Reference Materials and Duty of ReCCS
Definition of reference materials
A reference material is a substance which calibration of a measuring device, evaluation of a measuring method, or one or more characteristic values (concentration) for use in assigning a value are appropriately determined.
A certified reference material is a reference material which one or more characteristic values are provided by metrological relevant procedure with a certificate where characteristic values, their uncertainties and metrological traceability are described.
The reference materials can be divided into two classifications. One is a pure substance system reference material, called primary reference material, the other is a standard material having the same composition as the biological sample for example serum and blood. In other words, it is a standard material of biological origin, which is required especially in the field of clinical examination, hereafter named a biological matrix-based certified reference material.
Usually, primary reference materials are often used as national measurement standards. In the field of clinical examination which requires easy-to-use approach, quickness and precision, biological matrix-based certified reference materials are preferred. When a biological matrix-based certified reference material is used, a traceability can be secured in the case of the existence of a standard measurement method that connects the biological matrix-based certified reference material and the primary reference material. This is the reason why the biological matrix-based certified reference materials are used for the accuracy management of the routine test methods.
In the field of clinical examination, from the highest in the traceability system, reference materials are distinguished as follows: primary reference materials (including national measurement standard reference materials, etc.), reference measurement standards, working measurement standards, calibrators, or controls. Reference measurement standard materials are used as a direct criteria of the of the routine method’s accuracy. The reference measurement standard should be the same as the samples used for actual measurement.
Duty of ReCCS
- Internationally Certified Reference Laboratory in Laboratory Medicine:
- Supplying institute of reference materials:
- Role to traceability system:
- Collaboration with academic organizations and institutions both internationally and domestically:
- Ministry of Health, Labor and Welfare / In vitro diagnostic standards for calibration:
Features of reference materials of ReCCS
Reference Materials of ReCCS are to be used for the purposes described below;
- Calibration of routine method
- Evaluation of precision of routine method
(manufacturer for in vitro diagnostic medicine products and medical institutions) - Criteria for determining the calibrator and control values of the routine method
- Evaluation of accuracy of new developed and improved routine method
- Calibration materials for manufacturing and sales of in vitro diagnostic medicine products to the Ministry of Health, Labor and Welfare
- Criteria of target values for internal quality control and external quality control
- Securing traceability by ISO 15189
- ■Main standard substance provided by ReCCS
- Glycated Hemoglobin (Hemoglobin A1c)
- Glucose
- Cholesterol (Total Cholesterol, HDL Cholesterol, LDL Cholesterol), Total Glycerides, Free Glycerol
- Electrolytes (Na, K, Cl, total Ca, total Mg)
- Creatinine, Urea Nitrogen, Uric Acid
- Serum Iron
- Inorganic Phosphorus
- Total Hemoglobin
- CRP (C-reactive protein)
- Glycated Albumin
- Albumin
- Blood Gas
- JSCC Enzymes (Multi-Enzymes, Cholinesterase)
- IFCC Standards
- Dialysis Solutions
- Others
Use of Reference Materials
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Internationally Certified Reference Laboratory in Laboratory Medicine:
ReCCS (Reference Material Institute for Clinical Chemistry Standards) is certified as a reference laboratory in the list of JCTLM (Joint Committee on Traceability in Laboratory Medicine) regarding cholesterol, HbA1c, etc., and plays a duty of primary reference laboratory in Laboratory Medicine in Japan.
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Supplying institute of reference materials:
- ReCCS is providing reference materials by the international standards applied by MRA (Mutual Recognition Agreement), such as Certified Reference Material for Measurement of HbA1c (JCCRM 411), HDL and LDL Cholesterol (JCCRM 224), Total Cholesterol (JCCRM 211), and Creatinine (JCCRM 521).
- As higher-order reference materials registered by JCTLM (The Joint Committee for Traceability in Laboratory Medicine), ReCCS is providing the Certified Reference Materials for HbA1c (JDS HbA1c Lot 2), Triglycerides (JCCRM 223), Cholesterol (JCCRM 211), Electrolytes (JCCRM111).
- ReCCS has obtained three major ISO certifications for the first time in Japan, ISO 15195, ISO/IEC 17025 and ISO Guide 34 for lipids which include Total Cholesterol, Total Glycerides, HDL cholesterol and LDL cholesterol, as well as HbA1c and Creatinine.
