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About CLSI


CLSI Newborn Screening Standards:

Ensuring Good Health From the Start


Today, virtually all (>99%) of the more than 4 million infants born in the United States each year are screened for conditions such as phenylketonuria, congenital hypothyroidism, galactosemia, and hemoglobinopathies. CLSI’s newborn screening standards provide the critical guidance needed to detect potentially life-threatening and debilitating conditions for better outcomes and healthy, happy infants.

Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition (NBS01-A6)

Newborn Screening Follow-up; Approved Guideline—Second Edition (NBS02-A2)

Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns; Approved Guideline (NBS03-A)

Newborn Screening by Tandem Mass Spectrometry; Approved Guideline (NBS04-A)

Newborn Screening for Cystic Fibrosis; Approved Guideline (NBS05-A)

Newborn Blood Spot Screening for Severe Combined Immunodeficiency by Measurement of T-cell Receptor Excision Circles; Approved Guideline (NBS06-A)

Newborn Screening Specialty Collection (NBSSC)



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