JCTLMJoint Committee for Traceability in Laboratory Medicine
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For example, the JCTLM maintains a database of reference measurement procedures, reference materials, and reference measurement laboratories certified against appropriate ISO standards.
The C-peptide committee agreed that it was important to move forward with harmonization, and the manufacturers agreed that the candidate reference measurement procedure should be internationally recognized by being listed in the JCTLM database.
C-peptide was chosen as the material for the comparison for several reasons: It was a model system for mass fraction assignments of straight chain peptides with molar mass of <5000 g/mol; CRMs for C-peptide and reference measurement procedures for C-peptide measurement were already being provided by at least 1 NMI [National Metrology Institute of Japan (NMIJ)] and listed in the JCTLM database; and the material would be available in sufficiently large quantities for it to be value-assigned by independent methods by the BIPM and NMIs, notably by mass balance, amino acid analysis corrected for peptide impurities, and quantitative nuclear magnetic resonance corrected for peptide impurity content.
The JCTLM is a project of the International Bureau of Pounds and Measures (BIPM), and is composed of representatives from BIPM, IFCC, and the International Laboratory Accreditation Cooperation (ILAC).
The JCTLM maintains a searchable database of certified reference materials, accepted reference methods, and standardization organizations, available at this address: http://www.bipm.org/jctlm/.
When this new standard is completed and published, harmonization protocols that conform to the standard can be listed by JCTLM to enable their use by manufacturers of MPs to achieve harmonized results among different MPs for the same measurand.
[2] Nonstandard abbreviations: MP, measurement procedure; FDA, Food and Drug Administration; CRM, Certified Reference Material; RMP; reference measurement procedure; EU, European Union; ISO, International Organization for Standardization; JCTLM, Joint Committee for Traceability in Laboratory Medicine.
[1] Nonstandard abbreviations: RMP, reference measurement procedure; IS, internal standard; JCTLM, Joint Committee for Traceability in Laboratory Medicine.
We evaluated the accuracy of the method through comparison of 40 individual serum samples with values assigned by the candidate RMP to value assignments by 2 JCTLM-recognized reference methods (31): NIST (JCTLM code C4RMP2) and University of Ghent (JCTLM code NRMeth 7).
Calibrations of the LC-IDMS DCMP and the commercial measurement procedures were verified to be traceable to Joint Committee for Traceability in Laboratory Medicine (JCTLM) listed reference measurement procedures and reference materials.
For example, the IFCC and the Joint Committee for Traceability in Laboratory Medicine (JCTLM) have promoted international implementation of traceability in these categories (4, 5).
Mean target values were 26.7 [micro]mol/L (95% CI, 26.1-27.3 [micro]mol/L) and 68.7 [micro]mol/L (95% CI, 67.2-70.2 [micro]mol/L), as assigned with the Doumas reference measurement procedure (1-3) in the Joint Committee for Traceability in Laboratory Medicine (JCTLM)listed reference laboratory in Hanover, Germany.