- ReCCS is an organization who certifies and provide the reference materials for using in the field of clinical examination such as primary measurement standards, reference measurement standards and biological matrix-based certified reference materials.
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Role to traceability system:
As most of the reference measurement standards of ReCCS are based on biological samples their certified values are not easily affected even in the presence of coexistence of other ingredients, and these certified values are measured using isotope dilution mass spectrometry (ID/MS). Some of the reference measurement standards are determined by other reference methods, but these are methods, certified as reference methods by the academic societies in Japan.
Also, as for the reference measurement standard is most important to secure the traceability system, we are checking the bias between several routine methods. -
Collaboration with academic organizations and institutions both internationally and domestically:
In recent years, ensuring the traceability of the values, measured by certified reference materials has become indispensable because of the expanding acquisition of ISO 15189, rapid progress of international standardization, and securing the reliability of the laboratory test results. Japanese Association of Medical Technologists has proceeded accuracy management projects of the laboratory test results using certified standard reference materials which have been provided from ReCCS. (Also reference materials of IRMM have been used.)
The biological matrix-based primary reference materials of ReCCS have acquired MRA and their values are internationally acceptable. Manufacturers that provide reference materials in new fields are increasing both internationally and domestically.
The importance of international reference materials, which have acquired MRA, is increasing because the consistency with values of the overseas manufacturers’ reference materials is indispensable.
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Ministry of Health, Labor and Welfare / In vitro diagnostic standards for calibration:
In order to confirm performance of in vitro diagnostic standards according to the standards of in vitro diagnostic medicine by the Ministry of Health, Labor and Welfare by the Article 41, Paragraph 3 of the Pharmaceuticals Affairs Law related to ensure the quality, effectiveness and safety, ReCCS is supplying certified standard reference materials.
(It is said that when the performance of the in vitro diagnostic medicine products depends on the use of the calibrator or the reference materials, retroactivity of values which was assigned to them must be guaranteed using available standard measuring methods or higher-order reference materials.)
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Glycated Hemoglobin (Hemoglobin A1c)
JCCRM 411(JDS Lot5), Certified Reference Material for Measurement of HbA1c (Frozen Liquid)
JCCRM 411 is primary intended to use in the calibration of routine methods (HPLC, Immunoassays, Enzymatic methods, etc.) and Centrifugation POCT. IFCC(mmol/mol), NGSP(%), and JDS numbers(%) are certified. These values are consistent with IFCC-NGSP and NGSP-JDS Master Equations published by IFCC HbA1c WG.JCCRM 423, Certified reference Material for Measurement of HbA1c (Lyophilized)
JCCRM 423 is a hemoglobin-based primary reference material for HbA1c measurement, traceable to JCCRM 411 (JDS Lot 5 ), primary intended to use in the 3 point check over the calibration curve, whereas 5 points check are given by a higher-order reference materials (JDS Lot 5, JDS Lot 2), stabilized working reference material in accordance with JDS Lot 5. NGSP numbers are used in clinical practice in Japan. Lyophilized material, available to store in a freezer -20℃. Measured by KO500 method of JSCC/JDS specified comparison method.JCCRM 400, Certified Reference Material for Measurement of HbA1c (Frozen Liquid)
JDS HbA1c Lot 2 which was prepared in 2001 and has been stored in liquid nitrogen for 13 years, is traceable to SI units, its JDS HbA1c value was certified by the Committee on Standardization of Laboratory Testing of the Japan Diabetes Society (JDS). This is higher-order reference material for HbA1c measurement, intended to be used for validation of securing traceability of working, or secondary reference materials. IFCC values are determined by 11 IFCC HbA1c Network Laboratories, over 17 years ago. NGSP and JDS values are also assigned. -
Glucose
JCCRM 523, Certified Reference Material for Measurement of Glucose (Frozen Liquid)
JCCRM 523 was determined the certified value for glucose concentration using Deproteinization treatment hexokinase/G-6-PD method by ReCCS. The main purpose of use is confirmation of the accuracy of serum glucose concentration values by the enzyme electrode method of routine measurement and enzyme methods such as hexokinase/G-6-PD method. -
Cholesterol (Total Cholesterol, HDL Cholesterol, LDL Cholesterol), Total Glycerides, Free Glycerol
JCCRM 211, Certified Reference Material for Measurement of Total Cholesterol and Glycerides in Human Serum (Frozen Liquid)
JCCRM 211 is intended to use in evaluating the accuracy of Total Cholesterol, Total Glycerides and Triglycerides measurement, validating secondary reference materials. Total Cholesterol is internationally standardized by the CDC reference method, modified Abell-Kendall(AK) method by CRMLN. Reference values by AK are shown in our certificate compared with those by ID/MS method. Calibrate the routine method and confirmation of accuracy.
