5 Use of reference materials

Index:
Use of reference materials・・・・・・・・・・・・・・・・・
page 5
How to select reference materials・・・・・・・・・・・・・・・ page 6
Reference materials for overseas・・・・・・・・・・・・・・・ page 9
Policy regarding stability during storage and shelf life・・・・・・ page 14
Hemoglobin A1C ・・・・・・・・・・・・・・・・・・・・
page 16
Cholesterol and TG・・・・・・・・・・・・・・・・・・・
page 18
Lipids・・・・・・・・・・・・・・・・・・・・・・・・・ page 19
Electrolytes, Na, K, Cl, Ca, Mg, Fe, IP ・・・・・・・・・・・・ page 21
Nitrogen containing compounds, Glucose, Serum iron and IP・・・ page 23
Inorganic phosphorus・・・・・・・・・・・・・・・・・・・ page 24
Standard solutions・・・・・・・・・・・・・・・・・・・・ page 25
Total hemoglobin/Blood gases・・・・・・・・・・・・・・・・page 26
Multi-type・・・・・・・・・・・・・・・・・・・・・・・・page 27
Certifications・・・・・・・・・・・・・・・・・・・・・・・page 29
Inquiry・・・・・・・・・・・・・・・・・・・・・・・・・ page 30
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Use of reference materials
ReCCS higher order reference materials
AS-NITE International Reference Materials
Reference materials to which MRA (Mutual Recognition Arrangement) through APLC
can be applied, meeting requirements of ISO Guide 34, ISO/IEC 17025 and ISO 15195.
•Hemoglobin Primary reference material for HbA1c measurements
—JCCRM 411(IFCC values, NGSP values, and JDS values)
•Serum Primary reference material for lipids measurements
— JCCRM 224 (TC, HDL-C, LDL-C and Triglycerides)
JCTLM-listed higher order reference materials (JCTLM List I)
• HbA1c
—JDS Lot 2 (assigned IFCC and NGSP values)
• Ion-Selective Electrodes
—JCCRM 111 (Na, K)
• Triglycerides (JSCC reference method, JCTLM reference method)
—JCCRM 223
5
20
20
TC
10
Bias (mg/dL)
Bias (mg/dL)
TC
0
-10
10
0
-10
-20
-20
120
160
200
120
240
160
10
10
HDL-C
5
Bias (mg/dL)
Bias (mg/dL)
HDL-C
0
-5
-10
5
0
-5
-10
30
40
50
60
70
30
40
Conc. (mg/dL)
50
60
70
Conc. (mg/dL)
20
20
LDL-C
LDL-C
10
Bias (mg/dL)
Bias (mg/dL)
240
Conc. (mg/dL)
Conc. (mg/dL)
0
-10
10
0
-10
-20
-20
60
80
100 120
60
140 160
80
100 120
140
160
Conc. (mg/dL)
Conc. (mg/dL)
20
20
Total glycerides
Total glycerides
10
Bias (mg/dL)
Bias (mg/dL)
200
0
-10
10
0
-10
-20
-20
60
80
100 120
Conc. (mg/dL)
140 160
60
80
100 120
140
160
Conc. (mg/dL)
11
20
20
20
0
-10
10
Bias (mg/dL)
Bias (mg/dL)
Bias (mg/dL)
10
0
-10
120
160
200
120
240
160
10
120
240
0
-5
60
0
-5
40
Conc. (mg/dL)
50
60
30
-10
140
0
-10
80
100
120
140
-10
60
160
-10
0
-10
200
140 160
10
0
-10
-20
-20
-20
120
Triglycerides
10
Bias (mg/dL)
Bias (mg/dL)
0
100
20
Triglycerides
10
80
Conc. (mg/dL)
20
Triglycerides
Conc. (mg/dL)
0
Conc. (mg/dL)
Conc. (mg/dL)
150
10
-20
60
20
70
LDL-C
10
160
60
20
-20
-20
50
Conc. (mg/dL)
Bias (mg/dL)
Bias (mg/dL)
0
100
40
LDL-C
10
50
-5
70
20
100 120
0
Conc. (mg/dL)
LDL-C
80
5
-10
30
20
240
HDL-C
5
70
200
10
-10
60
160
Conc. (mg/dL)
Bias (mg/dL)
Bias (mg/dL)
Bias (mg/dL)
5
50
-10
HDL-C
-10
Bias (mg/dL)
200
10
HDL-C
40
0
Conc. (mg/dL)
Conc. (mg/dL)
30
10
-20
-20
-20
Bias (mg/dL)
TC
TC
TC
50
100
150
Conc. (mg/dL)
200
50
100
150
200
Conc. (mg/dL)
12
Nitrogen containing compounds and Glucose
◊ JCCRM 521
Japanese higher order reference material (not listed in JCTLM) for urea, uric acid, creatinine
and glucose, wherein creatinine is assayed by ID/MS.
Human serum, shipped on dry ice. Store in a deep freezer for 6 months shelf life.
Routine methods for creatinine to calculate eGFR should be calibrated by a reference
material of which values are determined by ID/MS as JCCRM 521.
