CLSI NBS04
Newborn Screening by Tandem Mass Spectrometry
Discover new approaches to newborn screen through tandem mass spectrometry. CLSI NBS04 elaborates on this effective testing method to ensure life-threatening disorders not evident in birth are detected early and treated efficiently in infants.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2022.
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{{FormatPrice(nonMemberPrice)}} List PriceThis guideline replaces the previous edition of the guideline, NBS04-A, published in 2010. Several changes were made in this edition, including:
• Reorganization to follow the path of workflow
• Updating methodology and references throughout the guideline
• Removing mass spectrometer setup instructions for m/z peak resolution (Subchapter 4.5.4.1) and providing the reference
• Updating terminology throughout the guideline
This guideline is intended to assist newborn screening (NBS) laboratory personnel in the routine use of tandem mass spectrometry (MS/MS) for the detection of metabolites that may indicate certain metabolic disorders using dried blood spot (DBS) specimens. The guideline describes:
• Preparation procedures for reagents, specimens, standards, and controls
• Calibration (both instrument and analyte)
• Standardization
• Control acceptance criteria
• Disorder profiles (interpretation of MS/MS spectra)
• External effects on results (eg, transfusion and total parenteral nutrition [TPN])
• Results reporting
• Second-tier testing
• Follow-up recommendations
This guideline:
• Is not intended to provide general information for screening on all conditions, only screening information related to MS/MS
• Does not cover confirmatory or diagnostic testing
This guideline replaces the previous edition of the guideline, NBS04-A, published in 2010. Several changes were made in this edition, including:
• Reorganization to follow the path of workflow
• Updating methodology and references throughout the guideline
• Removing mass spectrometer setup instructions for m/z peak resolution (Subchapter 4.5.4.1) and providing the reference
• Updating terminology throughout the guideline
This guideline is intended to assist newborn screening (NBS) laboratory personnel in the routine use of tandem mass spectrometry (MS/MS) for the detection of metabolites that may indicate certain metabolic disorders using dried blood spot (DBS) specimens. The guideline describes:
• Preparation procedures for reagents, specimens, standards, and controls
• Calibration (both instrument and analyte)
• Standardization
• Control acceptance criteria
• Disorder profiles (interpretation of MS/MS spectra)
• External effects on results (eg, transfusion and total parenteral nutrition [TPN])
• Results reporting
• Second-tier testing
• Follow-up recommendations
This guideline:
• Is not intended to provide general information for screening on all conditions, only screening information related to MS/MS
• Does not cover confirmatory or diagnostic testing