Traceability of

Biochemical System Document

1 Manufacturer

DIRUI Industrial Co., Ltd.

2 DIRUI Calibrators

The calibrators of DIRUI detection system include those for such clinic detection items as routine
chemical detection items, special protein detection items and lipid detection items.

3 Composition

The main matrix component of DIRUI calibrators is serum matrix and sometimes is water matrix
standard liquid.

4 Scope of application of DIRUI calibrators

DIRUI calibrators are used for calibration in concentration determination of clinical biochemical
items of serum, plasma, or urine specimen, together with fully automatically biochemical
analyzers (such as DIRUI CS-series biochemical analyzer, Hitachi biochemical analyzer, Olympus
biochemical analyzer, Toshiba biochemical analyzer, Abbott biochemical analyzer and Beckmann
biochemical analyzer) and DIRUI reagents, to ensure the accuracy of determination results. Please
see the attachment for the information related to calibrators of test items.

5 Traceability
5.1 Traceability Document

The measurement of DIRUI calibrators should be designed and implemented in accordance with
relevant international and national standards and codes.
1) GB/T 21415-2008/ISO 17511: 2003 In Vitro Diagnostic Medical Devices—Measurement of
Quantities in Biological Samples—Metrological Traceability of Values Assigned to
Calibrators and Control Materials
2) YY/T0638-2008/ISO 18153: 2003 In Vitro Diagnostic Medical Products—Measurement of
Quantities in Biochemical Samples—Metrological Traceability of Fixed Value of Enzymatic
Concentration in Calibrators and Control Materials
3) GB/T19702-2005/ISO 15193: 2002 In Vitro Diagnostic Medical Devices—Measurement of
Quantities in Biogenic Sample—Description of Reference Measurement Procedure
4) GB/T19703-2005/ISO 15194: 2002 In Vitro Diagnostic Medical Devices—Measurement of
Quantities in Biogenic Sample—Description of Reference Materials

1
5.2 Basic Concepts

Definition of traceability: through an uninterrupted comparison chain with specified uncertainty,

the value of the measurement result or measurement standard can be compared with the specified
reference standard, which is usually a characteristic linked to a national standard or an
international standard.
Purpose of clinical testing: To report reliable results on fresh specimens of patients. In clinical
testing, it is recognized that in reference laboratories, operators with accredited qualifications use
reference methods, or use reference products as standards, and the test results of fresh specimens
are the results of reference values. However, all the reference methods in the reference laboratory
are manual methods, or the method of using a reference product to calibrate, which is very
cumbersome to achieve the transfer of reference values. In daily testing, it is impossible to use
such reference methods or reference materials to test a large number of patient specimens and
issue reports. Therefore, how to get the same measurement value as the reference series with the
conventional detection system for the detection of patient specimens under the premise of the
same measurement unit has become the key.
DIRUI strictly standardizes all components (instrument, reagent, calibrator, and operating
procedure) of the detection system involved in detection to realize measurement traceability of
calibrators and finally realize the traceability of fresh specimen results.

5.3 Measurement Traceability of Dirui Calibrators

According to the requirements of ISO 17511 and JCTLM (Joint Committee on Traceability of
Laboratory Medicine), the value of DIRUI's calibrator is traceable to the highest level of existing
calibration level, and the reference method or reference product for the traceability of the
company's product to patient specimen test results is determined. And with reference to ISO17511
and ISO18153, the measurement traceability diagram of DIRUI calibrator is formulated and
implemented. The measurement traceability diagram shows the traceability chain of test results
and the calibration level of the calibrator. The procedure of assignment and transfer of each test
item of the calibrator varies according to its highest measurement reference.
At present, some of our company's products specify the reference methods or reference products
listed in the following table for calibrator traceability. See the attachment for the traceability
information of DIRUI's calibrator and the traceability diagram of the calibrator.

