免疫定性分析性能驗證報告(cut off)

1、第 #頁，共8頁第 頁，共8頁廣東省中醫(yī)院二沙島分院檢驗科ELISA法檢測乙肝五項、丙肝試劑盒CUTOFF值驗證報告一、HBsAg1、目的：驗證本實驗室HBsAgELISA試劑盒的CUTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、方法：選擇60份健康人新鮮血清和60份HBsAg陰性而有其他免疫標志物陽性的患者新鮮血清，共120份，分三批進行檢測，計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X+3SD并與CUTOFF值進行比較，若小于CUTOFF發(fā)光值則CUTOFF值驗證通過，反之則不通過。3、室驗數(shù)據(jù)：標本號0D值標本號0D值標本號0D值標本號0D值10.030310.0316

2、10.029910.05720.028320.030620.034920.05030.031330.027630.025930.04640.067340.028640.023940.02450.023350.032650.054950.03160.030360.038660.041960.02870.028370.026670.078970.02680.032380.036680.085980.04090.030390.032690.061990.034100.031400.032700.0281000.026110.027410.042710.0581010.028120.025420.03

3、5720.0581020.034130.028430.053730.0431030.034140.033440.025740.0551040.030150.032450.043750.0481050.032160.031460.035760.0571060.026170.031470.033770.0801070.031180.027480.026780.0411080.027190.030490.037790.0441090.028200.027500.028800.0451100.031210.027510.031810.0631110.029220.028520.026820.04011

4、20.028230.029530.036830.0431130.031240.026540.033840.0491140.028170.025470.048770.0261070.041180.027480.023780.1041080.056190.021490.029790.0221090.062200.018500.020800.0311100.020210.015510.019810.0141110.019220.025520.018820.0191120.014170.025470.048770.0261070.041180.027480.023780.1041080.056190.

5、021490.029790.0221090.062200.018500.020800.0311100.020210.015510.019810.0141110.019220.025520.018820.0191120.014250.030550.024850.0751150.030260.030560.031860.0521160.027270.026570.029870.0901170.030280.028580.032880.0451180.024290.028590.078890.0531190.037300.028600.022900.0581200.032第 頁，共8頁第 頁，共8頁

6、第2頁,共8頁4、結(jié)果：X+3SD=0.037+0.014*3=0.079,試劑盒CUTOF值為0.105,故X+3SD值小于CUTOFF值。5、結(jié)論：本實驗室HBsAgELISA試劑盒所選擇的CUTOFF值適用于本實驗室所屬區(qū)域內(nèi)的99%正常人群。二、HBsAb1、目的：驗證本實驗室HBsAbELISA試劑盒的CUTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、方法：選擇60份HBsAb陰性新鮮血清和60份HBsAb陰性而有其他免疫標志物陽性的患者新鮮血清,共120份,分三批進行檢測,計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X+3SD并與CUTOFF值進行比較,若小于CUT

7、OFF發(fā)光值則CUTOFF值驗證通過，反之則不通過。3、室驗數(shù)據(jù)：標本號123456789101112131415160D值0.0190.0220.0160.0770.0410.0350.0670.0160.0140.0210.0180.0140.0120.0460.0880.037標本號31323334353637383940414243444546OD值0.0140.0130.0390.0100.0900.0110.0500.0160.0320.1000.0130.0690.0130.0160.0130.023標本號61626364656667686970717273747576OD值0.

8、0630.0370.0150.0790.0260.0330.0260.0190.0200.0190.0170.0260.0150.0360.0230.080標本號0D值0.0090.0780.0030.0030.0020.0180.0150.0930.0210.0170.0870.0530.0200.0160.0500.053230.066530.020830.0121130.016240.100540.016840.0111140.025250.011550.017850.0511150.044260.016560.032860.0631160.016270.011570.015870.02

9、71170.021280.015580.063880.0061180.016290.012590.037890.0481190.017300.054600.015900.0071200.0164、結(jié)果：X+3SD=0.031+0.024*3=0.103,試劑盒CUTOF值為0.105,故X+3SD值小于CUTOFF值。5、結(jié)論：本實驗室HBsAbELISA試劑盒所選擇的CUTOFF值適用于本實驗室所屬區(qū)域內(nèi)的99%正常人群。三、HBeAg1、目的：驗證本實驗室HBeAgELISA試劑盒的CUTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、方法：選擇60份健康人新鮮血清和60份HBeAg陰

10、性而有其他免疫標志物陽性的患者新鮮血清,共120份,分三批進行檢測,計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X+3SD并與CUTOFF值進行比較，若小于CUTOFF發(fā)光值則CUTOFF值驗證通過，反之則不通過。3、室驗數(shù)據(jù)：標本號1234560D值0.0110.0090.0130.0110.0100.012標本號313233343536OD值0.0260.0150.0190.0110.0090.013標本號616263646566OD值0.0120.0140.0080.0260.0150.019標本號0D值0.0130.0110.0100.0120.0180.01670.01437

11、0.011670.011970.01770.014370.011670.011970.017第 #頁,共8頁第 頁,共8頁80.008380.010680.009980.02190.029390.012690.013990.021100.007400.014700.0111000.011110.02410.008710.0101010.009120.011420.026720.0121020.013130.009430.015730.0181030.011140.013440.019740.0161040.010150.011450.011750.0171050.012160.01460.00

