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1、2013年内分泌、肿瘤标志物、特定蛋白室间质量评价总结山西省临床检验质量控制中心 裴世静 马斌国一、 内分泌室间质量评价总结(一)、基本概况2013年,我省内分泌室间质量评价计划,参加实验室共计68个,较上年增长了83.8%,按时回报的实验室61个,回报率89.7%。全年完成质评计划一次,共5个批号的质评物(美国Bio-Rad)。质评项目13项:游离T3(FT3)、总T3(T3)、游离T4(FT4 )、总T4(T4)、促甲状腺素(TSH)、皮质醇(Cortisol)、雌二醇(E2)、促卵泡素(FSH)、黄体生成素(LH)、孕酮(P)、催乳素(PRL)、睾酮(T)、胰岛素(INS)。所有实验数据
2、按照检测系统不同进行分组统计,评价标准采用美国CLIA88能力验证计划的分析质量要求,评价方法为能力比对检验(PT)评价方法。全年两次PT得分均80%的实验室39个,合格率63.9%,其中两次PT得分均为100分的有11个,占到18.0%。(二)、结果汇总1. 参加实验室数据资料统计表1 原始数据资料统计项目样本编号实验室数平均数中位数标准差变异系数(%)最大值最小值游离T3201311565.83 5.76 1.37 23.50 10.51 2.71 2013125610.67 9.58 3.07 28.77 20.12 3.53 201313566.76 6.71 1.84 27.22 1
3、2.32 2.18 201314562.41 2.34 0.53 21.99 4.03 0.56 201315562.72 2.66 0.64 23.53 4.51 0.70 总T320131138441.39 1.98 2708.78 613.69 16700.00 1.18 20131238845.41 3.38 5190.54 613.97 32000.00 2.18 20131338486.94 2.24 2987.75 613.58 18420.00 1.24 20131438124.06 0.85 759.21 611.97 4681.00 0.30 20131538165.95
4、0.99 1016.80 612.71 6269.00 0.41 游离T42013115721.95 2.50 59.97 273.21 275.40 1.66 2013125743.88 5.06 120.39 274.36 561.50 2.89 2013135724.61 2.82 67.70 275.09 324.60 1.79 201314578.99 1.02 26.41 293.77 151.50 0.47 201315578.04 1.02 25.50 317.16153.10 0.51 总T42013113818.50 11.73 28.93 156.38 150.90 9.
5、22 2013123826.06 15.75 41.75 160.21 220.03 13.24 2013133819.90 12.58 30.89 155.23 163.12 9.54 201314389.90 5.79 15.33 154.85 74.45 4.60 201315389.74 5.98 15.11 155.13 74.28 4.60 TSH201311586.68 6.39 0.98 14.67 10.64 5.05 2013125837.25 37.04 7.01 18.82 49.58 4.23 201313586.43 6.30 1.20 18.66 10.01 1.
6、70 201314580.49 0.49 0.09 18.37 0.77 0.20 201315580.46 0.47 0.09 19.57 0.76 0.21 皮质醇201311820.37 21.28 2.77 13.60 23.90 15.93 201312836.95 38.26 5.34 14.45 45.20 29.70 201313820.23 20.01 3.18 15.72 24.00 15.68 20131483.66 3.61 0.63 17.21 4.80 2.72 20131582.92 2.84 0.49 16.78 3.90 2.24 雌二醇20131129588
7、 240 1847.85 314.26 10194 187 2013122915100 524 78465.27 519.64 423077 274 20131329917 268 3495.46 381.18 19090 193 20131429118 97 101.50 86.02 599 69 20131529114 101 82.08 72.00 523 72 FSH2013112927.7 27.6 2.74 9.89 33.1 22.4 2013122942.2 42.6 6.03 14.29 54.2 20.7 2013132926.8 26.2 3.12 11.64 32.8
8、20.2 2013142910.9 10.6 1.78 16.33 16.3 8.6 201315296.1 6.0 0.89 14.59 8.1 4.8 LH2013112921.06 20.28 7.71 36.61 58.57 15.75 2013122952.93 49.50 22.17 41.89 165.20 39.65 2013132921.62 20.54 8.95 41.40 65.40 11.65 201314291.63 1.32 1.26 77.30 8.02 0.94 201315291.70 1.50 0.90 52.94 6.11 0.89 孕酮201311281
9、0.35 9.70 4.05 39.13 29.04 4.83 2013122827.74 22.95 31.01 111.79 182.68 4.08 201313289.79 9.45 2.73 27.89 19.86 4.35 201314284.89 0.63 21.96 449.08 116.92 0.40 201315280.70 0.66 0.27 38.57 1.49 0.38 催乳素2013112868.02 21.70 169.23 248.79 841.07 14.22 20131228140.90 47.84 329.30 233.71 1586.87 27.75 20
10、13132860.86 19.58 141.29 232.16 657.78 12.77 2013142819.41 7.57 38.46 198.15 155.42 5.10 2013152817.57 7.5532.21 183.32 128.84 5.04 睾酮2013112770.8 19.7 144.59 204.22 500.0 2.8 20131227117.7 31.5 230.49 195.83 789.7 5.6 2013132771.3 19.9 145.44 203.98 487.0 2.5 2013142718.1 5.0 38.14 210.72 142.7 0.2
