Newborn Screening Specimen Collection (LA4-A5); Verification and Validation of Multiplex Nucleic Acid Assays (MM17-P)

CLSI Publishes Standard for Newborn Screening Specimen Collection
Wayne, Pennsylvania, USA—August 2007— In all newborn screening programs, the turnaround time for analytic results is critical for prompt diagnosis and treatment. The new edition of Clinical and Laboratory Standards Institute’s (CLSI) document titled Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Fifth Edition (LA4-A5) addresses the issues associated with specimen collection, the filter paper collection device, and the transfer of blood onto filter paper, and provides uniform techniques for collecting the best possible specimen for use in newborn screening programs.
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New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex Nucleic Acid Assays
Wayne, Pennsylvania, USA—August 2007—Multiplex assays detect the presence of and discriminate two or more analytes simultaneously in the same sample. The number of commercially available multiplex assays is increasing rapidly, as is the number of laboratory-developed multiplex assays, and these use a variety of technologies and instrument platforms. Multiplex testing provides significant challenges to the laboratory with regards to appropriate verification and validation testing, and especially the acquisition of appropriate control and reference materials to conduct the testing.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Verification and Validation of Multiplex Nucleic Acid Assays; Proposed Guideline (MM17-P), which provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.
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