2016特殊蛋白第一次室間質量評價結果報告四川省臨床檢驗中心二O一六年五月組織機構：四川省臨床檢驗中心

能力驗證負責人：黃文芳

聯系人：王為聯系地址：成都市一環路西二段32號郵政編碼：610072聯系電話：（028）87394057

傳真：（028）87394057實施機構：四川省臨床檢驗中心技術負責人：袁紅蔣黎技術專家：劉華、杜瓊、王智斌、袁紅、喻華、林嘉、傳良敏、李目錄一、前言二、本次質評的特點1、質評的目的和意義2、參加實驗室的范圍（分布）

3、質評測試項目和要求4、樣本情況描述5、保密性要求6、日程安排三、評價原則四、統計處理結果及結果評價

五、技術分析和建議附錄A特殊蛋白檢測室間質量評價樣本均勻性、穩定性檢驗技術報告

A.1樣本均勻性評價報告A.2樣本穩定性評價報告附錄B、相關文件B1、年四川省特殊蛋白室間質量評價活動安排及注意事項一、前言本報告是對2016果的總結，由四川省臨床檢驗中心（SPCCL）負責起草，中心主任審核并批

準發布。2016第一次《特殊蛋白》室間質量評價計劃由SPCCL組織及實施。二、本次質評的特點1、目的和意義四川省特殊蛋白室間質量評價計劃，是保證各臨床實驗室檢測質量的重

要手段。可以評價參評實驗室檢測IgG、IgA、IgM、IgE、C3、C4、CRP（C反

白蛋白的能力；發現在檢測中存在的共性問題以及某些實驗室存在的特殊問

題，促進實驗室提高檢測水平。2、參加實驗室的范圍本次能力驗證共有來自21134個實驗室參加。每個參試實驗室

進行唯一性編碼，在報告中只出現實驗室代碼，從而對參試實驗室的有關技

年度共有家實驗室報名參加本年度年腫瘤標志物室間質

評活動。本次有個實驗室回報了結果，家實驗室未按時回報結果。

3、檢測項目和要求3.1要求實驗室使用日常檢測所用方法：透射比濁法、散射比濁法、時間分辨熒光免疫試驗(TR-FIA)、化學發光免疫試驗(CIA)。3.2臨床檢驗中心免疫學室間質量評價活動安排及注意事項”。附件內容見附錄B。3.3檢測結果等相關信息參加用戶通過訪問四川省臨檢中心網

（/）通過用戶名和密碼進入室間質量評價界面，在相應

“特殊蛋白檢測結果”網絡提交，然后在“已上報”欄進行確認。4、樣本情況描述4.1本次室間質量評價使用的待測樣本，購買的公司產品。樣品特性：液體。4.2均勻性和穩定性檢驗均勻性要求每種含量隨機抽取支樣本，用實驗室常規試劑檢測，各含量

質控物的瓶間差異小于方法學變異；穩定性要求樣本在室溫可穩定至少天。

5、保密性要求每個參加實驗室被隨機分配一個唯一代碼，為保證給參加實驗室檢測的結

果保密，本報告中每個參加實驗室均以代碼表示。6、計劃日程安排2016年第一次四川省特殊蛋白室間質量評價共支樣本，于月郵寄，每支樣本檢測11個項目，檢測項目包括IgG、IgA、IgM、IgE、C3、C4、CRP（C前白蛋白。具體安排見表。表1年四川省臨床檢驗中心免疫學室間質量評價活動安排活動次數批號樣本建議結果上報質評成績測定日期截止日期下發日期161116121613161416152016年427日2016年510日年5月日三、評價原則本次室間質量評價共檢測C4、CRP（C反應蛋白）、RF（類風濕因子）、ASO（抗鏈球菌溶血素O）、TRF