11、 2013152718.15.2 37.60 207.73 137.2 0.4 胰岛素20131135276 308 182.83 66.24 835 39 20131235921 1074 595.86 64.70 2985 134 20131335348 400 235.37 67.64 1100 52 2013143595 110 63.47 66.81 292 13 2013153590 99 62.05 68.94 279 13 表2 除外均数加减3倍标准差数据资料统计项目样本编号实验室数平均数中位数标准差变异系数(%)最大值最小值游离T3201311555.74 5.70 1.22
12、 21.25 9.40 2.71 2013125510.50 9.47 2.81 26.76 19.44 3.53 201313556.66 6.69 1.69 25.38 11.46 2.18 201314542.41 2.34 0.42 17.43 3.92 1.77 201315552.75 2.66 0.58 21.09 4.51 1.57 总T3201311371.97 1.97 0.31 15.74 2.84 1.18 201312373.39 3.37 0.57 16.81 4.87 2.18 201313372.26 2.21 0.40 17.70 3.48 1.24 2013
13、14370.90 0.84 0.52 57.78 3.78 0.30 201315371.00 0.99 0.34 34.00 2.62 0.41 游离T42013115512.99 2.49 37.36 287.61 199.68 1.66 2013125418.27 5.04 48.59 265.96 344.60 2.89 2013135410.15 2.77 26.90 265.02 190.12 1.79 201314554.61 1.02 12.13263.12 66.54 0.47 201315553.59 1.01 8.98 250.14 63.50 0.51 总T420131
14、13611.82 11.56 1.81 15.31 17.29 9.22 2013123616.43 15.63 2.38 14.49 22.77 13.24 2013133612.78 12.20 2.28 17.84 18.99 9.54 201314366.42 5.763.39 52.80 25.12 4.60 201315366.25 5.84 1.76 28.16 14.34 4.60 TSH201311576.61 6.39 0.84 12.71 8.90 5.05 2013125737.83 37.37 5.49 14.51 49.58 19.60 201313576.51 6
15、.30 1.03 15.82 10.01 4.25 201314560.49 0.49 0.07 14.29 0.64 0.30 201315570.46 0.46 0.08 17.39 0.65 0.21 皮质醇201311820.37 21.28 2.77 13.60 23.90 15.93 201312836.95 38.26 5.34 14.45 45.20 29.70 201313820.23 20.01 3.18 15.72 24.00 15.68 20131483.66 3.61 0.63 17.21 4.80 2.72 20131582.92 2.84 0.49 16.78 3
16、.90 2.24 雌二醇20131128245 240 37.46 15.29 367 187 20131228529 523 116.79 22.08 898 274 20131328267 266 38.02 14.24 342 193 20131428100 95 42.36 42.36 306 69 20131528100 99 24.17 24.17 203 72 FSH2013112927.7 27.6 2.74 9.89 33.1 22.4 2013122843.0 43.1 4.46 10.37 54.2 33.5 2013132926.8 26.2 3.12 11.64 32
17、.8 20.2 2013142810.7 10.6 1.47 13.74 14.3 8.6 201315296.1 6.0 0.89 14.59 8.1 4.8 LH2013112819.73 20.22 2.77 14.04 28.26 15.75 2013122848.92 49.41 5.14 10.51 57.31 39.65 2013132820.05 20.53 3.10 15.46 28.10 11.65 201314281.40 1.31 0.30 21.43 1.96 0.94 201315281.54 1.50 0.30 19.48 2.07 0.89 孕酮20131127
18、9.66 9.70 1.76 18.22 14.63 4.83 2013122722.00 22.76 6.40 29.09 41.08 4.08 201313279.42 9.39 1.93 20.49 15.36 4.35 201314270.75 0.60 0.29 38.67 1.38 0.40 201315280.70 0.66 0.27 38.57 1.49 0.38 催乳素2013112739.39 21.67 76.84 195.07 393.87 14.22 2013122787.35 46.61 170.92 195.67 883.38 27.75 2013132738.7
19、5 19.57 80.74 208.36 414.77 12.77 201314269.36 7.38 11.21 119.76 64.05 5.10 201315269.17 7.35 9.63 105.02 55.90 5.04 睾酮2013112770.8 19.7 144.59 204.22 500.0 2.8 20131227117.7 31.5 230.49 195.83 789.7 5.6 2013132771.3 19.9 145.44 203.98 487.0 2.5 2013142613.3 5.0 29.46 221.50 116.9 0.2 2013152613.5 5
20、.2 29.68 219.85 114.5 0.4胰岛素20131134259 295 157.10 60.66 687 39 20131234860 1061 482.56 56.11 1535 134 20131334326 387 198.56 60.91 819 52 2013143489 108 54.17 60.87 207 13 2013153485 98 53.44 62.87 232 13 2. 按检测系统分组统计结果表3 按系统分组统计数据项目批号组实验室数平均值中位数标准差变异系数(%)最大值最小值游离T3201311缺省组545.815.761.3423.1610.51
