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

4

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. • 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. • 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 • 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.

24

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

25

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 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. • This material is a hemoglobin solution. • Used for accuracy check of routine cyanomethemoglobin method. • 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. 3 levels x 2 ampoules each x 1.5ml each • Calibration of blood gases analyzers for pH, pCO2, pO2 • 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 TEL: +81-44-813-0055 TEL: +81-45-530-9107/9109

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)

30