CLSI NBS10

Newborn Screening for Congenital Hypothyroidism, 1st Edition

CLSI NBS10 describes a newborn screening system for detecting congenital hypothyroidism (CH). It discusses both first-tier and second-tier screening tests performed on newborn dried blood spot specimens, as well as screening strategies for identifying newborns at increased risk for CH.

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Chairholder: Ronald J. Whitley, PhD, DABCC, FACB

Date of Publication: April 18, 2024

Order Code PDF: CLSI NBS10Ed1E
ISBN Number: 978-1-68440-223-6

Order Code Print: CLSI NBS10Ed1
ISBN Number: 978-1-68440-222-9

Edition: First

Pages: 104

CLSI NBS10 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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CLSI NBS10 Abstract

Clinical and Laboratory Standards Institute NBS10—Newborn Screening for Congenital Hypothyroidism describes newborn screening (NBS) processes used worldwide to identify newborns at increased risk for congenital hypothyroidism (CH). CH is one of the most common diseases detected by NBS, occurring in as many as 1 in 2000 live births and even more frequently in iodine-deficient areas. Presymptomatic detection through NBS can lead to early diagnosis and treatment, which reduces or eliminates the permanent intellectual disability and growth failure that occurs in individuals with untreated CH. CLSI NBS10 describes the laboratory screening tests for detecting primary CH, as well as the various laboratory screening algorithms in use, including the advantages and disadvantages of each. It also describes other types of CH that may be detected by NBS, such as central, transient, or subclinical CH. CLSI NBS10 is intended for use by health care providers, birthing facilities, NBS laboratories, regulatory agencies, public health policy makers, and manufacturers of instruments, reagents, and related NBS products.