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9/24/2018  |   1:45 PM - 2:15 PM   |  Diamond II Ballroom

Evaluation of the Illumigene Assay for Newborn Cytomegalovirus Screening Using Oral Swab Samples

Background. Congenital CMV infection is a major cause of childhood disability, but typically goes undiagnosed. Newborn CMV screening may therefore improve neurodevelopmental outcomes. Oral swabs appear to be the optimal sample for newborn CMV screening because very high viral loads are shed in saliva. The illumigene assay is an investigational-use only LAMP (loop-mediated isothermal amplification) kit suitable for rapid CMV saliva swab testing outside of reference laboratories. Objective. Evaluate the illumigene CMV assay compared with reference testing of oral swabs. Data source and methods. Saliva swabs collected prospectively from neonates <21 days old were tested within 7 days using illumigene CMV kits (not approved for clinical use) with illumipro-10™ instruments at four clinical sites. Centralized confirmatory testing was conducted using two separate PCR assays followed by bi-directional sequencing (“composite reference method”, CRM). An additional retrospective set of frozen newborn oral swabs found to be positive using sites’ validated clinical CMV assays were also tested by illumigene and CRM in a blinded fashion. Results. Prospective samples were obtained from 1,133 newborns, of which three (0.26%) were positive by both illumigene and CRM, one (0.09%) was positive by illumigene only, and 1,129 (99.6%) were negative by all methods. This resulted in a sensitivity of 100% (95% CI: 43.8-100.0%) and a specificity of 99.9% (95% CI: 99.5-100.0%) relative to CRM as the gold standard. Of the 38 reportedly CMV-positive retrospective samples, 34 (89.5%) were positive both by illumigene and CRM; three (7.9%) were positive only by illumigene, and one was negative by both illumigene and CRM. Conclusion and relevance. These data suggest the illumigene CMV assay may be a valuable method for detecting CMV in newborn oral swabs. This, combined with ease of use and ability to provide results in under an hour, make illumigene an attractive platform for decentralized congenital CMV screening.

  • Optimal sample type for newborn CMV screening
  • Logistal issues related to large-scale newborn CMV screening
  • Performance of the illumigene assay for newborn CMV screening using oral swabs

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David M. Goldfarb (Co-Author), David.Goldfarb@cw.bc.ca;
Dr. Goldfarb is a Medical Microbiologist at BC Children's Hospital in Vancouver, Canada.

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      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Wendy van Zuylen (Co-Author), w.vanzuijlen@unsw.edu.au;
Dr Wendy van Zuijlen is a Postdoctoral Scientist at the Virology Research Laboratory in the School of Medical Sciences at the University of New South Wales. She completed her PhD in immunology at the Institute for Molecular Bioscience at the University of Queensland. She then undertook postdoctoral training at the University of Montreal in Canada, funded by a fellowship from the Societé Québécoise d’Hypertension Artérielle, working on cell signalling and the immune response to viral infection. Her current research investigates how Cytomegalovirus is able to infect the placenta. This virus is harmless for pregnant women, but is now the leading infectious cause of disability in newborns. Cytomegalovirus in the expectant mother's blood can infect the developing baby and may cause hearing loss and intellectual disability. Dr van Zuijlen's research aims to identify therapeutics to prevent and treat Cytomegalovirus infection during pregnancy.

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      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




William Rawlinson (Co-Author), w.rawlinson@unsw.edu.au;
Dr. William Rawlinson is the Director of Virology, Department of Microbiology SEALS, with a conjoint position in the Department of Infectious Diseases, Prince of Wales Hospital. He is Professor in the faculties of Medicine and Science at UNSW, currently supervising PhD students researching CMV diagnosis, CMV antiviral resistance in transplantation, and testing for blood borne viruses (BBV) in transplantation. He has studied CMV infection in different settings since completing his PhD in the molecular biology of CMV. Most recently these studies have been of the adverse consequences of CMV in at-risk populations, using in vitro models. The Diagnostic Virology Laboratory he heads provides a range of molecular assays for CMV including antiviral resistance testing, and most recently ganciclovir levels using mass spectrometry. He consults on viral infections and general infectious diseases at Prince of Wales, Sydney Children’s and the Royal Hospital for Women.

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Financial - No relevant financial relationship exists.




Heather T. Thiesset (Co-Author), Heather.Thiesset@hsc.utah.edu;
Heather F Thiesset is currently working as an eminent faculty member at Department of Surgery, University of Utah in United States. He has published numerous research papers and articles in reputed journals and has various other achievements in the related studies. He has extended his valuable service towards the scientific community with his extensive research work.

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Financial - No relevant financial relationship exists.




Albert Park (Co-Author), albert.park@imail.org;
Albert Park, MD, serves as the section chief of pediatric otolaryngology and professor within the Department of Surgery and the Department of Pediatrics at the University of Utah. Dr. Park obtained his MD at the Washington University School of Medicine. He then completed his residency training at Loyola University Medical Center and pediatric otolaryngology fellowship training at the Hospital for Sick Children in Toronto, Canada. His primary research interest focuses on understanding the pathophysiology of congenital cytomegalovirus (CMV) induced hearing loss and developing novel assays for diagnosis.

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Financial - No relevant financial relationship exists.




Suni Patil (Co-Author), spati@peds.uab.edu;
Research Associate at The University of Alabama at Birmingham

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Misty Purser Latting (Co-Author), mlpurser@uab.edu;
Unavailable

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Suresh Boppana (Co-Author), sboppana@peds.uab.edu;
Dr. Boppana is a Professor in the Division of Infectious Diseases in the Department of Pediatrics and was the PI of the NIDCD CHIMES Study.

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      AAA DISCLOSURE:

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Soren Gantt (Primary Presenter), sgantt@bcchr.ca;
Dr. Gantt is a pediatric infectious diseases physician and virology researcher at BC Children's Hospital in Vancouver, Canada.

      ASHA DISCLOSURE:

Financial - Receives Consulting fee for Consulting from GSK.   Receives Consulting fee for Consulting from Merck.   Receives Consulting fee for Consulting from Merck and GSK.  

Nonfinancial - No relevant nonfinancial relationship exists.


      AAA DISCLOSURE:

Financial - Receives support from Meridian Bioscience, Inc. GSK Merck.