Isotope dilution mass spectrometry and the National Reference System

Area of Science:

• Clinical chemistry and metrology
• Biomarker standardization
• Laboratory measurement accuracy

Background:

• The U.S. clinical laboratory community relies on accurate reference materials for patient testing.
• The National Institute of Standards and Technology (NIST) develops Isotope Dilution Mass Spectrometry (IDMS) methods and data (DMs).
• These IDMS/DMs serve as the accuracy base for the U.S. National Reference System for serum analytes.

Purpose of the Study:

• To highlight the critical role of NIST's IDMS/DMs in clinical laboratory standardization.
• To emphasize the collaborative efforts between government agencies and professional organizations.
• To underscore the importance of continued investment in IDMS/DM metrology for medical accuracy.

Main Methods:

• Development and maintenance of IDMS/DMs by NIST.
• Value assignments on human serum samples (e.g., Standard Reference Materials).
• Interagency agreements and financial support from NIH, FDA, and CDC.

Main Results:

• NIST's IDMS/DMs provide the accuracy base for U.S. clinical laboratory measurements.
• Collaboration with organizations like AACC and CAP ensures traceability to DMs.
• Accurate patient results are dependent on the availability of IDMS/DM measurements.

Conclusions:

• NIST's IDMS/DM metrology is essential for assuring accurate medical test results.
• Continued R&D and instrumentation are necessary to maintain and upgrade IDMS/DM technology.
• Cooperation between government and private sectors is vital for advancing clinical measurement accuracy.