2,85.2,119.2,人體相關(guān)樣本16,

,17,84.65,958.5,85.77,85.4,68.3,102.5,人體相關(guān)樣本17,

,18,145.14,872.2,157.57,143.8,126.7,160.9,人體相關(guān)樣本18,

,19,83.97,1000.9,86.48,84.8,67.7,101.9,人體相關(guān)樣本19,

,20,128.22,159.0,129.19,127.5,110.5,144.5,人體相關(guān)樣本20,

,21,102.75,165.3,108.81,102.9,85.9,119.9,人體相關(guān)樣本21,

,22,115.44,0.0,117.94,115.1,98.1,132.1,人體相關(guān)樣本22,

,23,34.60,6563.1,35.60,37.1,19.5,54.8,人體相關(guān)樣本23,

,24,141.88,690.1,149.18,140.6,123.6,157.7,人體相關(guān)樣本24,

,25,27.38,7783.9,27.55,30.2,12.4,48.0,人體相關(guān)樣本25,

,26,133.79,330.5,123.75,132.8,115.8,149.9,人體相關(guān)樣本26,

,27,129.54,194.0,126.20,128.7,111.7,145.7,人體相關(guān)樣本27,

,28,162.54,2202.7,168.85,160.6,143.3,177.8,人體相關(guān)樣本28,

,29,129.57,194.9,136.18,128.8,111.7,145.8,人體相關(guān)樣本29,

,30,97.89,313.9,103.92,98.2,81.2,115.2,人體相關(guān)樣本30,

,31,25.84,8059.2,25.75,28.7,10.8,46.5,校準(zhǔn)品水平1,

,32,38.61,5928.5,40.00,41.0,23.4,58.6,校準(zhǔn)品水平2,

,33,75.76,1588.0,80.96,76.8,59.7,94.0,校準(zhǔn)品水平3,

,34,126.92,127.9,121.68,126.2,109.2,143.2,校準(zhǔn)品水平4,

,34,164.37,2377.9,155.95,162.3,145.1,179.6,校準(zhǔn)品水平5,

,35,206.47,8255.0,208.93,202.9,185.1,220.8,校準(zhǔn)品水平6,

,,,,,,,,,,

產(chǎn)品校準(zhǔn)品的互換性計(jì)算,,,,,,,,,

"《GB/T21415-2008/ISO17511:2003體外診斷醫(yī)療器械生物樣品中量的測量校準(zhǔn)品和控制物質(zhì)賦值的計(jì)量學(xué)溯源性》要求：

國標(biāo)7.3：應(yīng)同時(shí)使用參考程序和經(jīng)校準(zhǔn)的常規(guī)程序測量準(zhǔn)備由常規(guī)測量程序測量的某類型的一組實(shí)際樣品，將結(jié)果比較，以證實(shí)制造商產(chǎn)品校準(zhǔn)品的互換性。

樣品應(yīng)是原始的、最好來自各個(gè)單一共同的、未添加任何物質(zhì)的人體樣品，它們的值應(yīng)盡可能分布于被測量特定的測量區(qū)間的整個(gè)范圍。

7.4：應(yīng)對(duì)每個(gè)樣品用參考和校準(zhǔn)的常規(guī)程序進(jìn)行重復(fù)測量。為達(dá)到計(jì)量學(xué)的溯源性，常規(guī)程序的結(jié)果應(yīng)與參考程序的結(jié)果相關(guān)，如一定概率下線性回歸的斜率為1，截距為0。

參考測量程序測量一組人體實(shí)際樣品的的結(jié)果x和常規(guī)測量程序測量一組人體實(shí)際樣品的結(jié)果y值如下：",,,,,,,,,

備注：圖中校準(zhǔn)品結(jié)果在95%置信限內(nèi)，兩種方法檢測工作校準(zhǔn)品的數(shù)學(xué)關(guān)系一致，工作校準(zhǔn)品的互換性滿足要求。,,,,,,,,,

序號(hào),自產(chǎn)試劑盒（多次測量xi）,,,自產(chǎn)平均,參考試劑盒（多次測量yi）,,,參考平均,備注

1,160.66,159.21,162.59,160.82,165.96,147.81,155.68,156.48,人體實(shí)際標(biāo)本

2,180.60,177.71,179.34,179.22,186.74,195.77,191.44,191.32,人體實(shí)際標(biāo)本

3,186.84,200.48,198.61,195.31,181.98,202.16,187.59,190.58,人體實(shí)際標(biāo)本

4,108.87,113.55,114.64,112.35,105.60,100.81,113.66,106.69,人體實(shí)際標(biāo)本

5,130.76,134.81,117.95,127.84,130.50,133.51,132.46,132.16,人體實(shí)際標(biāo)本

6,99.09,95.42,108.21,100.91,99.09,97.11,101.86,99.35,人體實(shí)際標(biāo)本

7,152.31,152.31,148.65,151.09,140.43,141.65,158.86,146.98,人體實(shí)際標(biāo)本

8,146.84,151.39,155.94,151.39,142.14,132.16,153.59,142.63,人體實(shí)際標(biāo)本

9,134.46,123.30,133.52,130.43,137.28,126.12,144.54,135.98,人體實(shí)際標(biāo)本

10,140.70,132.40,154.49,142.53,143.23,145.06,136.76,141.68,人體實(shí)際標(biāo)本

11,80.33,79.04,77.12,78.83,72.38,76.39,80.49,76.42,人體實(shí)際標(biāo)本

12,110.06,117.21,103.24,110.17,119.19,100.93,100.26,106.79,人體實(shí)際標(biāo)本

13,130.06,118.09,130.32,126.16,131.75,134.87,128.76,131.79,人體實(shí)際標(biāo)本

14,129.60,140.62,118.71,129.64,131.03,134.14,122.47,129.21,人體實(shí)際標(biāo)本

15,77.64,72.59,80.36,76.86,74.22,78.57,84.94,79.24,人體實(shí)際標(biāo)本

16,83.07,88.64,83.15,84.95,87.47,75.26,88.64,83.79,人體實(shí)際標(biāo)本

17,38.53,40.19,41.27,40.00,37.61,37.95,40.84,38.80,人體實(shí)際標(biāo)本

18,78.10,71.31,71.15,73.52,75.52,82.55,81.69,79.92,人體實(shí)際標(biāo)本

19,162.28,172.83,157.90,164.34,150.43,160.17,159.03,156.54,人體實(shí)際標(biāo)本

20,122.34,131.76,123.56,125.89,126.50,111.57,118.06,118.71,人體實(shí)際標(biāo)本

21,133.21,143.73,132.28,136.41,120.95,143.60,122.02,128.86,人體實(shí)際標(biāo)本

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