Available to use as a reference standard for the international comparison of measured values.JCCRM 223, Certified Reference Material for Measurement of Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides and Total Glycerides in Human Serum (Frozen Liquid)
JCCRM 223 is intended to use in evaluating the accuracy of clinical procedures for the determination of Total Cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides. LDL-C value determined by CDC reference method is also assigned for the comparison with LDL-C value by Friedewald equation. LDL-C value determined by CDC reference method is also assigned for comparison with LDL-C value by Friedewald equation.JCCRM 224, Certified Reference Material for Measurement of HDL cholesterol, LDL cholesterol and Triglycerides in Human Serum (Frozen Liquid)
JCCRM 224 is intended to use in evaluating the harmonization of clinical procedures for the determination of HDL cholesterol and LDL cholesterol. HDL-C and LDL-C were assayed by the CDC reference methods. -
Electrolytes (Na, K, Cl, total Ca, total Mg)
JCCRM 321, Certified Reference Material for Measurement of Electrolytes in Human Serum (Frozen Liquid)
JCCRM 321, secondary reference material for Na, K, Cl, TCa, TMg, IP is intended to use for the calibration of routine Iron Selective Electrode analyzers measuring Na, K, and Cl in blood serum using ISE in clinical testing.JCCRM 111, Certified Reference Material for Ion Selective Electrode (Frozen Liquid)
JCCRM 111 is intended to use for evaluating the accuracy of serum(plasma) Na, K and Cl measurements with iron selective electrodes in clinical laboratory tests. This CRM is a higher-order reference material for ion electrodes, Na and K are assayed by the NIST defective methods, Cl agrees with that of IDD-ICP/MS.JCTCM 130, Trueness Control Material for Iron-Selective Electrode (Liquid)
JCTCM 130 is intended to use for the calibration of ISE analyzers measuring Na, K and Cl in blood serum using ion-selective electrode in clinical testing. Using glass ampoule, available to keep in the refrigerator.JCTCM 131, Trueness Control Material for Ion-Selective Electrode (Liquid)
JCTCM 131 is intended to use for the calibration of ISE analyzers measuring Na, K and Cl in blood serum using ion-selective electrode in clinical testing. Using glass ampoule, available to keep in the refrigerator. -
Creatinine, Urea Nitrogen, Uric Acid
JCCRM 521, Certified Reference Material for Measurement of Glucose, Creatinine, Uric Acid and Urea-Nitrogen in Human Serum (Frozen Liquid)
JCCRM 521 is for creatinine, uric acid and urea nitrogen measurement, intended to use for calibrating and evaluating the accuracy of routine methods, the internal and external quality of measurement and validating working reference materials. Creatinine was assayed by isotope dilution mass spectrometry, Glucose, uric and uric nitrogen were assayed by JSCC reference method. -
Serum Iron
JCCRM 322, Certified Reference Material for Measurement of Serum Iron (Frozen Liquid)
JCCRM 322 is intended to use for evaluating the accuracy of procedures and calibrating procedures for determination of serum iron. -
Inorganic Phosphorus
JCCRM 324, Certified Reference Material for Measurement of Inorganic Phosphorus (Frozen Liquid)
JJCCRM 324 is intended to use for evaluating the accuracy of procedures and calibrating procedures for determination of inorganic phosphorus. 6 vials, 2 vials for each of 3 levels(L, M, H), each vial contains 1.0 mL (25,000 JPY). -
Total Hemoglobin
JCCRM 912, Certified Reference Material for Total Hemoglobin Measurement (Frozen Liquid)
JCCRM 912 is higher-order reference material for total hemoglobin, intended to use for the calibration of cyan methemoglobin methods and spectrophotometric methods. -
CRP (C-reactive protein)
CRP, (C-reactive protein)
JC-reactive protein is a protein that increases in the blood when acute inflammation occurs in the body. This is increased by the damage to tissues resulting from trauma or illness. CRP is measured to diagnose inflammation early, and also to check the degree or course of the inflammation. -
Glycated Albumin
JCCRM 611, Certified Reference Material for Measurement of Glycated Albumin in Human Serum
