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JCTLM Database: higher-order reference materials, methods and services
Details : C9RMS12 - alpha-amylase in Blood serum, Blood plasma
| Type (acronym) | rms |
|---|---|
| Type | reference measurement service |
| Unique Nomination Number | C9RMS12 |
| Reference Laboratory Status | Manufacturer |
| Analyte Name | alpha-amylase |
| IUPAC IFCC Number | EC 3.2.1.1 |
| Applicable Matrices | lyophilized blood serum, or plasma |
| Traceable to SI | Yes |
| Principle of Analytical Procedure | Kinetic spectrophotometry |
| Reference Method Listed in JCTLM | Yes |
| Name of JCTLM Listed Reference Method Procedure | IFCC reference measurement procedure (37 °C) for amylase |
| JCTLM Database Identifier Number | NRMeth 70 |
| Procedure Difference in Your Laboratory | No |
| Quantity | Catalytic activity concentration |
| From (0) | 1.15 |
| To (0) | 12.52 |
| Unit (0) | µkat/l |
| From (1) | 2.7 |
| To (1) | 2.7 |
| Unit (1) | % |
| Level of Confidence (%) | 95% |
| Comments on Concentration Range | The conversion factor for enzyme catalytic activity concentrations: 1 U/L = 0.01667 µkat/L.
The range of concentration is within the concentrations measured without dilution of the sample.
|
| Comments on Uncertainty Range | The expanded uncertainty is a relative uncertainty. |
| Reference Procedure Status Acceptable | The reported (accredited) measuring range for AMY and LDH is significantly narrow, if compared with the original IFCC reference procedures. The accreditation body (here CNAS) has not certified the upper limits of the measuring ranges which are expected with measurements according to the IFCC reference measurement procedure. The issue of new certificates might be a formal action or requires additional experiments. However, a decision on this has to be made by the accreditation experts sitting in the JCTLM Executive, |
| Laboratory Status | (b) |
| Survey Organisation | RELA - IFCC External Quality assessment scheme for Reference Laboratories in Laboratory Medicine |
| Intercomparison Results Publicly Available | Yes |
| 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 |
| Participation Status in Intercomparison Surveys acceptable | YES |
| Comments of Review Teams | The frequency of measurements was not reported on the excel worksheet. |
| Organization Acronym | Maccura |
| Organization Name | Maccura Biotechnology Co., Ltd. Reference System Dept. |
| Organization Website | https://www.maccura.com/en/ |
| Organization Country ISO Code | CN |
| Organization Country Name | China |
| Analyte Category Name | Enzymes |