（轉鐵蛋白）、前白蛋白。對于定量測定室間質量評價主要是看參評實驗室對質評樣本的測定結果

與靶值的偏差程度，根據符合率來判斷參評實驗室的能力是否合格（合格標準為大于等于80%樣本數某項目樣本總數）×100＝本次某項目測定得分，如果該項目得分大于

等于80%樣本數樣本總數）×100＝本次所有項目測定得分,如果所有項目得分大于等

于80%則為合格。未按時回報結果者判為不合格，該次得分為四、統計處理結果及結果評價1.特殊蛋白項目匯總統計結果，見表。2特殊蛋白匯總統計結果實項目樣本編號驗室數平均數中位數標準差變異系數(%)最大值最小值IgG16111037.127.160.567.878.545.29161210218.3218.21.659.0124.6514.05161310313.212.525.0438.1859.868.6416141037.467.50.68.048.765.55161510313.0712.594.9838.160.28.54IgA16111031.061.050.19.431.320.7916121033.643.650.339.075.132.7116131032.582.50.415.53.761.8616141031.231.220.18.131.490.9616151032.582.530.415.541.8IgM16111030.560.540.0814.290.960.316121032.082.060.2210.583.11.5816131031.371.320.2618.982.80.9416141030.680.620.6189.716.80.416151031.371.320.2618.982.160.7C31611970.780.770.067.690.950.641612972.382.390.156.32.721.881613971.751.70.2313.142.631.31614970.870.870.066.91.080.751615971.741.710.2514.372.511.15C41611960.150.150.016.670.180.121612960.520.510.059.620.640.431613960.380.360.1642.111.860.221614960.180.180.0211.110.210.141615960.370.360.0821.620.990.25CRP16111066.186.051.4924.1112.5517846.29.3319.9493.114526.96.4523.552.121.1816141065.555.461.4325.7711.221.19161510627.2227.096.2723.0353.211.1ASO161111278.38016.6821.316411612112199.2207.537.0618.6305.91111613112134.9137.129.8622.1321616161411275.276.115.8921.13153.811615112263.61341380.5523.71473914RF16111132222.54.9922.6847.210.4161211340.139.89.6624.097918.3161311330.6318.126.4764.83.3161411320.320.64.5722.5142.99.6161511330.730.38.0926.3559.815.5IgE1611224647.46.8514.8954.624.9161222154.215521.2813.8192.490.4161322120.8115.436.930.55208.558.916142158.1597.2512.487644.1161521131.512816.9812.91170106轉鐵蛋白1611142.111.472.53119.9110.91.251612143.963.541.6341.169.63.231613142.962.282.4783.4511.431.931614142.291.622.56111.7911.171.421615142.942.352.481.6311.271.99前白蛋白161161135.4136.510.948.08163114161261326.432528.748.81414264161361223.922431.7114.16326168161461151151.612.18.01182125.6161561219.322031.1614.21309146特殊蛋白不同試劑匯總統計結果，見表。表3.特殊蛋白不同試劑檢測統計結果（原始數據）項目樣本編號試劑實驗中位數變異系數(%)室數所有試劑1037.127.160.567.878.545.29Abbott17.58Beckman147.307.360.456.168.026.17107.207.200.537.368.026.0046.876.860.202.917.126.65上海科華36.707.230.9914.787.305.56四川邁克277.387.400.344.618.156.50北京利德曼46.896.780.537.697.586.42DiaSys96.966.830.426.037.886.53寧波瑞源生物科技有限公司15.29深圳國賽17.40其它（請詳述）286.997.010.639.018.545.991612所有試劑10218.3218.201.659.0124.6514.05Abbott120.76Beckman1419.1618.981.407.3122.3017.131018.1018.451.216.6919.5016.00417.7317.770.221.2417.9417.42上海科華318.2519.4317.0420.6014.72四川邁克2718.5818.001.8610.0124.6516.20北京利德曼417.4417.911.448.2618.5815.35DiaSys918.4418.510.744.0119.2917.07寧波瑞源生物科技有限公司114.05深圳國賽118.15其它（請詳述）2717.9918.031.689.3422.0114.381613所有試劑10313.2012.525.0438.1859.868.64Abbott113.30Beckman1412.6712.162.1817.2119.0310.801012.8012.651.7613.7515.4010.00412.7012.151.3310.4714.67上海科華310.982.0618.7612.508.64四川邁克2713.0212.811.8514.2118.739.84北京利德曼412.2812.450.463.7512.62DiaSys910.861.5313.1813.689.59寧波瑞源生物科技有限公司112.50深圳國賽114.20其它（請詳述）2812.1012.251.159.5013.889.571614所有試劑1037.467.500.608.048.765.55Abbott17.91Beckman147.817.810.567.178.536.67107.467.620.719.528.766.0047.087.120.141.987.216.88上海科華37.097.600.9813.827.705.96四川邁克277.677.690.344.438.347.00北京利德曼47.247.020.828.366.55DiaSys97.290.466.318.386.80寧波瑞源生物科技有限公司15.55深圳國賽17.18其它（請詳述）287.347.260.628.458.746.101615所有試劑10313.0712.594.9838.1060.208.54Abbott113.53Beckman1413.061.5615.7010.201012.2912.240.816.5913.3010.60412.100.635.3112.3010.92上海科華31.4413.0312.359.51四川邁克2712.4112.361.4116.268.54北京利德曼412.4912.230.917.2913.73DiaSys912.8412.692.0115.6515.579.26寧波瑞源生物科技有限公司110.35深圳國賽110.17其它（請詳述）2812.2212.201.4614.508.80所有試劑1031.061.050.109.431.320.79Abbott1Beckman141.011.000.054.950.91101.131.150.097.961.320.9941.041.020.043.851.101.02上海科華31.151.150.021.741.171.13四川邁克271.051.070.109.521.210.79北京利德曼41.091.070.098.261.201.00DiaSys91.041.030.054.811.130.98寧波瑞源生物科技有限公司10.92深圳國賽11.03其它（請詳述）281.051.050.121.310.811612所有試劑1033.643.650.339.075.132.71Abbott13.79Beckman143.833.840.164.184.123.48103.923.950.266.634.443.4243.453.430.144.063.633.29上海科華33.583.610.092.513.643.48四川邁克273.483.520.329.203.892.71北京利德曼43.773.740.246.374.083.54DiaSys93.633.640.123.313.863.48寧波瑞源生物科技有限公司13.48深圳國賽13.95其它（請詳述）283.603.570.405.132.981613所有試劑1032.582.500.4015.503.761.86Abbott12.56Beckman142.532.300.5220.553.582.08102.822.780.3913.833.392.2042.552.450.302.992.32上海科華32.442.480.083.282.492.35四川邁克272.512.500.3212.753.411.98北京利德曼42.642.600.197.202.882.48DiaSys92.382.390.2912.182.812.04寧波瑞源生物科技有限公司12.95深圳國賽13.29其它（請詳述）282.472.460.2510.123.061.861614所有試劑1031.231.220.108.131.490.96Abbott11.31Beckman141.181.190.075.931.361.08101.331.320.107.521.491.1741.201.190.021.671.221.18上海科華31.291.300.064.651.351.23四川邁克271.231.240.108.131.430.96北京利德曼41.251.240.108.001.381.15DiaSys91.201.200.054.171.281.13寧波瑞源生物科技有限公司11.07深圳國賽11.24其它（請詳述）281.231.238.941.471.02

