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CLSI Publishes Newborn Screening Document NBS03—Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition


Wayne, Pennsylvania, USAThe Clinical and Laboratory Standards Institute (CLSI) has published NBS03—Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns. NBS03 describes newborn screening (NBS) of preterm, low birth weight (LBW), and sick newborns worldwide to detect treatable diseases before physical damage can occur. In developed countries, treatment advances have improved survival rates, making early disease detection by NBS even more important. The physiological states associated with preterm, LBW, and sick newborns and the treatments received directly affect the reliability of results for many diseases screened in public health by newborn dried blood spot screening, newborn hearing screening, and critical congenital heart disease (CCHD) screening. This guideline describes the effects of maternal and newborn conditions, as well as treatments given to newborns, that may affect NBS results. This guideline also provides the rationale for recommended screening intervals designed to minimize the risk of missing or delaying a diagnosis in an affected newborn. This guideline is intended for use by those involved in any aspect of NBS specimen collection, hearing screening, CCHD screening, and follow-up, including health care providers, public health professionals, and others concerned with newborn health and welfare.

Julie Luedtke, Chairholder of NBS03, said, “Annually worldwide millions of newborns are born prematurely, of low birth weight, or with serious birth defects. The effects of these conditions, and the treatments these newborns receive greatly complicate the ability to obtain reliable and timely newborn screening results for the dozens of diseases screened. The new revision of NBS03 hones in on these complications and the new tables more succinctly describe the factors affecting newborn screening test results for this population.”

For more information about NBS03, contact Patrick McGinn at pmcginn@clsi.org or +1.484.588.5933.       

CLSI sets the standard for quality in medical laboratory testing. A not-for-profit membership organization, CLSI brings together the global laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine.    

For over 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery, and improve health care around the world.     

By using CLSI standards, laboratorians can improve process quality, speed the development of standard operating procedures, and implement safer practices with greater ease and efficiency.


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