CLSI NBS10
Newborn Screening for Congenital Hypothyroidism
CLSI NBS10 provides guidance to medical laboratories for detecting congenital hypothyrodism (CH) in newborns. 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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{{FormatPrice(nonMemberPrice)}} List PriceClinical 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.
CLSI NBS10 provides recommendations for using dried blood spot (DBS) specimens to perform newborn screening (NBS) for congenital hypothyroidism (CH) and discusses the preanalytical, analytical, and postanalytical aspects of CH NBS. It describes:
• Etiology and clinical manifestations of CH
• Analytical methodologies for thyroid-stimulating hormone (TSH) and total thyroxine (T4)
• Screening strategies and laboratory screening algorithms currently used, including single- or multi-tier testing, that begin with measurements of TSH, total T4, or both
• Variations in TSH and/or total T4 screening strategies, including explanations of the advantages and disadvantages of each strategy
• Successful laboratory practices, including method validation and/or verification, QA, and results interpretation
• Recommendations on implementing CH NBS for emerging programs
The intended users of CLSI NBS10 are NBS laboratories, follow-up and program personnel, birthing facilities, public health program administrators, medical laboratories, pediatric endocrinologists, neonatologists, other health care providers (HCPs), regulatory agencies, public health policy makers, and manufacturers of instruments, reagents, and related NBS products.
CLSI NBS10 does not cover:
• Methodologies for free thyroxine (FT4), thyroglobulin, or point-of-care (POC) testing
• Laboratory testing performed to confirm or exclude a diagnosis (i.e., diagnostic testing)
• Recommendations for diagnosis or treatment of CH
• Comparative cost information
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.
CLSI NBS10 provides recommendations for using dried blood spot (DBS) specimens to perform newborn screening (NBS) for congenital hypothyroidism (CH) and discusses the preanalytical, analytical, and postanalytical aspects of CH NBS. It describes:
• Etiology and clinical manifestations of CH
• Analytical methodologies for thyroid-stimulating hormone (TSH) and total thyroxine (T4)
• Screening strategies and laboratory screening algorithms currently used, including single- or multi-tier testing, that begin with measurements of TSH, total T4, or both
• Variations in TSH and/or total T4 screening strategies, including explanations of the advantages and disadvantages of each strategy
• Successful laboratory practices, including method validation and/or verification, QA, and results interpretation
• Recommendations on implementing CH NBS for emerging programs
The intended users of CLSI NBS10 are NBS laboratories, follow-up and program personnel, birthing facilities, public health program administrators, medical laboratories, pediatric endocrinologists, neonatologists, other health care providers (HCPs), regulatory agencies, public health policy makers, and manufacturers of instruments, reagents, and related NBS products.
CLSI NBS10 does not cover:
• Methodologies for free thyroxine (FT4), thyroglobulin, or point-of-care (POC) testing
• Laboratory testing performed to confirm or exclude a diagnosis (i.e., diagnostic testing)
• Recommendations for diagnosis or treatment of CH
• Comparative cost information