输血安全与实验室检测策略

实验室检测方法不同检测方法的优劣检测方法的特点不同检测方法互补？不同检测方法的优劣ELISA成本低，通量大、操作较为简便需批量检测，质控很难与样本同等对待全自动化学发光操作简便，质控可以与样本同等对待成本高核酸检测成本高、操作复杂影响因素多检测方法的特点窗口期问题NAT（单人份）NAT（多人份混合）P24抗原HBsAg抗体检测（ELISA）HBV8.338.3HCV4.97.458.3HIV5.691622检测方法的特点其他国家数据（2009-2010）项目国家检测项目检测方法窗口期HBVHCVHIV法国HBV-DNAHBsAgHCV-RNAAnti-HCVHIV-RNAAnti-HIV两种NAT检测体系：ProcleixTigris；cobass201；ELISANAT（s201(1:6)与Tigris）的平均窗口期较anti-HCV分析，由35.5缩短到30.5天；NAT（s201(1:6)与Tigris）的平均窗口期较anti-HIV分析，由13.5缩短到10.4天；NAT（s201(1:6)与Tigris）的平均窗口期较HBsAg分析，由17.2缩短到12.8天检测方法的特点HBsAg检测数据1样本号ROCHECOBASROCHEmurex改进中改进前PCR基因型血清型突变登记492<12IU/ml1.151.320.060.22-

181<12IU/ml4.6111.54.910.43-

198<12IU/ml4.14.782.220.74-

434<12IU/ml2.932.550.820.47-

461<12IU/ml6.54.512.341.18sB2adw2V96AY100CG101RI110LV168AM198I47037.6IU/ml3.534.241.70.68-

4154.4IU/ml3.477.632.610.31sB2adw2N40SG130ET131NF134LG145RL175SV177L检测方法的特点HBsAg检测数据2样本号ROCHECOBASROCHE

murex改进中改进前PCR基因型血清型突变登记495未检出3.192.770.940.39sC1adrq+Q129R169未检出55.53.451.3-

180未检出5.535.162.60.68-

214未检出4.243.291.420.54-

219未检出4.494.581.670.64-

456未检出1.291.680.40.29-

469未检出29.2422.216.145.79-

检测方法的特点抗HCV检测数据1-HCVNAT阳性样本C100C33cC22cNS5ROCHEMUWTBRJOHNLZSRXCKH6012±+3+±112.21.9047.6710.791.5812.5883.74821.9575.25260843+3+--0.7760.1710.0571.6920.1910.0822.8070.1210.3436090-4+--3.780.1476.3932.7452.6177.8652.6180.1366.3766140±±±±0.1940.3360.050.1680.1020.5410.2440.1430.0996416-4+-±0.5163.0665.7212.4931.7025.51.4166.7793.9344101±2+3++356.3

2.5075.0791.7831.9197.7530.39110.4214.7664118+3+2+±251.53.8842.0430.5330.7051.2530.8914.9143.617检测方法的特点抗HCV检测数据2-HCVNAT阴性样本C100C33cC22cNS5ROCHEMUWTBRJOHNLZSRXCKH6131-+4+±353.3518.2712.6973.39115.4064.94122.2937.3144092-++±250.62.7214.3210.6330.9985.4761.98715.1213.6463035±+++56.470.85911.0571.0372.6650.5886.4791.6286085-3++±0.4841.120.7210.2590.227.1350.3821.5430.5474064++4+-32.724.1938.2292.5583.0147.1653.15117.8645.1064068±+4++2.560.490.9430.2990.0992.0470.130.1860.1024087+2+2+±0.9621.4670.8710.330.3551.9760.5254.2931.1574091++3+-1.37320.0790.6040.6252.9471.2690.3211.8984093-++-0.320.1512.3640.3250.0672.1880.1390.6640.1464097-3++-0.462.230.1710.8280.9224.6060.6510.4071.8214100±2++±1.220.3740.350.3910.1531.6120.2350.1291.5584102-2+-2+2.231.9910.0640.9490.2732.6760.4540.3290.12检测方法的特点抗HCV检测数据3-HCVNAT阴性样本C100C33cC22cNS5ROCHEMUWTBRJOHNLZSRXCKH6071±±-+0.0520.150.0290.2280.1470.2760.1010.1290.2856072±±±±0.0390.1390.050.1410.0790.1650.1180.1360.0996076-±-+0.2530.1210.0640.5571.4220.1710.1430.6360.0996098-4+--0.1182.2240.9641.3430.7632.7761.2310.7641.1576019±±±±0.0930.1610.0710.2481.1710.4880.2650.1360.1066009-±-±0.0880.2110.0430.2921.40.2591.1760.1290.1026016--+-0.1420.1460.050.2083.4820.2410.2350.1210.0956036±±-±0.152.610.0570.3960.2050.4880.1550.1860.1064162--+-0.1540.2590.0790.2460.1433.2710.1640.250.1026111±±-±0.1220.0091.3860.2370.1074.0530.1050.7430.102不同检测方法互补？替代？HBsAg阴性HBVDNA阳性假阳性窗口期随访血清学指标隐匿性感染血清学模式:sAb-cAbsAb-eAb-cAbeAb-cAbcAbsAb×HBVDNA阴性隐匿性感染，含量低，假阴性合格血血清学指标全阴或sAb单独阳性；无HBVDNA的其他血清学模式不同检测方法互补？替代？HBsAg阳性HBVDNA阴性假阴性，含量低无复制的HBVDNA释放到血液中HBVDNA阳性（阳性率90%）sAg-eAg-cAb100%sAg-eAb-cAb约83%sAg-cAb约65%sAg少见，95%不同检测方法互补？替代？HCVRNA阳性阳性率与S/CO相关抗HCV阳性≥80%核酸阳性﹤20%核酸阴性抗HCV阴性核酸阳性-窗口期免疫缺陷抗体假阴性-核酸阳性HCVRNA阴性假阴性阴性—合格不同检测方法互补？替代？抗HCV与ALT抗HCV与HCVRNAHCVRNA与ALT检测程序几点建议慎重调整抗原抗体的检测试剂HBsAg漏检，特别是低值或变异株漏检，往往是