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Improving and assuring newborn screening laboratory quality worldwide: 30-year experience at the Centers for Disease

Víctor R De Jesús1, Joanne V Mei, Carol J Bell

  • 1Newborn Screening Quality Assurance Program, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA. vdejesus@cdc.gov

Seminars in Perinatology
|March 9, 2010
PubMed

Insights

The Centers for Disease Control and Prevention

Area of Science:

  • Public Health
  • Genetics
  • Clinical Diagnostics

Background:

  • Newborn screening is a critical public health initiative in the U.S. for detecting inherited congenital disorders.
  • Accurate and timely screening is essential to prevent long-term health issues in infants.
  • The Centers for Disease Control and Prevention (CDC) plays a vital role in ensuring the quality of these screening programs.

Purpose of the Study:

  • To review the milestones and services of the CDC's Newborn Screening Quality Assurance Program.
  • To highlight the program's contribution to accurate and high-quality newborn screening.
  • To underscore the program's role in supporting laboratories nationwide and globally.

Main Methods:

  • The report reviews historical data and program evolution over 30 years.
  • It details the services provided to enhance laboratory performance in newborn screening.
  • Analysis of program growth in terms of disorders screened and participant laboratories.

Main Results:

  • The CDC's Newborn Screening Quality Assurance Program has successfully supported screening for over 4 million infants annually.
  • The program has expanded significantly, covering more than 50 disorders compared to 1 in 1978.
  • It has consistently ensured accurate detection, minimized false positives, and maintained high-quality performance for participating laboratories.

Conclusions:

  • The CDC's Newborn Screening Quality Assurance Program is a cornerstone of public health, safeguarding infant health through reliable genetic screening.
  • The program's sustained growth and comprehensive services demonstrate its effectiveness and importance to the newborn screening community.
  • Continued support and evolution of this program are crucial for addressing the challenges of inherited disorders in newborns.

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