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Laboratory Professionals
National Metrology Institutes, Reference Laboratories, and JCTLM Organizational Members
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Creatinine Standardization Recommendations
National metrology institutes, reference
laboratories, and Joint Committee for Traceability in Laboratory
Medicine (JCTLM) organizational members are crucial partners in the
successful implementation of the Creatinine Standardization Program.
For these groups, the following steps are necessary:
- Provide tools to assist IVD manufacturers with efforts to reduce analytical bias.
- Develop readily available reference materials for serum
creatinine with IDMS-assigned values and with validated commutability
with individual patient sera for a wide variety of routine methods. The
reference materials should be submitted to the JCTLM for review and
acceptance. The National Institute for Standards and Technology (NIST)
released the reference material SRM 967 [two levels, approximately 66
µmol/L (0.75 mg/dL) and 347 µmol/L (3.92 mg/dL)] in 2007.
- Make available a high-level reference measurement procedure
with high throughput to assist in vitro diagnostic manufacturers in
validating the trueness of their methods and the commutability of
candidate reference materials. An LC-IDMS procedure validated to have
little or no bias relative to GC-IDMS may be useful for this purpose.
- Additional reference laboratories are needed to meet the
anticipated demand for analytical services to establish and validate
traceability to the reference method.
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