1615所有試劑1032.582.530.4015.504.001.80

Abbott12.62Beckman142.602.650.313.372.17

102.682.740.238.582.972.25

42.372.400.145.912.502.17

上海科華32.532.540.166.322.682.36

四川邁克272.432.470.273.312.00

北京利德曼42.612.570.4416.863.192.12

DiaSys92.632.510.4717.873.271.84寧波瑞源生物科12.35技有限公司深圳國賽12.17其它（請詳述）282.532.440.4216.603.441.80所有試劑1030.560.540.0814.290.960.30Abbott10.51Beckman140.600.610.046.670.690.52100.580.580.035.170.640.5340.520.520.023.850.550.51上海科華30.810.900.2024.690.960.58四川邁克260.520.520.047.690.600.42北京利德曼40.540.540.035.560.590.51DiaSys90.550.540.035.450.600.50寧波瑞源生物科技有限公司10.53深圳國賽10.59其它（請詳述）290.540.540.0916.670.760.301612所有試劑1032.082.060.2210.583.101.58Abbott11.97Beckman142.192.200.177.762.511.84102.102.135.242.241.9341.951.940.073.592.041.88上海科華32.773.010.4917.693.102.21四川邁克262.002.030.136.502.191.63北京利德曼42.032.030.146.902.211.86DiaSys92.082.050.083.852.221.99寧波瑞源生物科技有限公司12.08深圳國賽12.17其它（請詳述）292.072.080.2210.632.771.581613所有試劑1031.371.320.2618.982.800.94Abbott11.26Beckman141.381.330.2316.671.931.02101.391.330.161.691.2241.361.260.2216.181.691.22上海科華31.571.330.4428.032.071.30四川邁克261.321.300.151.751.02北京利德曼41.341.398.211.401.18DiaSys91.231.220.1713.821.481.02寧波瑞源生物科技有限公司11.60深圳國賽11.66其它（請詳述）291.301.310.1914.621.710.941614所有試劑1030.680.620.6189.716.800.40Abbott10.59Beckman141.100.681.64149.096.800.58100.640.640.046.250.700.5640.590.580.023.390.620.57上海科華30.901.010.2325.561.060.64四川邁克260.590.600.058.470.700.44北京利德曼40.610.620.023.280.630.58DiaSys90.610.610.046.560.670.55寧波瑞源生物科技有限公司10.60深圳國賽10.68其它（請詳述）290.620.620.0914.520.860.401615所有試劑1031.371.320.2618.982.160.70Abbott11.30Beckman141.481.470.1812.161.901.15101.381.417.971.501.1641.261.280.097.141.341.13上海科華31.881.980.3217.022.131.52四川邁克261.241.270.1612.901.630.77北京利德曼41.321.380.1914.391.471.05DiaSys91.401.280.2517.861.801.06寧波瑞源生物科技有限公司11.27深圳國賽11.14其它（請詳述）291.341.280.2518.661.830.70所有試劑970.780.770.067.690.950.64Abbott10.77Beckman140.720.730.045.560.780.6490.820.830.067.320.910.7240.790.790.011.270.800.79上海科華20.850.850.055.880.880.81四川邁克240.780.790.045.130.880.71北京利德曼50.750.730.068.000.860.70DiaSys90.780.780.045.130.830.72寧波瑞源生物科技有限公司10.72深圳國賽10.76其它（請詳述）270.790.760.067.590.950.701612所有試劑972.382.390.156.302.721.88Abbott12.45Beckman142.352.400.208.512.621.88

