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Division of Laboratory Sciences

Image: newborn screening

Most Recent Program Reports

Summary Report Inborn Errors of Metabolism (January 2004)

Summary Report Tandem Mass Spectrometry (February 2004)

Midyear QC Report (July 2004)


Annual Summary and Midyear QC Reports (2003, 2002)

Adobe Acrobat Reader™ software is required to view these reports. Download a free copy of the Adobe Acrobat Reader™.

One Page Summary of Program

Tandem Mass Spectrometry QC/QA for Newborn Screening Web Conference - Jan/Feb 2004

NEWBORN SCREENING

Background
Newborn Screening Quality Assurance Program
Applications of Bloodspot Technology
Newborn Screening and Bloodspot Technology Services Available
Important Links to Learn More About Newborn Screening and Related Topics
Newborn Screening Request Participation Form

Background

Newborn screening is one of the largest disease prevention programs in the United States, reaching approximately 4 million babies born each year. States test blood spots collected from newborns for metabolic and genetic diseases such as phenylketonuria (PKU), hypothyroidism, galactosemia, and sickle cell disease. In addition, a few states and private laboratories have more comprehensive programs that screen for more than 30 disorders. Affected newborns are identified quickly and treated to prevent mental retardation, severe illness, and premature death.

Accurate screening for newborn diseases is of critical importance to ensure that affected newborns are identified quickly, to avoid missing any cases, and to minimize "false positive" results that can cause parental anxiety. The irreversible nature of the outcomes of missed cases requires testing to be of the highest quality.

Newborn Screening Quality Assurance Program

The Newborn Screening Branch, Division of Laboratory Sciences, operates the Newborn Screening Quality Assurance Program (NSQAP). NSQAP is a voluntary, non-regulatory program to help state health departments and their laboratories maintain and enhance the quality of test results. The program is operated in partnership with the Association of Public Health Laboratories. The program provides services to more than 73 domestic newborn screening laboratories, 28 manufacturers of diagnostic products, and laboratories in 53 countries. NSQAP has been the only comprehensive source of essential quality assurance services for dried-blood-spot testing for over 26 years.

Services provided by NSQAP to participating laboratories include: (1) training, (2) guidelines, (3) consultation, (4) proficiency testing, and (5) reference materials. The proficiency testing services provide coded specimens to participating laboratories to see if they arrive at the expected answer. If a participating laboratory does not get the correct answer, NSQAP immediately works with the laboratory to identify and solve the problem. NSQAP publishes quarterly reports on the performance of participating laboratories.

Each year approximately 3,000 babies with severe disorders are identified in the United States using newborn screening programs. The field of newborn screening is rapidly expanding because of new technologies and genetic discoveries. As states adopt new tests for additional diseases, the NSQAP will need to extend its services to ensure the quality of test results.

If you are interested in participating in this program, please click here to see an overview of the quality assurance program.

Applications of Bloodspot Technology

A large number and variety of substances have been measured using dried-blood spots. Click here to see a list obtained from literature citations for an indication of applications for this versatile matrix.

NSQAP has conducted research and provided technical assistance in using dried-blood spots to measure autoantibodies related to type 1 diabetes. NSQAP has conducted two workshops on this topic and recently obtained funding from the National Institutes of Health to develop a pilot program for population-based screening for type 1 diabetes using newborn bloodspots.

NSQAP also applies its bloodspot technology to detect HIV-1 antibodies. NSQAP has provided quality assurance services for surveys of HIV infection and consultation services for other applications of bloodspot technology.

Newborn Screening and Bloodspot Technology Services Available

NSQAP has the following materials and services available for use by public health laboratories upon request: (1) amino acid and TSH reference materials for calibration; (2) other special bloodspot materials; and (3) consultation on applications of bloodspot technology, e.g., for measurement of measles antibodies, risk factors for cerebral palsy, and a variety of other conditions. 

Important Links to Learn More About Newborn Screening and Related Topics

Federal agencies

HRSA
NIH/Human Genome

State newborn screening programs (selected programs)

Colorado
Georgia
New England
Michigan
Missouri
New Mexico
New York
North Carolina
Oregon
Texas
Washington
Wisconsin

Private Organizations

American Sickle Cell Anemia Association
Association of Public Health Laboratories
Fatty Oxidation Disorder Family Support Group
Genetic Alliance
Institute of Metabolic Disease, Baylor University
International Society for Neonatal Screening
March of Dimes
National Coalition for PKU and Allied Disorders
National Committee for Clinical Laboratory Standards (NCCLS)
National Newborn Screening & Genetics Resource Center
National Urea Cycle Disorders Foundation
Pediatrix Screening
Save Babies Through Screening

Safe Workplace

Guidelines for Prevention of Transmission of HIV and Hepatitus B Virus to Health-Care Workers

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This page last reviewed August 31, 2004

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