Ulrich Kalus1, Ina Wilkemeyer1, Axel Pruß1, G. Caspari2
1University Tissue Bank, Institute of Transfusion Medicine, Charité - University Medicine Berlin, Germany.
2LADR GmbH, Medical Care Center Berlin, Berlin, Germany.
Tóm tắt
<b><i>Summary</i></b><b><i>Background: </i></b>Infectious disease marker testing is obligatory for the release of human tissue for transplantation. Most CE-marked tests are not validated for postmortem blood. In a previous study we have validated the testing for anti-HIV-1/2, anti-HCV, HBsAg, and anti-HBc. Here, we present the validation of testing for antibodies against <i>T. pallidum</i>, which is the last marker obligatory for tissue release for transplantation. <b><i>Methods: </i></b>17 samples of postmortem sera and 10 samples of both pre- und postmortem sera were obtained from cornea donors and tested for anti-<i>T. pallidum</i> on the Siemens-BEP-III-System. These sera were spiked with anti-<i>T. pallidum</i>-positive standard sera in concentrations which give low- and high-positive results at the respective dilution. <b><i>Results: </i></b>Two of the unspiked postmortem sera were false-positive most likely due to intense hemolysis (free hemoglobin > 50 mg/dl). Of the 25 negative postmortem sera, none of the spiked samples was false-negative after 0, 24 and 60 h. <b><i>Conclusion: </i></b>There is no indication that postmortem samples give false-negative or false-positive results with the test system and test kits used in cases of low hemolysis. The procedure described might serve as a model for validating other test kits on postmortem samples.