92.482.510.135.242.642.28

42.522.574.372.602.36

上海科華22.632.630.083.042.682.57

四川邁克242.292.280.104.372.452.10

北京利德曼52.452.460.187.352.722.24

DiaSys92.382.370.062.522.482.30

寧波瑞源生物科12.47技有限公司深圳國賽12.49其它（請詳述）272.402.430.125.002.642.141613所有試劑971.751.700.2313.142.631.30Abbott11.74Beckman141.711.690.2313.452.151.3991.781.740.212.211.5041.841.780.158.152.061.74上海科華21.691.690.010.591.701.68四川邁克241.721.680.1810.472.261.41北京利德曼51.821.820.2815.382.261.55DiaSys91.571.560.2113.381.891.30寧波瑞源生物科技有限公司12.09深圳國賽12.04其它（請詳述）271.701.700.169.412.061.351614所有試劑970.870.870.066.901.080.75Abbott10.88Beckman140.830.840.056.020.900.7590.920.910.066.520.980.8340.870.880.033.450.890.83上海科華20.950.950.066.320.990.91四川邁克240.870.870.055.750.970.79北京利德曼50.840.810.067.140.940.80DiaSys90.870.890.044.600.910.79寧波瑞源生物科技有限公司10.81深圳國賽10.88其它（請詳述）270.880.870.077.951.080.801615所有試劑971.741.710.2514.372.511.15Abbott11.77Beckman141.751.740.1910.862.061.4391.801.821.911.5641.671.700.127.191.771.52上海科華21.891.890.136.881.981.80四川邁克241.641.640.169.762.181.31北京利德曼51.721.700.2816.282.141.37DiaSys91.741.660.3218.392.161.17寧波瑞源生物科技有限公司11.66深圳國賽11.42其它（請詳述）271.701.710.2414.122.101.15所有試劑960.150.150.016.670.180.12Abbott10.15Beckman140.160.160.016.250.170.1590.160.160.016.250.180.1540.140.140.017.140.140.13上海科華20.140.140.017.140.140.13四川邁克240.150.150.016.670.170.12北京利德曼50.140.150.0214.290.150.12DiaSys90.140.140.017.140.160.13寧波瑞源生物科技有限公司10.14深圳國賽10.15其它（請詳述）260.150.150.016.670.160.121612所有試劑960.520.510.059.620.640.43Abbott10.52Beckman140.580.590.046.900.640.5090.540.540.035.560.580.4940.510.510.011.960.520.49上海科華20.500.500.012.000.500.49四川邁克240.490.490.036.120.560.43北京利德曼50.500.490.024.000.520.47DiaSys90.490.480.036.120.540.44寧波瑞源生物科技有限公司10.51深圳國賽10.61其它（請詳述）260.520.520.059.620.640.441613所有試劑960.380.360.161.860.22Abbott10.36Beckman140.380.390.0718.420.510.2290.370.370.0410.810.450.3240.360.340.0513.890.430.33上海科華20.340.340.025.880.350.32四川邁克240.350.360.040.470.29北京利德曼50.350.350.038.570.400.31DiaSys90.320.310.0515.630.420.25寧波瑞源生物科技有限公司10.43深圳國賽10.47其它（請詳述）260.360.360.040.430.281614所有試劑960.180.180.020.210.14Abbott10.18Beckman140.190.190.015.260.210.1890.190.190.015.260.210.1740.160.160.016.250.170.16上海科華20.170.170.015.880.170.16四川邁克240.180.180.015.560.200.14北京利德曼50.170.170.020.180.15DiaSys90.170.170.015.880.190.16寧波瑞源生物科技有限公司10.17深圳國賽10.20其它（請詳述）260.180.180.020.200.141615所有試劑960.370.360.0821.620.990.25Abbott10.36Beckman140.450.410.1635.560.990.3390.370.380.030.410.3140.330.340.026.060.350.31上海科華20.360.360.025.560.370.34四川邁克240.340.340.038.820.450.29北京利德曼50.330.320.0515.150.400.26DiaSys90.360.360.0513.890.430.26寧波瑞源生物科技有限公司10.35深圳國賽10.34其它（請詳述）260.360.360.0616.670.480.25所有試劑1066.186.051.4912.551.13Abbott26.306.300.142.226.406.20Beckman107.817.920.719.099.236.9855.995.930.284.676.405.65OrionDiagnostica46.516.100.8813.527.826.0055.975.980.122.016.105