1250. False Positive Hepatitis C Virus Serology after Placement of a Ventricular Assist Device
Session: Oral Abstract Session: Laboratory and Clinical Virology
Saturday, October 5, 2013: 10:30 AM
Room: The Moscone Center: 300
Background: Ventricular assist devices (VAD) have been associated with immunoreactivity.  We observed several cases of false positive (FP) hepatitis C virus (HCV) antibody (Ab) tests in patients with a VAD being evaluated for orthotopic heart transplant (OHT), prompting us to investigate this further. 

Methods: All consecutive patients who had a VAD and/or OHT and available pre- and post-VAD/OHT HCV serology at Johns Hopkins were retrospectively reviewed from 1/1/2005- 12/31/2012.  We determined the incidence of FP HCV serology, defined as an equivocal or low positive HCV Ab plus (i) negative recombinant immunoblot (RIBA) and/or HCV nucleic acid test (NAT) or (ii) indeterminate RIBA and negative NAT.  Assays included:  HCV Ab from 1/1/2005-7/10/2006 with AxSYM microparticle assay (Abbott) and from 7/11/2006-12/31/2012 with Advia Centaur chemiluminescent immunoassay (Siemens), RIBA: with CHIRON HCV 3.0 SIA.

Results:

Fifty-three patients had a VAD and HCV testing pre- and post- VAD placement; 25 (47%) had OHT subsequently.  Thirty-three (65%), 14 (26%), and 3 (6%) patients had 1, 2 and 3 VAD(s) placed, respectively.   The majority of patients (49/53, 92%) had HeartMate II VADs (Thoratec).   FP HCV Ab tests occurred after VAD in 21/53 (39.6%) patients: 4 patients had negative NAT, 12 had negative RIBA, and 5 had an indeterminate RIBA and negative NAT.  In all 5 indeterminate RIBA tests, isolated reactivity to c100p/5-1-1p (NS4 protein) was observed.   In 3 of 4 VAD patients who had OHT and had repeat HCV Ab testing after VAD removal, repeat HCV Ab was negative (range: 699-947 days after OHT); in one case, FP HCV serology persisted (tested 5 days after OHT).  Thirteen patients had OHT alone and 100% remained negative for HCV Ab.

Conclusion: More than one third of patients had FP HCV Ab testing after VAD placement, requiring additional testing.  RIBA was indeterminate in almost one third of patients with a reactive HCV Ab screen, requiring a third test.  These high rates of FP results could lead to delays in determining eligibility for OHT and increased costs.  Reversal of FP HCV serology in several patients after VAD removal is suggestive of a possible association with the VAD hardware.

Christine Durand, MD1, Kieren A. Marr, MD, FIDSA2, Darin Ostrander, PhD3, Aruna Subramanian, MD4, Alexandra Valsamakis, MD, PhD5, Andrea Cox, MD, PhD1 and Dionissios Neofytos, MD, MPH6, (1)Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, (2)Medicine & Oncology, The Johns Hopkins Hospital, Baltimore, MD, (3)The Johns Hopkins Hospital, Baltimore, MD, (4)Johns Hopkins University School of Medicine, Baltimore, MD, (5)Johns Hopkins Medical Institutions, Baltimore, MD, (6)Johns Hopkins, Baltimore, MD

Disclosures:

C. Durand, None

K. A. Marr, Pfizer: Investigator, Research grant and Research support
Astellas: Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Merck: Investigator, Research grant and Research support

D. Ostrander, None

A. Subramanian, None

A. Valsamakis, None

A. Cox, None

D. Neofytos, None

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