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Kalus U, Wilkemeyer I, Caspari G, et al. Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System. Transfus Med Hemother. 2011;38(6):365-372doi: 10.1159/000334481.
Kalus, U., Wilkemeyer, I., Caspari, G., Schroeter, J., & Pruss, A. (2011). Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System. Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie, 38(6), 365-372. https://doi.org/10.1159/000334481
Kalus, Ulrich, et al. "Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System." Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie vol. 38,6 (2011): 365-372. doi: https://doi.org/10.1159/000334481
Kalus U, Wilkemeyer I, Caspari G, Schroeter J, Pruss A. Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System. Transfus Med Hemother. 2011 Dec;38(6):365-372. doi: 10.1159/000334481. Epub 2011 Nov 17. PMID: 22403520; PMCID: PMC3267999.
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Transfus Med Hemother. 2011 Dec;38(6):365-372. doi: 10.1159/000334481. Epub 2011 Nov 17.

Validation of the Serological Testing for Anti-HIV-1/2, Anti-HCV, HBsAg, and Anti-HBc from Post-mortem Blood on the Siemens-BEP-III Automatic System.

Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie

Ulrich Kalus, Ina Wilkemeyer, Gregor Caspari, Jan Schroeter, Axel Pruss

Affiliations

  1. University Tissue Bank, Institute of Transfusion Medicine, Charité - University Medicine Berlin, Germany.

PMID: 22403520 PMCID: PMC3267999 DOI: 10.1159/000334481

Abstract

BACKGROUND: 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.

References

  1. J Med Microbiol. 2011 Jul;60(Pt 7):920-926 - PubMed

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