ArticleTransplant infectious disease : an official journal of the Transplantation Society2022
Serological testing on the ADVIA Centaur system for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in specimens from deceased and living individuals demonstrates equivalent results
Article in Transplant infectious disease : an official journal of the Transplantation Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed, 2 citations in OpenAlex.
- Serological testing on the ADVIA Centaur system for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in specimens from deceased and living individuals demonstrates equivalent resultsTransplant infectious disease : an official journal of the Transplantation Society · 2022Article
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Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
Abstract
introductionTo determine the suitability of human tissues and cells for transplantation, guidelines mandate infectious disease testing of serum or plasma obtained from deceased donors, which are often collected after cessation of the heartbeat. Tests used for this purpose are required to show equivalent performance when compared to pre-mortem specimens. This study evaluated whether serology assays for HIV Ag/Ab Combo, hepatitis B virus (HBc Total; HBsAgII), and HCV on the ADVIA Centaur system, were fit for testing post-mortem sera. Performance evaluation studies included precision, specificity, and sensitivity.
methodsBlood specimens were collected within 24 h after death from 82 deceased and 83 healthy living individuals. Studies followed standard guidelines. The 20-day precision study was performed on five levels of post-mortem specimens (non-spiked and spiked). The specificity study compared 81-83 pre-mortem and 74-82 post-mortem specimens. The sensitivity study compared 50 pre-mortem and 50 post-mortem specimens spiked with positive sera for each analyte at two levels to achieve a low (near cutoff) positive result and a second higher positive result.
resultsPrecision, specificity, and sensitivity study results met acceptance criteria for all assays and lots; post-mortem and pre-mortem results were equivalent.
conclusionBased on this study, the ADVIA Centaur CHIV, HBcT, HBsAgII, and HCV assays are acceptable for use in routine testing of deceased donor sera collected after cessation of the heartbeat.
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