.80北京東雅科美15.50上海科華35.102.7453.737.202.00四川邁克165.765.921.2722.057.504.00北京利德曼47.797.501.4819.009.806.35DiaSys106.456.210.9414.578.005.30寧波瑞源生物科技有限公司28.208.206.1575.0012.553.85深圳國賽26.436.430.8613.377.035.82其它（請詳述）405.765.941.3323.098.661.131612所有試劑10646.7846.209.3319.9493.101.14Abbott248.9048.902.555.2150.7047.10Beckman1051.8451.804.468.6057.2044.00542.1041.501.603.8044.6040.60OrionDiagnostica451.4250.204.298.3457.2648.00545.1244.501.132.5046.9044.15北京東雅科美146.00上海科華349.0852.7014.5229.5861.4533.10四川邁克1647.2847.606.5852.7042.00北京利德曼452.6352.258.0915.3760.5045.50DiaSys1044.9743.676.6914.8858.0031.80寧波瑞源生物科技有限公司267.9367.9335.6052.4193.1042.75深圳國賽244.0544.0510.5123.8651.4836.61其它（請詳述）4044.5546.1010.7324.0969.391.141613所有試劑10627.4526.906.4523.5052.121.18Abbott224.7524.752.7626.7022.80Beckman1025.9824.055.0419.4037.3321.50525.3823.902.8930.0023.00OrionDiagnostica428.4329.574.6416.3232.6022.00526.2126.421.485.6528.0523.96北京東雅科美126.60上海科華324.6327.0046.4534.7012.20四川邁克1628.7128.503.6412.6834.7821.40北京利德曼430.0028.104.5915.3036.8027.00DiaSys1027.0426.105.6921.0441.0021.05寧波瑞源生物科技有限公司240.6140.6116.2840.0952.1229.10深圳國賽227.7527.756.0121.6632.0023.50其它（請詳述）4025.8926.596.2224.0239.911.181614所有試劑1065.555.461.4325.771.19Abbott25.605.600.142.505.705.50Beckman106.776.730.659.608.025.8555.475.460.175.705.25OrionDiagnostica46.296.200.375.886.766.0055.545.430.325.786.105.35北京東雅科美14.70上海科華34.084.951.8144.365.302.00四川邁克165.015.251.2725.356.803.00北京利德曼46.966.531.5321.989.105.70DiaSys105.805.730.8214.147.004.70寧波瑞源生物科技有限公司27.267.265.6077.133.30深圳國賽25.485.480.529.495.85其它（請詳述）405.285.341.4828.0310.521.191615所有試劑10627.2227.096.2723.0353.211.10Abbott225.6525.652.6210.2127.5023.80Beckman1026.6427.553.8914.6033.6020.50523.6223.701.426.0125.8022.00OrionDiagnostica427.5926.504.8517.5834.3423.00526.0225.941.385.3028.1024.21北京東雅科美127.70上海科華323.6628.7015.0963.7835.586.70四川邁克1626.772.509.2233.1321.00北京利德曼430.6527.706.3820.8240.2027.00DiaSys1027.3627.124.5016.4534.6021.35寧波瑞源生物科技有限公司238.0138.0121.5056.5653.2122.80深圳國賽223.8923.895.0721.2227.4720.30其它（請詳述）4026.3626.726.3123.9436.431.10所有試劑78.380.016.6821.30164.01.0Abbott170.0Beckman1058.759.23.546.0362.750.7794.697.910.94103.071.1681.582.04.465.4788.076.0上海長征160.0北京東雅科美150.1上海科華682.684.014.1096.865.4四川邁克1367.971.121.1831.1993.01.0北京利德曼580.481.04.195.2185.073.6DiaSys1488.387.25.015.6797.480.9寧波瑞源生物科技有限公司282.282.21.842.2483.580.9深圳國賽161.2其它（請詳述）4480.379.717.4521.73164.052.01612所有試劑199.2207.537.0618.60305.9Abbott1164.0Beckman10123.8122.09.007.27137.07221.9223.022.3710.08245.0176.06213.78.584.05221.0198.0上海長征1151.0北京東雅科美1155.8上海科華6203.8209.924.29225.0161.3四川邁克13199.1202.028.5014.31238.0北京利德曼5208.0205.010.314.96223.0195.1DiaSys14227.7222.616.657.31270.1209.4寧波瑞源生物科技有限公司2208.8208.88.774.20215.0202.6深圳國賽1其它（請詳述）44204.8203.332.2715.76305.9125.91613所有試劑134.9137.129.8622.13216.016.0Abbott1Beckman1085