21、2.71Beckman135.215.020.8215.807.554.42Roche186.856.541.3019.0110.514.60Bayer35.695.700.183.175.865.50新产业33.282.820.9027.394.322.71201312缺省组5410.649.582.9928.1120.123.53Beckman139.589.231.6817.5713.947.80Roche1813.6712.982.6319.2220.128.44BAYER39.359.400.151.629.479.18新产业38.077.540.9211.389.137.54201
22、313缺省组546.736.711.8126.8712.322.18Beckman136.135.621.1618.859.094.96Roche188.167.751.5719.1812.325.34Bayer36.556.540.223.366.786.34新产业33.873.461.1329.135.153.01201314缺省组542.392.340.4920.634.030.56Beckman132.432.310.3715.353.462.12Roche182.542.400.5120.094.032.03Bayer32.492.530.135.402.602.34新产业31.99
23、1.840.2813.942.311.82201315缺省组542.702.660.6122.714.510.70Beckman132.732.590.4917.764.042.34Roche182.942.790.5719.274.512.39Bayer32.752.800.082.942.802.66新产业32.092.130.2210.462.281.85总T3201311缺省组37453.271.982745.14605.6216700.001.18Beckman91.981.880.3718.762.841.58Roche92.042.060.125.662.231.88Bayer2
24、2.212.210.010.642.222.20新产业22.082.080.178.162.201.96201312缺省组37868.163.375260.21605.9032000.002.18Beckman93.293.050.6820.704.872.56Roche93.523.430.298.244.083.17Bayer23.853.850.000.003.853.85新产业23.603.600.4712.963.933.27201313缺省组37500.042.263027.86605.5218420.001.24Beckman92.232.090.4922.163.481.73R
25、oche92.302.270.156.672.492.08Bayer22.542.540.051.952.572.50新产业22.042.040.4924.262.391.69201314缺省组37127.400.85769.40603.944681.000.30Beckman90.920.890.2627.951.550.68Roche90.880.860.067.051.010.83Bayer20.720.720.022.970.730.70新产业20.800.800.011.770.810.79201315缺省组37170.420.991030.45604.676269.000.41Be
26、ckman91.051.010.2928.071.780.79Roche91.021.030.065.591.120.92Bayer20.800.800.078.840.850.75新产业21.001.000.1817.771.120.87游离T4201311缺省组5522.232.4961.01274.49275.401.66Beckman1122.692.1059.30261.31199.681.76Roche1832.332.5673.25226.56261.502.41Bayer32.252.230.062.602.322.21新产业39.312.8311.96128.4523.111
27、.99201312缺省组5544.485.05122.48275.37561.502.89Beckman1140.074.04102.37255.48344.603.56Roche1868.085.63155.42228.29561.504.85Bayer34.364.340.081.884.454.29新产业321.125.6028.00132.5653.444.32201313缺省组5524.922.8068.88276.45324.601.79Beckman1122.332.3056.52253.08190.122.08Roche1837.402.9384.22225.19292.302
28、.67Bayer32.632.680.103.972.702.51新产业311.413.1514.90130.5828.612.47201314缺省组559.131.0226.87294.27151.500.47Beckman117.220.7818.20252.1861.230.64Roche1812.431.0328.39228.33107.700.97Bayer30.980.930.1010.291.100.92新产业34.211.195.55131.9010.610.82201315缺省组558.131.0125.95319.09153.100.51Beckman117.470.771
29、8.88252.7863.500.67Roche189.211.0424.98271.24107.701.01Bayer30.930.920.044.460.980.90新产业34.501.286.01133.4811.430.79总T4201311缺省组3718.7211.8529.29156.50150.909.22Beckman925.9310.5846.87180.74150.909.22Roche912.2111.852.3118.8917.299.26Bayer213.6013.600.000.0013.6013.60新产业611.4110.332.5322.1314.909.22
30、201312缺省组3726.3915.8542.28160.20220.0313.24Beckman937.8915.4368.31180.25220.0313.89Roche916.7415.882.8617.1022.7413.43Bayer218.4518.450.784.2219.0017.90新产业616.4615.563.3220.1522.7713.89201313缺省组3720.0912.4931.30155.76163.129.54Beckman927.6711.0650.80183.56163.129.54Roche913.0112.492.6019.9818.9910.2
