Specialty Areas

Newborn Screening

Setting the Standard

Setting the Global Standard for Newborn Screenings

Early detection, diagnosis, and treatment of newborn diseases are critically important. Timely newborn screening can prevent death and significantly improve patient care outcomes by ensuring infants with serious metabolic and hereditary disorders are identified as early as possible.

CLSI Newborn Screening (NBS) laboratory standards support screening programs worldwide by providing clear test collection instructions and guidance on methods used to detect a wide range of metabolic and hereditary conditions. These standards help promote consistency, accuracy, and reliability across the newborn screening continuum, from specimen collection through testing and follow‑up.

All CLSI NBS standards are developed through CLSI’s internationally recognized, consensus‑based process. This collaborative approach brings together experts from public health, clinical laboratories, industry, and government to develop practical, unbiased guidance that reflects current science, real‑world practice, and the evolving needs of newborn screening programs worldwide.

Expertise

A Community of Experts
in Newborn Screening

CLSI is globally recognized for its rigorous, consensus‑driven development of NBS standards and guidance. These resources address critical aspects of newborn screening, including specimen collection, testing practices, and quality considerations. CLSI’s NBS activities are supported by expert contributors from newborn screening laboratories, public health programs, government organizations, and the screening and diagnostics industry, ensuring guidance reflects broad expertise and real‑world experience.

Newborn Screening Standards

The Gold Standard for NBS

CLSI’s Newborn Screening standards define critical performance expectations and best practices that support accurate, high‑quality newborn screening. CLSI offers NBS testing standards for cystic fibrosis, hemoglobinopathies, congenital hypothyroidism, and more.

Other Newborn Screening Resources

Critical Resources for Newborn Screening

CLSI’s Newborn Screening resources define essential quality requirements and best practices to support reliable screening programs. Making a Difference Through Newborn Screening: Blood Collection on Filter Paper (NBS01‑Ed7) features a brief video demonstrating best practices based on CLSI’s NBS01 document.

Latest Newborn Screening Insights

Newborn Screening
As newborn screening expands, consistency becomes more critical than ever. Explore how guidance supports accurate detection and better outcomes for conditions like SCID.
Newborn Screening
We spoke with Dr. Bradford Therrell, an expert in newborn screening and an author for CLSI NBS01 about the importance of newborn screening and it's global impact.
Newborn Screening
Learn about the treatment of newborns with Phenylketonuria, also called PKU, a rare inherited disorder.
Get Involved

Share Your Expertise

Join our community of industry leaders who volunteer their experience and knowledge to drive innovation and excellence in laboratory practices.

Newborn Screening Projects in Progress

Please note, the publication dates are subject to change based on document development activities.

Loading...

Sign Up for our Newsletter

You'll receive the latest updates on new standards, guidelines, and educational resources, as well as expert insights to help enhance your laboratory's performance and compliance.