.880.613.2715.4774.57159.3163.014.679.21182.0134.06146.2142.712.988.88162.0129.0上海長征1101.0北京東雅科美192.6上海科華6139.2143.825.3018.18168.094.9四川邁克13125.5130.038.1830.42167.016.0北京利德曼5135.1137.018.3513.58158.7DiaSys14142.2140.516.54168.8寧波瑞源生物科技有限公司2154.7154.719.6612.71168.6140.8深圳國賽1102.0其它（請詳述）44137.6137.223.1816.85215.089.01614所有試劑75.276.115.8921.13153.81.0Abbott168.0Beckman1056.956.83.345.8761.652.6792.795.89.5310.2899.972.0676.077.44.045.3280.070.0上海長征158.0北京東雅科美147.6上海科華678.180.014.3591.862.9四川邁克1367.568.021.1731.3688.01.0北京利德曼575.075.33.474.6379.069.8DiaSys1485.685.05.396.3093.076.0寧波瑞源生物科技有限公司277.877.82.262.9079.476.2深圳國賽160.1其它（請詳述）4476.475.216.4221.49153.849.01615所有試劑263.6134.01380.48523.7014739.014.0Abbott1Beckman1089.091.210.18102.074.37151.4160.018.16167.06137.2141.08.966.53145.3125.0上海長征170.0北京東雅科美196.1上海科華6139.6142.415.86154.3四川邁克13122.4131.035.8129.26175.014.0北京利德曼5137.0136.025.6618.73173.7101.4DiaSys14154.5149.024.7015.99197.0寧波瑞源生物科技有限公司2133.2133.215.70144.3122.1深圳國賽177.5其它（請詳述）44467.6134.02201.70470.8514739.073.5所有試劑22.022.54.9922.6847.210.4Abbott117.0Beckman1020.020.00.000.0020.020.0718.017.22.0322.216.0OrionDiagnostica116.4623.523.50.823.4924.822.5北京東雅科美110.4上海科華526.523.110.3739.1341.817.4四川邁克1223.724.02.6010.9729.119.5北京利德曼423.923.73.3614.0628.220.0DiaSys1519.919.53.9820.0028.415.0寧波瑞源生物科技有限公司223.423.40.281.2023.623.2深圳國賽120.0其它（請詳述）4722.823.15.4123.7347.21612所有試劑40.139.89.6624.0979.018.3Abbott131.0Beckman1035.735.92.597.2539.332.2727.425.17.9529.0144.921.6OrionDiagnostica118.3639.138.91.854.7342.137.1北京東雅科美150.6上海科華546.038.015.4733.6369.232.4四川邁克1239.840.12.396.0144.236.0北京利德曼446.446.83.557.6549.842.0DiaSys1535.935.76.4017.8345.325.1寧波瑞源生物科技有限公司244.244.20.641.4544.643.7深圳國賽132.8其它（請詳述）4743.642.010.4623.9979.024.21613所有試劑30.631.08.1026.4764.83.3Abbott122.0Beckman1024.222.85.3822.2337.120.0722.721.06.1026.8734.817.3OrionDiagnostica117.8631.131.62.016.4633.427.5北京東雅科美132.1上海科華536.831.210.5928.7849.827.6四川邁克1232.433.03.3310.2837.026.0北京利德曼433.531.93.8439.131.0DiaSys1526.927.74.9718.4834.119.5寧波瑞源生物科技有限公司221.621.625.8839.93.3深圳國賽130.1其它（請詳述）4732.231.67.7223.9864.818.51614所有試劑20.320.64.5722.5142.99.6Abbott115.0Beckman1020.020.00.000.0020.020.0716.215.32.9718.3322.714.2OrionDiagnostica114.1621.821.80.703.2122.920.7北京東雅科美19.6上海科華523.721.110.2943.4238.513.6四川邁克1222.121.52.3110.4527.219.0北京利德曼421.020.72.8213.4324.718.0DiaSys1517.918.33.3518.7224.813.4寧波瑞源生物科技有限公司221.521.50.924.2822.120.8深圳國賽120.0其它（請詳述）4721.021.44.7822.7642.913.01615所有試劑30.730.38.0926.3559.815.5Abbott123.0Beckman1024.925.43.0712.3330.320.0722.220.46.3628.6535.515.5OrionDiagnostica115.5630.230.11.906.2932.427.3北京東雅科美133.5上海科華536.730.212.6734.5255.826.7四川邁克1231.533.14.5214.3538.422.0北京利德曼434.533.34.5813.2841.130.5DiaSys1527.428.74.0614.8235.820.9寧波瑞源生物科技有限公司231.931.91.354.2332.830.9深圳國賽120.6其它（請詳述）4732.432.28.4826.1759.816.0

