Kalus Ulrich, Wilkemeyer Ina, Caspari Gregor, Schroeter Jan, Pruss Axel
University Tissue Bank, Institute of Transfusion Medicine, Charité - University Medicine Berlin, Germany.
Transfus Med Hemother. 2011 Dec;38(6):365-372. doi: 10.1159/000334481. Epub 2011 Nov 17.
Some properties of blood are modified post mortem. These modifications might give false-negative or false-positive results in infectious disease testing. Most CE-marked test equipment for infectious serology testing is not validated for testing post-mortal blood. Validation, however, is obligatory, if the results are used for the release of tissues for transplantation. MATHODS: Samples of pre- and post-mortem sera were obtained from 20 cornea donors, and the results were compared for anti-HIV-1/2, anti-HCV, HBsAg, and anti-HBc on the Siemens-BEP-III Automatic System. Negative post-mortem sera were spiked with standard sera (PEI anti-HCV IgG, PEI HBsAg ad 1000 standard, anti-HBc IgG (WHO) NIBSC 95/522, PEI anti-HIV-IV) in concentrations which give low- and high-positive results for the respective marker. RESULTS: All pre-mortem sera were negative for all markers. None of the post-mortem samples was false-positive. None of the spiked postmortem samples was false-negative. Technical errors occurred during the validation process but could be detected and eliminated. Serum samples should be centrifuged immediately after collection, and it must be taken into account that post-mortem serum could rarely lead to blockage of pipetting systems due to clotting phenomena. CONCLUSION: There is no indication that post-mortem samples give false-negative or false-positve results with the test system and test kits used. The procedure described might serve as a model for validating other test kits on post-mortem samples.
血液的某些特性在死后会发生改变。这些改变可能在传染病检测中产生假阴性或假阳性结果。大多数带有CE标志的传染病血清学检测设备未经验证可用于检测死后血液。然而，如果检测结果用于组织移植放行，则验证是必须的。方法：从20名角膜捐献者处获取生前和死后血清样本，并在西门子-BEP-III自动系统上比较抗HIV-1/2、抗HCV、HBsAg和抗HBc的检测结果。将标准血清（PEI抗HCV IgG、PEI HBsAg ad 1000标准品、抗HBc IgG（WHO）NIBSC 95/522、PEI抗HIV-IV）加入死后阴性血清中，加入浓度能使相应标志物产生低阳性和高阳性结果。结果：所有生前血清的所有标志物检测均为阴性。死后样本无一出现假阳性。加标的死后样本无一出现假阴性。验证过程中出现了技术错误，但可被检测到并消除。血清样本采集后应立即离心，必须考虑到死后血清因凝血现象很少会导致移液系统堵塞。结论：没有迹象表明使用的检测系统和检测试剂盒对死后样本会产生假阴性或假阳性结果。所描述的程序可作为验证其他死后样本检测试剂盒的模型。
