Abstract Details
9/25/2018 | 11:30 AM - 12:00 PM | Emerald Ballroom I/II
Evaluating the Clinical Sensitivity of Dried Blood Spots to Identify Congenital CMV Infection
Background: The clinical sensitivity of dried blood spots (DBS) to identify newborn children with risk for developing CMV-associated sequelae has not been evaluated in unselected populations using the current, best methods for DBS processing. A study being conducted by the University of Minnesota (UMN), Minnesota Department of Health (MDH), and Centers for Disease Control (CDC) is testing unselected infants to assess DBS for identification of CMV-related sequelae.
Methods: Parental permission is obtained for screening. The study aims to enroll 30,000 infants and identify approximately 30 children with permanent sequelae. Inclusion criteria include all infants born at 5 Minneapolis-St. Paul area hospitals. Saliva swabs are collected 1-2 days after birth and tested at the UMN lab for CMV. DBS from the Minnesota Newborn Screening Program are tested by UMN and CDC labs for CMV. Infants who are CMV positive by saliva or DBS are confirmed by urine testing. CMV-positive infants are referred to MDH Genetic Counselors who provide physicians with educational resources and recommendations for consultation with specialists. Medical records of CMV-infected children will be reviewed annually for 4 years to evaluate for the presence of disabilities associated with congenital CMV infection.
Results to Date: The overall enrollment rate has been 55%; 21% of parents are missed and 24% decline. Enrollment to date is 5958 subjects. CMV birth prevalence is 0.30% (18/5958). Among CMV+ confirmed infants 67% were positive on DBS. Four CMV-positive infants (22%) showed sensorineural hearing loss in the newborn period or later. Clinical evaluations for other symptoms and sequelae are ongoing.
Conclusions: Early results indicate a relatively high analytical sensitivity (67%) for DBS compared to most previous studies that performed unselected screening. The numbers are not yet sufficient to evaluate the clinical sensitivity of DBS for identifying the 20% of infected children at risk for CMV-associated disease.
- Explain the process of diagnosing congenital infection through the study.
- Summarize what universal screening for CMV means.
- Summarize what targeted screening for CMV means.
Presentation:
17739_9629SheliaDollard.pdf
Handouts:
No handouts have been uploaded.
Maggie Dreon (Author,Co-Author), maggie.dreon@state.mn.us;
geneticists
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Nelmary Hernandez-Alvarado (Co-Author), hernande@umn.edu;
Ms. Hernandez-Alvarado is a molecular biology and Director of a CLIA-certified CMV diagnostic laboratory at the University of Minnesota. She has considerable expertise in detection of CMV and in the clinical manifestations of congenital and neonatal CMV infections.
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ASHA DISCLOSURE: Financial - No relevant financial relationship exists. Nonfinancial - No relevant nonfinancial relationship exists. |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Minal Amin (Co-Author), mamin@cdc.gov;
Minal Amin is a Microbiologist in the National Center for Immunization and Respiratory Diseases.
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Phili Wong (Co-Author), pwong@cdc.gov;
lab technologist
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Trenna Lapacininski (Co-Author), trenna.lapacinski@state.mn.us;
technologist
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Tatiana Lanzieri (Co-Author), uyk4@cdc.gov;
Tatiana M. Lanzieri, M.D., M.P.H., is a medical epidemiologist with the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention. She has over 20 years of experience in infectious disease epidemiology, surveillance, and outbreak investigation.
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ASHA DISCLOSURE: Financial - No relevant financial relationship exists. Nonfinancial - No relevant nonfinancial relationship exists. |
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AAA DISCLOSURE: Financial - |
Marcus Gaffney (Co-Author), nzg9@cdc.gov;
Team Lead for EHDI
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Kirstin Coverstone (Co-Author), kristin.coverstone@umn.edu;
Kirsten Coverstone is an audiologist with many years of service dedicated to early hearing detection and intervention. She grew up in southern Minnesota, earned her masters degree from the Univ. of Northern Iowa and her doctorate from Salus University. Kirsten has actively worked at the local state and national levels to promote universal newborn screening for hearing. As coordinator of the Lions Infant Hearing Program at the University of Minnesota she worked directly with hospitals to establish effective hearing screening programs and audiologists to confirm hearing loss. In addition, Kirsten implemented a statewide hearing instrument loaner program for infants and young children in Minnesota. She is dedicated to making a difference in the lives of children and their families as the MDH EHDI Screening Program Coordinator.
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Ruth Lynfield (Co-Author), ruth.lynfield@state.mn.us;
EIP coordinator
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Mark McCann (Co-Author), mark.mccann@state.mn.us;
NBS Lab Director
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ASHA DISCLOSURE: Financial - Nonfinancial - |
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AAA DISCLOSURE: Financial - No relevant financial relationship exists. |
Sheila Dollard (POC-Point of Contact,Primary Presenter), sgd5@cdc.gov;
Sheila Dollard earned her PhD in Biochemistry from the University of Rochester Medical Center, Rochester NY. She joined the Centers for Disease Control and Prevention in 1998 as Team Leader for Herpesvirus Diagnostics where her work has focused on HHV-8 (human herpesvirus 8) and CMV epidemiology and diagnostic assay development to meet U.S. public health needs.
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ASHA DISCLOSURE: Financial - No relevant financial relationship exists. Nonfinancial - No relevant nonfinancial relationship exists. |
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AAA DISCLOSURE: Financial - Receives support from Centers for Disease Control and Prevention. |
Mark R. Schleiss (Co-Presenter), schleiss@umn.edu ;
Dr. Schleiss is a Professor of Pediatrics and holds the American Legion and Auxiliary Endowed Research Chair at the University of Minnesota Medical School. His laboratory is supported by the NIH. He conducts research in small animal models testing vaccine strategies against congenital CMV infection. His laboratory is also engaged in the study of the epidemiology, pathogenesis and management of congenital and neonatal CMV infections.
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ASHA DISCLOSURE: Financial - Receives Consulting fee for Consulting from Merck and GSK Vaccines. Nonfinancial - No relevant nonfinancial relationship exists. |
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AAA DISCLOSURE: Financial - Receives support from Dr. Schleiss is a consultant for Merck and GSK vaccines.. |