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YY/T 0638-2008: In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
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In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
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YY/T 0638-2008
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Basic data | Standard ID | YY/T 0638-2008 (YY/T0638-2008) | | Description (Translated English) | In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100 | | Word Count Estimation | 14,167 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Quoted Standard | GB/T 21415-2008 | | Adopted Standard | ISO 18153-2003, IDT | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies ensure enzymatic concentration calibration and control materials Metrological traceability assignment methods. These calibration and control materials are expected to be used to establish or verify the enzymatic concentration measurement accuracy, provided by the manufacturer as part of in vitro diagnostic medical devices or their combination. This standard does not apply to: a) reference measurement procedures for the design or selection requirements, b) the quality of the enzyme or enzymes involved in the immune response of the amount, c) No assignment, only the measurement procedures used to evaluate the accuracy, ie repetitive or heavy now of controlled substances (precision controlled substances), d) intended for internal quality control of controlled substances, such substances have suggested an acceptable result value range, this range by a different laboratory procedures for a specified measurement protocol developed, does not have its limits Metrological traceability, e) regular calibration result to the product Metrological traceability of products, and its relationship with the medical judgment limit, f) with nominal and ordinal scale related features. | YY/T 0638-2008: In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
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In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
ICS 11.100
C30
People's Republic of China pharmaceutical industry standards
YY/T 0638-2008/ISO 18153.2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples
Calibration and control materials in enzymatic concentration assignment
Metrological traceability
(ISO 18153.2003, IDT)
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is identical with ISO 18153.2003 "in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials
Enzymatic concentration assignment metrological traceability. "
For ease of use, this standard made the following editorial changes.
--- "This International Standard" be replaced by "this standard";
"." --- With a decimal point instead of a comma as the decimal point, "";
--- Delete international standards foreword.
The Standard Appendix A, Appendix B is an informative annex.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Roche Diagnostics (Shanghai) Co., Ltd.
The main drafters of this standard. Hu Dongmei, Pingren Feng, Huang Boxing, Zhang Xinmei, Wangrui Xia, He Xueying.
YY/T 0638-2008/ISO 18153.2003
Introduction
Vitro Diagnostic Medical Devices Directive 98/79/EC requirements, assignment calibrators and control materials, need to be obtained through a higher level of participation
Measurement test substance and reference measurement procedures to ensure that its metrological traceability. According to this concept of "traceability" standard GB/T 21415
The measurement procedures and calibration traceable grade material has been described in detail. General The standard also applies to the amount of catalytic activity. Should do
May be on the measurement traceable to SI units, namely, the most advanced level of alignment.
This standard catalytic activity of the enzyme concentration (hereinafter referred to as "catalyst concentration") level measurement of calibrators and measurement procedures are described. Enzyme
Science measurement, always export the SI unit is defined as "Moore cubic meters per second [mol/(s · m3)]", General Conference on Weights and Measures will be named "Keita
Seoul per cubic meter (katal/m3) ", is the most senior levels of traceability, followed by a reference measurement procedure, other lower-level measurement procedures, calibration
Controlled substances and products should be traceable as possible to the program.
Catalytic concentration measurements in blood or other biological fluids enzymes contribute to the diagnosis of the disease. Enzymatic analysis principle to measure substrate conversion catalyst
Of the rate, high speed, low detection limits, analysis of high specificity and low cost. Only catalytic measured under the same conditions of concentration
Value was comparable. Therefore, the enzyme is measured will be described, not only the amount of type (such as catalytic concentration), and enzyme systems
Name, and the need to include specific measurement procedures, especially in the measurement of the reaction indicating element. In the calibration level vertex, measurement procedures
It should be internationally recognized, such as "creatine kinase (CK) of the IFCC reference measurement procedure to measure NADH conversion rate CK".
Thus, the primary reference measurement procedure is defined measured integral part, must strictly follow all the details, for example, include the following
content.
--- Species of the substrate (specific decision by the enzyme, may be different) and their concentrations;
--- Activator and concentration;
--- Catalytic reaction direction;
--- Indicating element;
--- Buffer system and pH;
---temperature;
--- Pre-heating time;
--- Responsive promoter substance;
---delay;
---Reaction time.
Definition of enzyme to be measured and the measurement results of the resulting reliance on the program, this defect is known. In the EQA
(EQA) and the method may occur metastatic evaluation problem; there was diversity of biological reference intervals, thereby causing enzyme results of clinical error
With risk. Conventional enzyme standardized measure of laboratory medicine is very important, by eliminating differences existing biological reference intervals, clinical improvement
Applications and comparability of results.
It can be considered in two ways.
a) General recommendation applies only to each enzyme or standardized measurement procedures;
Interchangeable enzyme calibration material b) by using the selected reference measurement procedure assignment of one or more conventional measurement procedures
calibration.