所有試劑2246.047.46.8514.8954.624.9

Beckman848.547.33.597.4054.644.6

546.449.15.8612.6350.336.2

DiaSys343.342.25.8313.4649.638.1

其它（請詳述）643.848.010.8524.7752.424.9

1612所有試劑22154.2155.021.2813.80192.490.4

Beckman8167.8164.015.799.41192.4151.1

5154.0155.07.74168.0135.0

DiaSys3141.0138.27.565.36149.6135.3

其它（請詳述）6142.9150.129.4020.57165.690.4

1613所有試劑22120.836.9030.55208.558.9

Beckman8127.636.1728.35208.593.4

5134.1135.023.2517.34162.098.4

DiaSys3100.5102.110.1910.14109.889.6

其它（請詳述）698.2107.932.3832.97129.358.9

1614所有試劑2158.159.07.2512.4876.044.1

Beckman859.559.33.876.5066.153.9

563.662.07.4676.056.7

DiaSys352.053.23.807.3155.047.7

其它（請詳述）554.255.09.2217.0163.244.1

1615所有試劑21131.5128.016.9812.91170.0106.0

Beckman8133.2129.510.547.91151.0122.6

5137.8129.018.8313.66170.0125.0

DiaSys3109.810.028.69126.9109.3

其它（請詳述）5108.813.57138.4106.0

轉鐵蛋白所有試劑141.472.5310.901.25

Beckman31.371.408.031.471.25

21.331.330.032.261.351.31

寧波瑞源生物科11.50技有限公司其它（請詳述）63.051.483.85126.2310.901.40

1612所有試劑143.963.541.6341.169.603.23

Beckman33.563.660.298.153.783.23

23.403.400.247.063.573.23

寧波瑞源生物科13.40技有限公司其它（請詳述）64.593.642.4653.599.603.301613所有試劑142.962.282.4783.451.93Beckman32.622.340.8632.823.581.9322.232.230.041.792.252.20寧波瑞源生物科技有限公司12.00其它（請詳述）63.702.163.79102.431.931614所有試劑142.291.622.561.42Beckman31.641.710.1810.981.781.4421.481.480.085.411.541.42寧波瑞源生物科技有限公司11.60其它（請詳述）63.221.653.89120.811.501615所有試劑142.942.352.4081.631.99Beckman32.482.480.010.402.492.4722.272.270.2410.572.442.10寧波瑞源生物科技有限公司12.20其它（請詳述）63.742.323.6998.661.99前白蛋白所有試劑61135.4136.510.948.08163.0Abbott1144.0OrionDiagnostica1160.83139.3140.02.081.49141.0137.0北京東雅科美1132.0上海科華22.261.94四川邁克17132.4134.49.156.91147.0北京利德曼5139.2139.014.8910.70156.0DiaSys6132.5130.510.147.65148.2120.0寧波瑞源生物科技有限公司1132.0其它（請詳述）24137.4139.910.547.67163.01612所有試劑61326.4325.028.748.81414.0264.0Abbott1345.0OrionDiagnostica1368.23312.3313.02.080.67314.0310.0北京東雅科美1307.0上海科華2327.6327.626.097.96346.0309.1四川邁克17313.9314.419.166.10347.0264.0北京利德曼5370.0370.012.193.29385.0354.0DiaSys6302.6303.523.367.72331.7272.7寧波瑞源生物科技有限公司1318.0其它（請詳述）24332.4329.029.588.90414.0279.01613所有試劑61223.9224.031.7114.16326.0168.0Abbott1228.0OrionDiagnostica1258.03229.0224.09.544.17240.0223.0北京東雅科美1185.0上海科華2219.0219.00.000.00219.0219.0四川邁克17221.5219.027.8012.55273.0178.0北京利德曼5240.0244.042.0117.50297.0192.0DiaSys6196.7194.522.50223.1170.0寧波瑞源生物科技有限公司1255.0其它（請詳述）24215.5215.523.0810.71262.0168.01614所有試劑61151.0151.612.108.01182.0125.6Abbott1159.0OrionDiagnostica1181.43152.0150.03.462.28156.0150.0北京東雅科美1150.0上海科華2132.3132.39.487.17139.0125.6四川邁克17149.1151.69.456.34162.0129.0北京利德曼5153.4147.017.14172.0132.0DiaSys6142.6141.47.95156.0130.0寧波瑞源生物科技有限公司1149.0其它（請詳述）24153.9153.67.43182.0138.01615所有試劑61219.3220.031.1614.21309.0146.0Abbott1232.0OrionDiagnostica1208.53217.0220.07.943.66223.0208.0北京東雅科美1217.0上海科華2219.5219.53.541.61222.0217.0四川邁克17217.6212.222.5610.37279.0178.0北京利德曼5223.6217.015.226.81250.0213.0DiaSys6200.0210.021.1910.60217.0166.0寧波瑞源生物科技有限公司1207.0其它（請詳述）24218.0221.433.9215.56287.0146.0特殊蛋白不同檢測項目的正確率，見表。