輸血安全與實(shí)驗(yàn)室檢測(cè)策略

實(shí)驗(yàn)室檢測(cè)方法不同檢測(cè)方法的優(yōu)劣檢測(cè)方法的特點(diǎn)不同檢測(cè)方法互補(bǔ)？不同檢測(cè)方法的優(yōu)劣ELISA成本低，通量大、操作較為簡(jiǎn)便需批量檢測(cè)，質(zhì)控很難與樣本同等對(duì)待全自動(dòng)化學(xué)發(fā)光操作簡(jiǎn)便，質(zhì)控可以與樣本同等對(duì)待成本高核酸檢測(cè)成本高、操作復(fù)雜影響因素多檢測(cè)方法的特點(diǎn)窗口期問題NAT（單人份）NAT（多人份混合）P24抗原HBsAg抗體檢測(cè)（ELISA）HBV8.338.3HCV4.97.458.3HIV5.691622檢測(cè)方法的特點(diǎn)其他國(guó)家數(shù)據(jù)（2009-2010）項(xiàng)目國(guó)家檢測(cè)項(xiàng)目檢測(cè)方法窗口期HBVHCVHIV法國(guó)HBV-DNAHBsAgHCV-RNAAnti-HCVHIV-RNAAnti-HIV兩種NAT檢測(cè)體系：ProcleixTigris；cobass201；ELISANAT（s201(1:6)與Tigris）的平均窗口期較anti-HCV分析，由35.5縮短到30.5天；NAT（s201(1:6)與Tigris）的平均窗口期較anti-HIV分析，由13.5縮短到10.4天；NAT（s201(1:6)與Tigris）的平均窗口期較HBsAg分析，由17.2縮短到12.8天檢測(cè)方法的特點(diǎn)HBsAg檢測(cè)數(shù)據(jù)1樣本號(hào)ROCHECOBASROCHEmurex改進(jìn)中改進(jìn)前PCR基因型血清型突變登記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檢測(cè)方法的特點(diǎn)HBsAg檢測(cè)數(shù)據(jù)2樣本號(hào)ROCHECOBASROCHE

murex改進(jìn)中改進(jìn)前PCR基因型血清型突變登記495未檢出3.192.770.940.39sC1adrq+Q129R169未檢出55.53.451.3-

180未檢出5.535.162.60.68-

214未檢出4.243.291.420.54-

219未檢出4.494.581.670.64-

456未檢出1.291.680.40.29-

469未檢出29.2422.216.145.79-

檢測(cè)方法的特點(diǎn)抗HCV檢測(cè)數(shù)據(jù)1-HCVNAT陽(yáng)性樣本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檢測(cè)方法的特點(diǎn)抗HCV檢測(cè)數(shù)據(jù)2-HCVNAT陰性樣本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檢測(cè)方法的特點(diǎn)抗HCV檢測(cè)數(shù)據(jù)3-HCVNAT陰性樣本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不同檢測(cè)方法互補(bǔ)？替代？HBsAg陰性HBVDNA陽(yáng)性假陽(yáng)性窗口期隨訪血清學(xué)指標(biāo)隱匿性感染血清學(xué)模式:sAb-cAbsAb-eAb-cAbeAb-cAbcAbsAb×HBVDNA陰性隱匿性感染，含量低，假陰性合格血血清學(xué)指標(biāo)全陰或sAb單獨(dú)陽(yáng)性；無HBVDNA的其他血清學(xué)模式不同檢測(cè)方法互補(bǔ)？替代？HBsAg陽(yáng)性HBVDNA陰性假陰性，含量低無復(fù)制的HBVDNA釋放到血液中HBVDNA陽(yáng)性（陽(yáng)性率90%）sAg-eAg-cAb100%sAg-eAb-cAb約83%sAg-cAb約65%sAg少見，95%不同檢測(cè)方法互補(bǔ)？替代？HCVRNA陽(yáng)性陽(yáng)性率與S/CO相關(guān)抗HCV陽(yáng)性≥80%核酸陽(yáng)性﹤20%核酸陰性抗HCV陰性核酸陽(yáng)性-窗口期免疫缺陷抗體假陰性-核酸陽(yáng)性HCVRNA陰性假陰性陰性—合格不同檢測(cè)方法互補(bǔ)？替代？抗HCV與ALT抗HCV與HCVRNAHCVRNA與ALT檢測(cè)程序幾點(diǎn)建議慎重調(diào)整抗原抗體的檢測(cè)試劑HBsAg漏檢，特別是低值或變異株漏檢，往往是