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CLSI Publishes Updated Standard on Newborn Screening Blood Collection on Filter Paper

Wayne, Pennsylvania, USA—August 2013—The Clinical and Laboratory Standards Institute (CLSI) has released an updated edition of its standard NBS01-A6 (replaces LA04-A5)—Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition. This important document, revised for the first time since 2007, contains a substantial amount of new information and insight for personnel on the essentials of correctly collecting a high-quality specimen, handling the specimen after it has been collected, transporting it to the testing facility, and sorting the residual specimen that remains after laboratory testing.

The primary goal of this standard is to improve and ensure the quality of blood spots collected from newborns to allow for proper newborn screening (NBS). NBS01-A6, which highlights specimen collection and the use of a specimen collection device (card), is intended for use by hospital personnel, midwives, or other health care workers who collect specimens for NBS during the first days of a newborn’s life.

W. Harry Hannon, PhD, chairholder of the NBS01-A6 document development committee, noted that, “The updating of NBS01-A6 is critical; it is the core document of the CLSI Newborn Screening Library and without high-quality blood spots, one cannot expect quality performance for any assay.”

Highlights of NBS01-A6 include procedures for applying blood that was collected by different techniques in the preprinted circles (targets) on the specimen collection device (card) and collection of blood with transfer devices. The standard outlines the analysis of poor-quality and less-than-ideal specimens, addresses interfering substances, and provides recommendations on the sources of blood. NBS01-A6 also recommends pain management strategies for newborns during skin puncture and describes minimal and optional information to capture with the collected specimen.

This edition of NBS01 was a global effort, with input from volunteers from more than 11 countries to ensure that the document targets the global NBS community. Due to the global participation during this revision, NBS01-A6 received endorsement from the International Neonatal Screening Society.

The appendixes were updated and improved, and some are available in laminated format for use as instructional aids. An updated instructional DVD consistent with the new content in NBS01-A6 will be available in late 2013.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call 610.688.0100.



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