<<Comments>>
• 3 levels x 2 vials each x 1 ml each
Creatinine value of JCCRM 521 is assayed by state-of-the art ID/MS.
Concentrations of 4 items, uric acid, creatinine, urea and glucose, are certified.
• Glucose is measured by JSCC reference method (Deprotenization followed
by Hexokinase / G-6PDH).
• Uric acid is assayed by JSCC reference method calibrated (HPLC) with serum
primary reference material, JCCRM 811, of which concentration is assayed by
ID/MS.
• Urea is measured by a method standardized by the American Association for
Clinical Chemistry (AACC).
Serum Iron
◊ JCCRM 322
Japanese higher order reference material for serum iron measurements.
Human serum , stored in a deep freezer for 6 months shelf life.
<<Features>>
• 2 levels x 2 vials each x 1ml each
• Highly reliable assigned values measured by ICSH international standard method
combined with the standard addition method.
(Interference by copper was corrected).
23
Inorganic phosphorus
◊ JCCRM 324
Reference material for inorganic phosphorus
Human serum, store in a deep freezer for 6 months shelf life
<<Feature>>
• 3 levels x 2 vials each x 1 ml each
• Certified values are assayed by ion chromatography of which procedure is
defined by the JSCC committee for blood gases and electrolytes.
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Standard solutions
◊ Glucose standard solution (for calibration of glucose concentration)
Prepared using primary reference material, NIST SRM 917c.
Concentration range: 10 ~ 1000 mg/dL.
Benzoic acid: 1 year shelf life from the production date .
◊ Osmolality standard solution (for calibration of osmometer)
Concentration range: 100 ~ 1000 mOsm. γ-ray sterilization: 1 year shelf life from the
production date.
◊ Glucose standard solutions (various solutions ranging 10 to 1000 mg/dL)
• 100ml x 2 bottles, 50ml x 4 bottles (depending on concentration)
• No preservatives preparation is also available.
◊ Osmolality standard solutions for calibration of instruments (various solutions
ranging 100 to 1000 mOsm )
•100ml x 2 bottles, prepared according to the Japanese Pharmacopoeia for Osmotic
Pressure Standards
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Total hemoglobin/Blood gases
4.6 Total hemoglobin and blood gases
◊ JCCRM 912
Hemoglobin primary reference material for total hemoglobin measurements
Human hemoglobin, shipped on dry ice. Store in a deep freezer for 6 months shelf life
<<Intended use in routine tests >>
3 levels x 1 vial each x 0.5 ml each
• This material is to be used for calibration of total hemoglobin measurement
requiring hemolytic treatment, cyanmethemoglobin method in blood cell countors,
surfactant method in blood cell countors, ultrasonic hemolytic absorption
spectrophotometry in blood gas analysers: Provided that these methods enable red
cells to be hemolysed completely, measured values should agree with certified values
of JCCRM 912.
<<Comments>>
• This material is a hemoglobin solution.
• Used for accuracy check of routine cyanomethemoglobin method.
<<Features>>
• It is assayed rigidly by the ICSH reference method of which values are
compatible with the hemoglobin molar absorption coefficient (universal value).
◊ JCCRM 621
Working reference material for blood gas measurements
Bovine hemoglobin , shipped on dry ice. Store in a deep freezer for 6 months shelf life.
<<Intended use>>
3 levels x 2 ampoules each x 1.5ml each
• Calibration of blood gases analyzers for pH, pCO2, pO2
<<Features>>
• Prepared using bovine hemoglobin which showed close nature with human blood.
• Values measured by leading blood gas instruments are the same as the certified
values of this reference material.
26
• Ionic strength, bicarbonate concentration, BE and total hemoglobin concentration
in this hemoglobin solution meet the specifications defined by the JSCC committee
for blood gases and electrolytes
27
■ Certifications
• ISO 15195
Requirement for reference measurement laboratories in laboratory medicine
• ISO/IEC 17025
General requirements for the competence of testing and calibration laboratories
• ISO Guide 34
General requirements for the competence of reference material producers
Necessary requirements satisfied by institutes where manufacture and provide
reference materials.
• ASNITE certified calibration institute, and reference material producers
certification.
• Issuing JCTLM (Joint Committee on Traceability in Laboratory Medicine) listed
higher order reference materials.
• JCTLM reference laboratory
ISO 15195 and ISO/IEC 17025 certifications are prerequisite.
• Issuing reference materials to be used for recognition of in vitro diagnostic
reagents by the Ministry of Health, Labour and Welfare.
• Issuing reference materials for calibration of in vitro diagnostic reagents,
designated by the Ministry of Health, Labour and Welfare
29
■ Inquiry
• Home page
(search “ reccs ” )
http://www.reccs.or.jp
******************************************
• Phone to ReCCS
<<Regarding reference materials>> TEL: +81-44-813-0055
<<Regarding orders>>
TEL: +81-45-530-9107/9109
<<Institute for certifying and issuing reference materials>>
Reference Material Institute for Clinical Chemistry Standards:
Medical Association
KSP R&D A205, 3-2-1 Sakado Takatsu-ku, Kawasaki,
Kanagawa, Japan 213-0012
Tel: +81-44-850-3140 Fax: +81-44-850-3141 (Head Office)
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