JCCRM 611 is intended to use for evaluating the accuracy of Glycated Albumin assays and calibrating working reference materials, the glycated albumin concentration was determined by the JSCC reference method for GA on the basis of isotope dilution-mass spectrometry. -
Albumin
JCCRM 613, Certified Reference Material for Measurement of Albumin in Human Serum
JCCRM 613, Certified Reference Standard Material for Albumin which was prepared human serum as a raw material, assayed by HPLC-BCG method, is intended primarily for use in the calibrating and evaluating the accuracy of routine methods and validating working reference materials. This shows consistent with specimens and is traceable to ERM DA470 IFCC(albumin). -
Blood Gas
JCCRM 621, Certified Reference Material for Blood Gases (Frozen Liquid)
JCCRM 621 is intended to use for verifying the accuracy of blood gas(pH, pCO2, pO2) analyzers in clinical testing, prepared from bovine hemoglobin. The differences in the oxygen buffering capacities between human whole blood and bovine hemoglobin have been corrected by the mean differences between these two detected by almost all pO2 instruments. Therefore using the certified values, you can obtain virtually the same values as you would with human whole blood. -
JSCC Enzymes (Multi-Enzymes, Cholinesterase)
JCCLS CRM-001, Reference Material for Human Multi-Enzymes
JCCLS CRM-001 is equivalent for the secondary calibration material in metrological traceability defined in ISO 18153, intended to use for the evaluation of routine methods for AST, ALT, CK, LDH, and γ-GT in accordance with the JSCC reference methods.JCCLS CRM-002, Reference Material for Reference Standard-ChE
JCCLS CRM-002 is equivalent for the secondary calibration material in metrological traceability defined in ISO 18153, intended to provide the concentration of Cholinesterase assayed by the JSCC reference method, also to be used for evaluation of routine methods in accordance with the JSCC reference methods. -
IFCC Standards
DA 470k, ERM®-DA470k/IFCC
DA 470k is primarily intended to be used for the calibration of immunoassay-based in-vitro diagnostic devices or control products for the proteins certified by IRMM according to the principles laid down in the technical guidelines of the European Reference Materials®. (non-medical deleterious substances) 1 level contains 1.0mL, lyophilized. (23,800 JPY)DA 471, ERM®-DA471/IFCC
DA 471 is primarily intended to be used to calibrate serum-based protein standards and control materials used for the quantification of cystatin C by immunoassay by IRMM according to the principles laid down in the technical guidelines of the European Reference Materials®. (non-medical deleterious substances) 1 level contains 1.0 mL with glass vial, lyophilized.(26,800 JPY)DA 474, ERM®-DA474/IFCC
DA 474 is primarily intended to be used to calibrate serum-based protein standards and control materials of organizations which offer such preparations for the quantification of CRP by immunoassay by IRMM according to the principles laid down in the technical guidelines of the European Reference Materials®. (non-medical deleterious substances) 1 level contains 1.0 mL with glass ampoule, frozen liquid. (15,800 JPY) -
Dialysis Solutions
JCCRM 300, Certified Reference Material for Dialysate Measurement
JCCRM 300 is for dialysate measurement (pH, pCO2, HCO3-, Na, K and Cl), JCCRM 300A which is an acetic acid component and JCCRM 300C which is a citric acid component, intended for IN-VITRO diagnostic use only. -
Others
Glucose Solutions,
Glucose Standard Solution, available 10, 50, 100, 200, 300, 400, 500, 600, 1000 mg/dl and 0.9% NaCl, used NIST SRM 917c(D-Glucose: 99.7±0.3%) including 0.1% sodium benzoate.Osmol Solutions,
NaCl Standard Solution for Osmol Calibration, available 100, 200, 300, 400, 500, 700, 1000 mOsm, sodium chloride was used a standard solution for volumetric analysis by Wako Pure Chemical.NIST/NIBSC/IRMM
Reference materials are available to import. Please click "Contact Us".JCCRM 811, Certified Reference Material for Measurement of Uric Acid in Human Serum
JCCRM 811 intended to use for evaluating reference methods for determining uric acid in human serum and in validating secondary reference materials (only for oversea's customers, not available in Japan).