4特殊蛋白不同檢測項目的正確率項目名稱總實驗室數100%及格實驗室數比例%>=80%及格實驗室數比例%<80%及格實驗室數比例%IgG1039390.365.843.9IgA1038885.41211.732.9IgM1038178.61615.565.9C3978789.799.311C4968689.699.411CRP1066561.317162422.7ASO1128374.11917108.9RF1136961.11815.92623IgE221568.2418.2313.6轉鐵蛋白141178.6214.317.1前白蛋白615590.258.211.6特殊蛋白不同方法匯總統計結果，見表。5特殊蛋白不同方法匯總統計結果項目樣本編號方法實驗室數變異系數(%)所有方法1037.127.160.567.878.545.29透射比濁法747.180.588.168.545.29速率散射比濁法197.207.190.466.398.026.15散射比濁法（終點法）87.317.190.375.068.026.9616.271612所有方法10218.3218.201.659.0124.6514.05透射比濁法7318.211.749.5624.6514.05速率散射比濁法1918.8018.861.497.9322.3016.30散射比濁法（終點法）818.5418.450.924.9620.1017.29115.991613所有方法10313.2012.525.0438.1859.868.64透射比濁法7412.4912.541.6413.1318.738.64速率散射比濁法1912.282.0016.2919.039.88散射比濁法（終點法）812.9812.811.128.6315.4012.0011614所有方法1037.467.500.608.048.765.55透射比濁法747.417.490.608.108.745.55速率散射比濁法197.707.750.557.148.536.67散射比濁法（終點法）87.557.370.567.428.767.0516.581615所有方法10313.0712.594.9838.1060.208.54透射比濁法7412.2812.301.4716.268.54速率散射比濁法1912.8012.601.5412.0315.7010.03散射比濁法（終點法）812.5112.421.088.6314.2710.601所有方法1031.061.050.109.431.320.79透射比濁法741.051.050.109.521.310.79速率散射比濁法191.041.020.098.651.320.97散射比濁法（終點法）81.130.076.311.201.0111.081612所有方法1033.643.650.339.075.132.71透射比濁法743.573.610.339.245.132.71速率散射比濁法193.863.870.164.154.123.42散射比濁法（終點法）83.793.750.369.504.443.4013.371613所有方法1032.582.500.4015.503.761.86透射比濁法742.522.490.3112.303.411.86速率散射比濁法192.522.300.4718.653.582.08散射比濁法（終點法）82.762.600.3713.413.392.3912.611614所有方法1031.231.220.108.131.490.96透射比濁法741.221.230.108.201.470.96速率散射比濁法191.231.200.108.131.491.08散射比濁法（終點法）81.301.310.096.921.421.2011.221615所有方法1032.582.530.4015.504.001.80透射比濁法742.502.470.3614.403.441.80速率散射比濁法192.612.640.293.37散射比濁法（終點法）82.642.670.2710.232.972.2512.39所有方法1030.560.540.0814.290.960.30透射比濁法740.550.540.0916.360.960.30速率散射比濁法190.590.610.0610.170.690.42散射比濁法（終點法）80.550.550.035.450.590.5110.491612所有方法1032.082.060.2210.583.101.58透射比濁法742.072.040.233.101.58速率散射比濁法192.152.170.209.302.511.63散射比濁法（終點法）82.102.120.125.712.241.8811.931613所有方法1031.371.320.2618.982.800.94透射比濁法741.331.300.2015.042.070.98速率散射比濁法191.331.300.2216.541.930.94散射比濁法（終點法）81.381.350.161.691.2211.311614所有方法1030.680.620.6189.716.800.40透射比濁法740.620.610.1016.131.060.40速率散射比濁法190.970.681.41145.366.800.51散射比濁法（終點法）80.620.630.046.450.680.5710.561615所有方法10