Discordant Serology and Nucleic Acid Testing Results for HIV, HBV and HCV in 2010 Nicole Theodoropoulos 1,3 , Marek Nowicki 4 , Claudia Chinchilla-Reyes 4 , Carol Pancoska 5 , Andres Jaramillo 6 , Tom Mone 7 , Rick Hasz 8 , Martin D. Jendrisak 6 , Daniela P Ladner 2,3 , Michael G Ison 1-3 - PowerPoint PPT Presentation
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Discordant Serology and Nucleic Acid Testing Results for HIV, HBV and HCV in 2010
Nicole Theodoropoulos1,3, Marek Nowicki4, Claudia Chinchilla-Reyes4, Carol Pancoska5, Andres Jaramillo6, Tom Mone7, Rick Hasz8, Martin
D. Jendrisak6, Daniela P Ladner2,3, Michael G Ison1-3
1Divisions of Infectious Diseases and 2Organ Transplantation, 3Northwestern University Transplant Outcomes Research Collaborative, Northwestern University, 4Mendez National
Institute of Transplantation, 5Labs Inc, 6Gift of Hope Organ & Tissue Donor Network, 7OneLegacy, 8Gift of Life Donor Program
American Transplant Congress – Boston, MassachusettsJune 3, 2012
*Waiting list deaths includes removals for death, too sick to transplant, and those non-transplanted removals identified to have died within seven days of removal from linkage to SSDMF data. Based on OPTN data as of April 16, 2010.
o Requires OPO to: Obtain a medical & social history of the donor Review the donor’s chart Perform a physical examination of the donor Perform FDA licensed, approved, or cleared screening tests
• Serology for: HIV, HCV, HBsAg, HBcAb, CMV, EBV, and syphilis• Additional testing may be done at the discretion of the OPO or accepting
transplant center
• OPTN Policy 4.1: Screening Donors for HIVo Prohibits the use of donors with + HIV test resulto Defines a donor at “increased risk of HIV, HBV or HCV transmission”
OPO must inform transplant center if the donor is increased risk Transplant Center must obtain special consent from the recipient to use
organs from an increased risk donor
http://optn.transplant.hrsa.gov/policiesAndBylaws/policies.aspRogers et al. MMWR. 1994; 43(RR-8):1-17.
• Screening data on all potential deceased organ donors was obtained from 3 US OPO-affiliated laboratories in 2010, representing:o 15 Organ Procurement Organizationso ~35% of the US Donor Pool
• All potential deceased organ donors were screened for HIV, HBV, and HCV according to current OPTN Policyo Genetic Systems HIV-1/HIV-2 plus O EIA (Bio-Rad Laboratories)o Genetic Systems HBsAg EIA 3.0 (Bio-Rad Laboratories)o ORTHO HBc ELISA Test System (Ortho-Clinical Diagnostics, Inc.)o ORTHO HCV Version 3.0 ELISA Test System (Ortho-Clinical
Diagnostics, Inc.)o All assays performed according to the package insert
• 10 HIV seronegative donors with + NATo One PCR-based labo 2/10 NAT were repeated and were found to be non-
reproducibly positive (NRP)o The lab performed an extensive quality investigation
Examination of the equipment and lab by the assay manufacturer Re-training of lab technicians Technician monitoring Machine sterilization No definite root cause was determined Lab changed to a TMA NAT platform
• Lab C used TMA for NATo Built-in confirmatory stepo All initial NAT + results were confirmed by discriminatory assay
• We intend to ask OPOs to share their primary donor screening data
• We plan to link this data with OPTN donor data to determineo The true incidence of seronegative, NAT positive donorso The effect of NAT screening on organ utilizationo The false positive rates of NAT in the deceased organ donor
populationo The effect of the type of NAT assay (PCR vs TMA) on false
positive results
• All donor screening results should be collected in a national database