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 ƚ

Author:

Wright Theodore B.1,Patibandla Sai1,Walsh Renee1,Fonstad Rachel1,Gee Matthew1,Bitcon Vera1,Hopper Julie2,Braniff Susie J.3,Best Susan3,Read Scott4

Affiliation:

1. Laboratory Diagnostics Siemens Healthcare Diagnostics Inc. Tarrytown New York USA

2. Laboratory Diagnostics Inc. Siemens Healthcare Diagnostics Inc. Walpole Massachusetts USA

3. National Serology Reference Laboratory Fitzroy Victoria Australia

4. Laboratory Diagnostics Siemens Healthcare Pty Ltd. Bayswater Victoria Australia

Publisher

Wiley

Subject

Infectious Diseases,Transplantation

Reference29 articles.

1. Probability of Viremia with HBV, HCV, HIV, and HTLV among Tissue Donors in the United States

2. US Food and Drug Administration.Guidance for industry: recommnedations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood specimens from donors of human cells tissues and cellular and tissue‐based products (HCT/Ps).2004.http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073972.htmAccessed March 18 2021.

3. Food and Drug Administration.Testing human cells tissues and cellular and tissue based product (HCT/P) donors for relevant communicable disease agents and diseases.2021.https://www.fda.gov/vaccines‐blood‐biologics/safety‐availability‐biologics/testing‐human‐cells‐tissues‐and‐cellular‐and‐tissue‐based‐product‐hctp‐donors‐relevant‐communicableAccessed March 18 2021.

4. US Food and Drug Administration.Eligibility determination for donors of human cells tissues and cellular and tissue‐based products; guidance for industry.2007.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/eligibility‐determination‐donors‐human‐cells‐tissues‐and‐cellular‐and‐tissue‐based‐products

5. CDC.Transplant safety/protecting patients/donor screening and testing.2019.https://www.cdc.gov/transplantsafety/protecting‐patient/screening‐testing.htmlAccessed March 18 2021.

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