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9/25/2018  |   11:30 AM - 12:00 PM   |  Emerald Ballroom I

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.

  • diagnosing congenital infection
  • universal screening
  • targeted screening

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Maggie Dreon (Author,Co-Author), maggie.dreon@state.mn.us;
geneticists

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Nelmary Hernandez-Alvarado (Co-Author), hernande@umn.edu;
lab technologist

      ASHA DISCLOSURE:

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.


      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.

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Phili Wong (Co-Author), pwong@cdc.gov;
lab technologist

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Trenna Lapacininski (Co-Author), trenna.lapacinski@state.mn.us;
technologist

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Tatiana Lanzieri (Co-Author), uyk4@cdc.gov;
Tatiana Lanzieri is a medical epidemiologist in the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention.

      ASHA DISCLOSURE:

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.


      AAA DISCLOSURE:

Financial -




Marcus Gaffney (Co-Author), nzg9@cdc.gov;
Team Lead for EHDI

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Kirstin Coverstone (Co-Author), kristin.coverstone@umn.edu;
EHDI Coordinator

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Ruth Lynfield (Co-Author), ruth.lynfield@state.mn.us;
EIP coordinator

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      AAA DISCLOSURE:

Financial - No relevant financial relationship exists.




Mark McCann (Co-Author), mark.mccann@state.mn.us;
NBS Lab Director

      ASHA DISCLOSURE:

Financial -

Nonfinancial -


      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 in 1991 from the University of Rochester Medical Center, Rochester. Her research focused on gene transcription and tissue specificity of human papillomaviruses. From 1992-1995 she was a post-doctoral fellow studying HIV gene transcription and pathogenesis in the Department of Microbiology at the University of Rochester. From 1995-1997 she served as Instructor and Fellow in the Residency Program in Public Health Laboratory Microbiology at Strong Memorial Hospital. In 1998 Dr. Dollard joined the Centers for Disease Control and Prevention as Team Leader for Herpesvirus Diagnostic Development where her work has focused on HHV-8 (human herpesvirus 8) and CMV epidemiology and diagnostics for the past 16 years. Dr. Dollard has been a co-Investigator on numerous NIH grants for HHV-8 and CMV. She has authored and co-authored over 60 papers in peer-reviewed journals and has co-authored 4 book chapters for HHV-8 and CMV.

      ASHA DISCLOSURE:

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.


      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 and March of Dimes Birth Defects Foundation. 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.

      ASHA DISCLOSURE:

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

Nonfinancial - No relevant nonfinancial relationship exists.


      AAA DISCLOSURE:

Financial - Receives support from Dr. Schleiss is a consultant for Merck and GSK vaccines..