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10/10/2023  |   11:15 AM - 11:40 AM   |  6613

Clinical Sensitivity of Saliva and Dried Blood Spot PCR and Infant Outcomes from a Congenital CMV Newborn Screening Study: 2016-2022

Abstract Summary

Background: Congenital cytomegalovirus (cCMV) infection is the most common viral infection causing disability in U.S. children. A universal cCMV screening study evaluated dried blood spots (DBS) and saliva PCR for cCMV detection (analytical sensitivity), and identification of CMV disease (clinical sensitivity). Design/Methods: In six newborn nurseries in Minnesota, consented newborns were screened for cCMV by PCR using saliva collected 1-2 days after birth, and DBS obtained for routine newborn screening. Following confirmation of screen-positive cases, diagnostic evaluation classified cCMV (doi:10.1016/S1473-3099(17)30143-3) as: moderately-to-severely symptomatic; mildly symptomatic; asymptomatic with isolated sensorineural hearing loss (SNHL); or asymptomatic. Results: From February 2016–December 2022, among 23,644 newborns screened, 87 (3.7 per 1,000) cCMV cases were identified. A total of 19 (22%) were treated with valganciclovir. Analytical sensitivity of saliva was 93.1% (81) and, for DBS PCR, 73.6% (64) by the UMN lab and 77.0% (67) by the CDC lab. At birth, 68 (78%) infants were asymptomatic; 6 moderately-to-severely symptomatic (2 with sensorineural hearing loss [SNHL]); 9 mildly symptomatic; and 4 asymptomatic with isolated SNHL. 4 additional infants had delayed-onset SNHL (2 in asymptomatics, and 2 in symptomatics); in total, 10/87 (11.5%) had some degree of SNHL. Among 21 infants with symptomatic cCMV at birth and/or SNHL, or infants classified initially as asymptomatic that went on to demonstrate SNHL, clinical sensitivity of saliva testing was 95% (20), and for DBS testing, 81% (17) by the UMN lab and 90% (19) by the CDC lab. Conclusions: This unselected screening study demonstrated a cCMV prevalence of 3.7/1000. Enhancement in clinical sensitivity of DBS (over analytical sensitivity) to identify children with symptoms or sequelae suggests their potential usefulness for cCMV screening. Continued evaluation of DBS testing methods for reproducibility, efficiency and high-throughput capability in state public health laboratories will be an important consideration for universal cCMV screening programs.

Learning Objectives

  • 1. Be aware of the current status of newborn screening for congenital CMV including the options of saliva-based screening and dried blood spot (DBS)-based screening approaches.
  • 2. Distinguish between analytical sensitivity and clinical sensitivity when those terms are applied to discussion of universal congenital CMV screening.
  • 3. Know the relative sensitivity of saliva and DBS PCR when evaluated in a universal congenital CMV screening study in Minnesota and be familiar with disease categorization and classification of identified congenital CMV cases in this study.

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Presenters


Mark R. Schleiss | POC-Point of Contact, Primary Presenter, Author

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.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Erin Osterholm | Co-Author

oste0123@umn.edu;
Dr. Osterholm is Medical Director of the Newborn Intensive Care Unit at the University of Minnesota Medical School and a faculty member in the Division of Neonatology. She is interested in the clinical implications of CMV on neurodevelopment in both preterm and term infants.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Rebecca Kruc | Co-Author

rebeccakruc@gmail.com;
Rebecca Kruc is a current pediatric resident at Mayo Clinic in Rochester Minnesota. She holds her MPH degree and formerly worked for the Centers for Disease Control and the Minnesota Department of Health. She is interested in global health, pediatric infectious disease prevention, and epidemiology.

ASHA DISCLOSURE

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Nelmary Hernandez-Alvarado | Co-Author

nelmary.hernandez@gmail.com;
Ms. Hernandez-Alvarado is a molecular biologist and was formerly the Director of a CLIA-certified CMV diagnostic laboratory at the University of Minnesota. Her work focused on the detection of CMV and the clinical presentation of congenital and neonatal CMV infections. She contributed to this project during her time at the University of Minnesota.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Mark Blackstad | Co-Author

black114@umn.edu;
Mr. Blackstad is a molecular virologist and researcher with expertise in PCR-based diagnostics for cytomegalovirus.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Hannah Herd | Co-Author

hannah.herd@fairview.org;

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - Receives support from Fairview Health Services for -Fairview Health Services: employment (salary) -Research funding from Lions Hearing Foundation of Minnesota and National Institute of Health -Minnesota Department of Health, Newborn Hearing Screening Advisory Committee Member -Minnesota Academy of Audiology, Membership Development Committee Member.  


Sondra Rosendahl | Co-Author

sondra.rosendahl@state.mn.us;
Sondra is a licensed genetic counselor who has been with the Minnesota Department of Health (MDH) Newborn Screening Program since 2011. Sondra is the coordinator of MDH’s Advisory Committee on Heritable and Congenital Disorders whose role is to provide advice and recommendations to the Minnesota Commissioner of Health concerning tests and treatments for disorders found in newborn children.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Kirsten Coverstone | Co-Author

kirsten.coverstone@state.mn.us;
Dr. Kirsten Coverstone is an audiologist at the Minnesota Department of Health (MDH) Newborn Screening Program. As a coordinator of Minnesota’s EHDI program, Kirsten has worked at the local, state, and national levels to support best practice for universal newborn screening, timely & complete audiologic follow-up for hearing, and early access to intervention. In addition, Kirsten implemented the statewide hearing instrument loaner program for infants and young children in Minnesota. Universal screening, education, and follow-up for congenital cytomegalovirus (cCMV) has been a longstanding aspiration as cCMV is the leading cause of non-genetic hearing loss and is intricately related to EHDI. She has served as Co-Chair of the Joint Committee on Infant Hearing (JCIH), & Co-Chair of the Center for Disease Control (CDC) EHDI Data Committee.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Sheila Dollard | Co-Author

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.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Tatiana Lanzieri | Co-Presenter, Author, 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.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.