31、0Bayer214.5314.530.392.6814.8014.25新产业612.0511.202.5421.1016.009.54201314缺省组3710.045.8115.52154.6774.454.60Beckman912.775.0523.13181.1274.454.73Roche96.266.061.3922.149.444.60Bayer25.935.930.254.186.105.75新产业66.105.141.8830.809.244.73201315缺省组379.876.0015.30155.0474.284.60Beckman912.825.0723.05179.7
32、274.284.73Roche96.276.081.3421.429.254.60Bayer26.106.100.142.326.206.00新产业66.195.241.8830.409.164.73TSH201311缺省组566.686.391.0014.9610.645.05Beckman136.126.070.518.407.545.58Roche197.047.150.476.687.696.00Bayer35.395.310.397.265.825.05新产业38.557.691.8221.2810.647.32201312缺省组5637.3437.557.1119.0549.584
33、.23Beckman1335.9534.902.777.7243.6033.05Roche1941.7442.703.207.6646.9836.00Bayer325.4635.6518.3972.2436.514.23新产业340.7540.968.9321.9249.5831.72201313缺省组566.436.301.2319.0610.011.70Beckman135.895.760.7813.287.544.25Roche196.596.921.2518.967.451.70Bayer35.465.400.274.955.765.23新产业38.698.401.2013.7710.
34、017.67201314缺省组560.490.490.0918.740.770.20Beckman130.450.450.0510.760.570.39Roche190.550.570.047.310.600.45Bayer30.390.390.0410.260.430.35新产业30.590.640.2135.510.770.36201315缺省组560.460.470.0919.510.760.21Beckman130.430.420.0510.570.540.38Roche190.520.530.047.650.570.41Bayer30.410.410.011.420.410.40新产
35、业30.620.650.1524.350.760.46皮质醇201311缺省组820.3721.282.7713.5923.9015.93201312缺省组836.9538.265.3414.4545.2029.70201313缺省组820.2320.013.1815.7424.0015.68201314缺省组83.663.610.6317.254.802.72201315缺省组82.922.840.4916.883.902.24雌二醇201311缺省组295882401847.85314.2210194187Roche1022822518.718.21257195Beckman4252261
36、29.1011.54276212Bayer324423915.536.38261231新产业325827141.4816.06292212201312缺省组27525521117.3022.33898274Roche1045745837.188.14524376201313缺省组2726626438.1314.32342193Roche1025325123.449.28289218201314缺省组271009243.1742.9930669Roche1097987.748.0210884201315缺省组271009724.5924.6920372Roche101031037.577.371
37、1591FSH201311缺省组2727.827.62.579.2233.123.0201312缺省组2742.942.64.5310.5554.233.5201313缺省组2727.026.22.8710.6632.822.1201314缺省组2711.110.91.7415.6616.38.6201315缺省组276.26.00.8513.588.14.8LH201311缺省组2720.8220.157.8737.8058.5715.75Roche1224.1220.6610.8945.1358.5720.15201312缺省组2753.2849.9322.9743.12165.2039.
38、65Roche1262.2952.2532.5252.21165.2049.10201313缺省组2721.4120.529.2042.9765.4011.65Roche1225.0621.2212.7550.8765.4020.00201314缺省组271.671.331.3078.238.021.04Roche122.171.751.8685.548.021.14201315缺省组271.741.510.9152.546.111.20Roche122.121.851.2860.146.111.29孕酮201311缺省组269.739.701.7517.9914.634.83Roche109
39、.559.700.646.6910.418.34201312缺省组2622.3322.956.3028.2041.084.08Roche1023.0823.482.018.6925.4818.60201313缺省组269.509.451.9220.2215.364.35Roche109.509.550.656.8810.408.19201314缺省组265.190.6022.79439.12116.920.40Roche100.490.480.0612.770.600.40201315缺省组260.660.610.2335.071.110.38Roche100.460.460.0511.580.530.38催乳素201311缺省组2657.5321.70162.65282.71841.0714.22Roche1022.7622.461.034.5324.8521.73201312缺省组26116.7047.84306.50262.641586.8731.58Roche1053.5853.273.496.5160.3849.56201313缺省组
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