CLSI I/LA32 P : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
07-27-2010
01-12-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 General Considerations
5 Disorders Detected by Tandem Mass Spectrometry
6 Reagents, Internal Standards, Plate and Plate Covers,
and Specimen Preparation
7 Mass Spectrometer Calibration and Verification
8 Instrument Operation
9 Method Validation
10 Establishing and Validating Cutoffs
11 Quality Assurance
12 Proficiency Testing
13 Result (Run) Acceptance Criteria
14 Result Reporting and Interpretation
15 External Factors Affecting Results
16 Follow-Up (Short-Term) Activities
17 Additional assays
References
Appendix A - In-House Control Preparation
Appendix B - Scan Speed Considerations
Appendix C - Maintenance
Appendix D - Tubing Considerations
Appendix E - Flow Path Blockages
Appendix F - Troubleshooting Guides
Appendix G - Ion Comparison
Appendix H - Chemical Structures
The Quality Management System Approach
Related ClSI Reference Materials
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