Table 1 Traceability table of calibrators for the Biochemical Kit of DIRUI Detection System
No. Item Name Abbreviation Reference Method Reference Material

1 Total protein TP IFCC Recommended Method/biuret method GBW09188

2 Glucose GLU-OX Isotopic dilution mass spectrometry GBW09174a

Isotopic dilution mass spectrometry；

3 Glucose GLU-HK GBW09174a
Spectrophotometry
Isotopic dilution mass spectrometry；
4 Blood urea nitrogen UREA GBW09174a
Spectrophotometry
5 Uric acid UA Isotopic dilution mass spectrometry GBW09174a

2
6 Creatinine CRE-J Isotopic dilution mass spectrometry In-company method

7 Creatinine CRE-E Isotopic dilution mass spectrometry GBW09174a

8 Triglyceride TG Isotopic dilution mass spectrometry GBW 09146

9 Total cholesterol TC Abell-Kendall Method GBW 09146

10 Inorganic phosphorus PHOS / JCCRM 321-7M

11 Chloride ion CL Coulometric titration method GBW09152

12 Zinc Zn Flame atomic absorption spectrometry GBW09152

13 Magnesium ion Mg Atomic absorption GBW09152

Flame atomic absorption spectrometry，Ion
14 Calcium Ca-ARS GBW09152
chromatography

Flame atomic absorption spectrometry，Ion

15 Calcium Ca-CPC GBW09152
chromatography

Creatine kinase MB
16 CK-MB / In-company method
isoenzyme
17 Total bilirubin TBIL Jendrassik-Grof Method In-company method

18 Direct bilirubin DBIL / In-company method

19 Total bile acid TBA / In-company method

20 Carbon dioxide CO2 / In-company method

21 Fructosamine FMN / In-company method

22 Albumin ALB Immunoturbidimetry ERM-DA470K/IFCC

23 Prealbumin PA Immunoturbidimetry ERM-DA470K/IFCC
24 Immune globulin A IgA Immunoturbidimetry ERM-DA470K/IFCC

25 Immune globulin G IgG Immunoturbidimetry ERM-DA470K/IFCC

26 Immune globulin M IgM Immunoturbidimetry ERM-DA470K/IFCC

27 Complement C3 C3 Immunoturbidimetry ERM-DA470K/IFCC

28 Complement C4 C4 Immunoturbidimetry ERM-DA470K/IFCC

29 Rheumatoid factor RF / In-company method

30 Transferrin TRF Immunoturbidimetry ERM-DA470K/IFCC

31 C-reactive protein CRP Immunoturbidimetry In-company method
High density lipoprotein
32 HDL-C Ultracentrifugation-AK SRM1951b
cholesterol

Low density lipoprotein

33 LDL-C β-Quantitative method SRM1951b
cholesterol
34 Apolipoprotein A1 APO A1 / In-company method

35 Apolipoprotein B APO B / In-company method

36 Lipoprotein (a) Lp（a） Enzyme-linked immunosorbent assay In-company method

37 β2-microglobulin β2-MG / In-company method

38 Cystatin C CYS-C Immunoturbidimetry In-company method

39 Homocysteine HCY ID/GC/MS In-company method

Glycosylated
40 HbA1C HPLC-CE ID/LC/MS GBW09181
hemoglobin

41 5`-Nucleotidase 5`-NT / In-company method

42 Anti-Streptolysin O ASO / In-company method

3
 Microalbuminuria
43 MALB / In-company method
determination kit

44 Adenosine deaminase ADA / In-company method

45 Total protein in urine TPU / GBW09188

N-Acetyl-β
46 NAG / In-company method
-D-Glucosaminidase

47 Potassium ion K Ion chromatography ，Atomic absorption SRM956d

48 Sodium ion NA Ion chromatography ，Atomic absorption SRM956d

49 Chloride ion CL Coulometric titration method SRM956d

Table 2 DIRUI Detection System Clinical Chemistry Calibration Serum’s Traceability