Method (a) "Referral Program" has been continuing the pursuit of more than 20 years. Improving quality levels and enzyme measurement and comparability of discouraging the use of analysis
Unsatisfactory aspects of the program has made great achievements. However, the recommended method of procedure standardized approach has reached its limit. its
The disadvantage is that. the lack of consensus on a number of recommended programs selected, during routine use of the procedure recommended by intentional or unintentional changes recommended
Procedures for the analysis and the lack of response to technological advances, the recommended procedure for a degree of automation is not suitable. Conventional enzyme measurement procedure
Change, regardless of whether the recommended program will change the biological reference value, clinicians necessarily easy to accept.
YY/T 0638-2008/ISO 18153.2003
Improved design and analysis of performance measurement enzymes will also will be endless. However, this process should follow the scientific progress and the development of P
And rules. Further attempts to develop and encourage the use of unified standardized procedures, is neither practical nor meet the need.
Corresponding, the method (b) "reference measurement procedures and calibration material" does not get enough attention. Objection included.
1. Lack of a stable enzyme with a suitable matrix reference materials as calibrators.
2. Candidate enzyme calibrators differ from the analyte in the sample body enzymes, including differences in the isozyme.
3. Enzyme Calibrator and patient samples containing the analyte enzyme in the calibration (reference) program and the lack of a stable alignment between the (conventional) program
The ratio between programs (ie, the lack of interchangeability).
From these problems, we recommend calibration of a higher level of enzyme reference materials and measurement procedures both put forward a series of demands. Calibrator
Should be stable, containing the analyte enzyme catalytic properties in its matrix should be routine sample analysis and catalytic properties of enzyme proximity; measurement procedures since
Body for the catalytic activity of a target enzyme, should have the same specificity.
Thus, for each enzyme has important clinical significance, you can select a reference measurement procedures and identification of a series of related procedures to achieve
Conventional enzyme measurement results comparable. The results of any of a series of procedures that can be traced on metrology to the selected reference measurement
program.
YY/T 0638-2008/ISO 18153.2003
In vitro diagnostic medical devices - Measurement of quantities in biological samples
Calibration and control materials in enzymatic concentration assignment
Metrological traceability
1 Scope
This standard specifies ensure calibrators and measurement of controlled substances assigned enzymatic concentration methodological traceability. These calibrators and controls
Substance is expected to be used to establish or verify the accuracy of measuring the concentration of enzyme catalysis, provided by the manufacturer, as part of in vitro diagnostic medical device or
In combination therewith.
This standard does not apply to.
a) the reference measurement procedures designed or selected requirements;
b) the amount of enzyme or enzyme immunoassay of quality involved;
c) no assignment is only used to evaluate the precision of the measurement program, namely the repeatability or reproducibility of controlled substances (precision control materials);
d) controlled substances intended for internal quality control, the results of such substances acceptable range of values has recommended this interval by different
Laboratory measurement procedures for the agreement to establish a provision, which limits non-metrological traceability;
e) the results of the conventional measurement products calibrator traceability of its relationship with the medical judgment of the limit;
f) nominal and ordinal scale related features.
2 Normative references
The following documents contain provisions which, through reference in this standard, constitute provisions of the standard. For dated references, subsequently
Some amendments or revisions do not apply to this standard, however, whether these files can be used to encourage the parties in accordance with this standard agreement
The latest version. For undated reference documents, the latest versions apply to this standard (including amendments).
GB/T 21415-2008 vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrology
Traceability (ISO 17511.2003, IDT)
International Fundamentals and vocabulary generic term measurement (VIM), 2nd edition, Geneva. ISO , 19931)
Guide to the Expression of Uncertainty in Measurement, first edition, Geneva. ISO , 19932) 3)
1) In this standard abbreviations VIM.1993.
2) This publication is a joint working group of experts established by the agency assigned the following. BIMP International Bureau of Weights and Measures, IEC International Electrotechnical Commission,
IFCC International Federation of Clinical Chemistry and Laboratory Medicine, ISO International Standards Organization, IUPAC International Union Pure and Applied Chemistry, IUPAP International Li
Theory and Applications of Physics, OIML International Organization of Legal Metrology.
3) the use of abbreviations in this standard GUM.1993.
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Name measure illustrated components.
[ISO 17511.2003,3.2]
Example. In the "plasma concentration of lactate dehydrogenase isozymes catalyze 1", the "lactate dehydrogenase isoenzyme 1" is the analyte. "Plasma lactate dehydrogenase isoenzyme 1
The catalytic concentration "represents the measurement, see 3.5.
YY/T 0638-2008/ISO 18153.2003
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