12、9760.0151060.018170.012470.013770.0261070.016180.014480.011780.0111080.017190.008490.010790.0091090.021200.029500.012800.0131100.021210.007510.018810.0111110.011220.020520.016820.0101120.011230.011530.017830.0121130.009240.009540.015840.0181140.010250.013550.026850.0161150.010260.011560.011860.01711

13、60.012270.01570.009870.0211170.012280.012580.013880.0111180.014290.014590.011890.0111190.016300.008600.010900.0091200.0114、結(jié)果：X+3SD=0.014+0.005*3=0.029,試劑盒CUTOF值為0.105,故X+3SD值小于CUTOFF值。5、結(jié)論：本實驗室HBeAgELISA試劑盒所選擇的CUTOFF值適用于本實驗室所屬區(qū)域內(nèi)的99%正常人群。四、HBeAb1、目的：驗證本實驗室HBeAbELISA試劑盒的CUTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、

14、方法：選擇60份HBeAb陰性新鮮血清和60份HBeAb陰性而有其他免疫標志物陽性的患者新鮮血清,共120份,分三批進行檢測,計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X-3SD并與CUTOFF值進行比較,若大于CUTOFF發(fā)光值則CUTOFF值驗證通過，反之則不通過。第6頁，共8頁第6頁，共8頁第 頁,共8頁3、室驗數(shù)據(jù)：標本號0D值標本號0D值標本號0D值標本號0D值11.479312.240611.025912.48422.374322.462622.537922.52832.511331.976632.591932.43841.780342.570642.543942.655

15、52.361352.310651.264951.86462.491362.526662.451962.49072.516372.526672.398972.28682.446382.555682.563982.36092.551391.913692.457992.435102.615402.423702.2281002.435112.628412.422711.0851012.331122.49421.920722.5611022.218132.199432.533732.6021032.286142.320441.170742.6501042.331152.203451.750751.781

16、1052.306162.246462.151762.5201062.012172.184471.468772.3941072.044182.280482.638782.4661082.383192.221492.620792.5631092.045202.201502.626801.5581102.337212.255512.388812.4141112.334222.43522.572822.3951121.396232.447532.632832.3071132.244242.439542.227842.2821141.314252.575552.209852.2611152.245262

17、.339562.402861.1631162.224271.017572.491871.9881172.205282.439582.468882.3081182.383291.452592.190892.2491191.496302.030602.179902.5161202.5154、結(jié)果：X-3SD=2.240-0.386*3=1.082,試劑盒CUTOF值為1.021,故X3SD值大于CUTOFF值。5、結(jié)論：本實驗室HBeAbELISA試劑盒所選擇的CUTOFF值適用于本實驗室所屬區(qū)域內(nèi)的99%正常人群。五、HBcAb-IgG1、目的：驗證本實驗室HBcAb-IgGELISA試劑盒的C

18、UTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、方法：選擇60份HBcAb-IgG陰性新鮮血清和60份HBcAb-IgG陰性而有其他免疫標志物陽性的患者新鮮血清，共120份，分三批進行檢測，計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X-3SD并與CUTOFF值進行比較，若大于CUTOFF發(fā)光值則CUTOFF值驗證通過，反之則不通過。3、室驗數(shù)據(jù)：標本號0D值標本號0D值標本號0D值標本號0D值12.076312.489611.992911.81722.314322.454621.530922.01132.073332.300632.003931.87341.557342.17

19、4641.642941.71852.201352.100651.948951.12761.909362.476662.066961.59171.980371.685671.811971.75781.932381.771681.993981.73891.711391.634691.834992.031101.902402.213702.0611001.770112.054412.055711.8801011.641122.118422.158721.8921021.912131.965432.21731.8461031.600141.856442.329741.9841041.740151.95

20、1452.061751.9511051.839161.974462.122761.6151061.014171.908471.714771.4201071.156182.055481.369781.7181081.414192.054492.111792.0091091.469201.579501.990801.5931101.781211.826512.103811.9141111.799221.905522.028822.1401121.715231.526532.019831.5701131.238241.825542.188841.7661142.173252.359551.84485

21、1.8741151.284262.532561.108862.0191162.137272.438572.035871.9331171.622282.440581.798881.8641181.621291.786592.135892.0451191.758第8頁,共 頁210.027第7頁，共8頁301.542601.952902.0151201.8594、結(jié)果：X-3SD=1.884-0.294*3=1.002,試劑盒CUTOF值為0.938,故X-3SD值大于CUTOFF值。5、結(jié)論：本實驗室HBcAb-IgGELISA試劑盒所選擇的CUTOFF值適用于本實驗室所屬區(qū)域內(nèi)的99%正常人群。六、HCV-IgG1、目的：驗證本實驗室HCV-IgGELISA試劑盒的CUTOFF值是否適用于本實驗室所屬區(qū)域內(nèi)的個體人群。2、方法：選擇60份健康人新鮮血清和60份HCV-IgG陰性而有其他免疫標志物陽性的患者新鮮血清,共120份,分三批進行檢測,計算所有標本檢測結(jié)果OD值的均值X和標準差SD,計算X+3SD并與CUTOFF值進行比較，若小于CUTOFF發(fā)光值則CUTO