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JCTLM Database: higher-order reference materials, methods and services
Details : C13RMS17 - HbA1c in Whole blood
| Type (acronym) | rms |
|---|---|
| Type | reference measurement service |
| Unique Nomination Number | C13RMS17 |
| Reference Laboratory Status | Reference material producer&supplier |
| Analyte Name | HbA1c |
| IUPAC IFCC Number | QU60433 |
| Traceable to SI | Yes |
| Principle of Analytical Procedure | Hemoglobin samples treated with endoproteinase Glu-C followed by HPLC and electrospray ionisation mass spectrometry (ESI-MS) |
| Reference Method Listed in JCTLM | Yes |
| Name of JCTLM Listed Reference Method Procedure | IFCC method for HbA1c (HPLC / MS-ESI) |
| JCTLM Database Identifier Number | C1RMP_P16_MS |
| Procedure Difference in Your Laboratory | No |
| Quantity | Amount-of-substance fraction |
| From (0) | 20 |
| To (0) | 140 |
| Unit (0) | mmol/mol |
| From (1) | 0.5 |
| To (1) | 3 |
| Unit (1) | mmol/mol |
| Level of Confidence (%) | 95% |
| Comments on Uncertainty Range | The expanded uncertainty calculated according to GUM |
| Reference Procedure Status Acceptable | Only after appropriate modification |
| Laboratory Status | accredited ISO17025 and 15195 |
| Survey Organisation | RELA |
| Intercomparison Results Publicly Available | Yes (2014,2015) 2017 will be available |
| Link to Comparison Results | RELA - IFCC External Quality assessment scheme for Reference Laboratories in Laboratory Medicine at AND http://www.dgkl-rfb.de:81/index.shtml |
| Reference to Published Comparison Results | The code of this laboratory in RELA - IFCC EQAS is 19 |
| Participation Status in Intercomparison Surveys acceptable | Y |
| Comments of Review Teams | The RELA results from 2017 are acceptable and the documents provided are sufficient to demonstrate the laboratory competence. However before listing on the data base, the review team recommends addressing few changes: 1. operative ranges and listed uncertainties should match the accreditation values. 2. name of the analyte is HbA1c. 3. please define the quantity as an amount of substance fraction. Appropriate resposne was provided by ReCCs on 14 MArch 2019 |
| Organization Acronym | ReCCS |
| Organization Name | Reference Material Institute for Clinical Chemistry Standards |
| Organization Website | http://www.reccs.or.jp/ |
| Organization Country ISO Code | JP |
| Organization Country Name | Japan |
| Analyte Category Name | Proteins |