No. Item Name Abbreviation Reference Method Reference Material

1 Total protein TP IFCC Recommended Method/biuret method SRM927d

2 Glucose GLU-OX Isotopic dilution mass spectrometry SRM965b
Isotopic dilution mass spectrometry；
3 Glucose GLU-HK SRM965b
Spectrophotometry

Isotopic dilution mass spectrometry；

4 Blood urea nitrogen UREA SRM909c
Spectrophotometry

5 Uric acid UA Isotopic dilution mass spectrometry SRM909c

6 Creatinine CRE-J Isotopic dilution mass spectrometry SRM914a

7 Creatinine CRE-E Isotopic dilution mass spectrometry SRM914a

8 Triglyceride TG Isotopic dilution mass spectrometry SRM909c

9 Total cholesterol TC Abell-Kendall Method SRM909c

10 Inorganic phosphorus PHOS / JCCRM 321-7M

11 Chloride ion CL Coulometric titration method SRM956d

12 Zinc Zn Flame atomic absorption spectrometry BCR639

13 Magnesium ion Mg Atomic absorption SRM956d

Flame atomic absorption spectrometry，Ion

14 Calcium Ca-ARS SRM956d
chromatography

Flame atomic absorption spectrometry，Ion

15 Calcium Ca-CPC SRM956d
chromatography
16 Total bilirubin TBIL Jendrassik-Grof Method SRM916a

17 Direct bilirubin DBIL / In-company method

18 Total bile acid TBA / In-company method

19 Carbon dioxide CO2 / In-company method

20 Albumin ALB Immunoturbidimetry ERM-DA470K/IFCC

Alanine
21 ALT IFCC Recommended Method JCCLS CRM 001C
aminotransferase
22 Aspartate transaminase AST IFCC Recommended Method ERM-AD457/IFCC

23 Alkaline phosphatase ALP IFCC Recommended Method IFCC method

24 Amylase AMY IFCC Recommended Method IRMM/IFCC-456

25 Lactate dehydrogenase LDH IFCC Recommended Method ERM-AD453/IFCC

26 γ- glutamyl transferase GGT IFCC Recommended Method ERM-AD452/IFCC

4
27 Creatine kinase CK IFCC Recommended Method JCCLS CRM 001C

28 Pancreatic amylase PAMY / IRMM/IFCC-456

29 Total bilirubin TB-V Jendrassik-Grof Method SRM916a

30 Direct bilirubin DB-V / In-company method

31 Cholinesterase CHE / In-company method

α-hydroxybutyric
32 HBDH / In-company method
dehydrogenase

Glutamate
33 GLDH / In-company method
dehydrogenase

34 Leucine aminopeptidase LAP / In-company method

Total iron-binding
35 TIBC / In-company method
capacity

36 Fe IRON / Weighing method

37 Lactic acid LAC Weighing method In-company method

Note: ERM/IRMM/BCR=Reference materials approved by Standard Bureau of European

Communities
SRM = Standard reference material of the USA.
NIBSC= National Institute for Biochemical Standards and Control

6 Quality Assurance
6.1 Reference lab of Dirui

Establish a reference laboratory to study and establish reference methods for clinical testing items
to achieve the accurate and reliable clinical test results of the Di Rui biochemical testing system,
blood cell testing system, and urine testing system. The first-level reference method of IFCC
enzymology and the reference method of small molecule analysis project have been established. In
the process of determining the value of the calibrator, the reference materials used for calibration
and verification shall be used strictly in accordance with the instructions for use of the reference
materials, and the stability of the environmental conditions shall be ensured. The main measuring
instruments are regularly checked and calibrated by the measuring institutions to ensure the
traceability of the measuring instruments. The reference laboratory was accredited by the China
National Accreditation Service for Conformity Assessment Reference Laboratory on April 22,
2019. For details, please refer to the China National Accreditation Service for Conformity
Assessment (CNAS) website www.cnas-org.cn. The certificate is as follows:

5
6.2 EQA
6.2.1 RELA

Regularly participate in the global reference laboratory reference method comparison program
(RELA) organized by the international IFCC to ensure the continuous accuracy of the reference
method run by the laboratory and ensure the accuracy and reliability of the reference method
setting. The following figure is an example of the evaluation results of participating in the 2018
RELA International Reference Laboratory Reference Method Comparison Enzymology AMY,
GGT, AST, ALT, LDH, TP, UREA and other items, the test results of each item of DIRUI are all
within the target value box, which means that the results are qualified. For details, please refer to
the website of the International Society for Clinical Chemistry (IFCC) www.dgkl-rfb.de:81

6
7
6.2.2 NCCL EQA

Dirui regularly takes part in and passed the external quality assessment for tests by conventional
methods which is organized by the National Center for Clinical Laboratories and verified the
assignment ability of its detection and calibration labs to ensure the accuracy and reliability of the
testing system.

8
EQA of the regular chemical analysis, include: K, Na, Cl, Ca, Glu, BUN, UA, CRE, TP, ALB, TC,
TG, TB, ALT, AST, ALP, AMY, CK, LDH, GGT, DB, Fe, TIBC, Zn, CHE, HBDH.

EQA of the special protein analysis, include IgA, IgG, IgM, C3, C4, CRP, RF, ASO, FER, PA.

9
 EQA of the HbA1c item.

EQA of the lipid analysis, include TC, TG, HDL-C, LDL-C, Lp(a), Apo A1, Apo B.

10
EQA of urine sample analysis, include K, Na, Cl, Ca, Glu, BUN, CRE, UA, TP, MALB.

EQA of the CYS-C.

11
 EQA of the blood RBP.

EQA of the myocardial markers analysis, include CK-MB(μg/L), MYO, cTnl (Hypersensitive).

12
 EQA of the metabolite analysis, include GLU, BUN.

EQA of the enzymology analysis, include GGT, LDH, CK, AMY, ALP, ALT.

13
 List of traceability of test items

Reference material or

Detection method for calibrator

No. Category Name Abbr. Detection Method Instrument Calibrator
Reagent measurement

traceability

Alanine IFCC Recommended JXZZ Dirui CS series Clinical chemistry calibration

1 ALT JCCLS CRM 001C
aminotransferase Method 20172400261 Auto-Chemistry serum/JXZZ 20172400210

Aspartate IFCC Recommended JXZZ Analyzer，JXZZ Clinical chemistry calibration

2 AST ERM-AD457
transaminase Method 20172400260 20172400171、 serum/JXZZ 20172400210

γ- glutamyl IFCC Recommended JXZZ JSYJX(Z)Zi Clinical chemistry calibration

3 γ-GGT ERM-AD452
transferase Method 20172400263 20132400167、 serum/JXZZ 20172400210
Biochemistry

IFCC Recommended JXZZ JSYJX(Z)Zi Clinical chemistry calibration

4 Amylase AMY IRMM/IFCC 456
Method 20172400270 20142400152、 serum/JXZZ 20172400210

IFCC Recommended JXZZ JSYJX(Z)Zi Clinical chemistry calibration

5 Creatine kinase CK JCCLS CRM 001C
Method 20172400267 20142400201、 serum/JXZZ 20172400210

Lactate JXZZ JSYJX(Z)Zi Clinical chemistry calibration

6 LDH Substrate method ERM-AD453
dehydrogenase 20172400268 20142400202、 serum/JXZZ 20172400210

Alkaline IFCC Recommended JXZZ JSYJX(Z)Zi Clinical chemistry calibration IFCC Recommended
7 ALP
phosphatase Method 20172400262 20142400203、 serum/JXZZ 20172400210 Method

14
 Blood urea JXZZ JXZZ Clinical chemistry calibration
8 UREA Enzymatic method SRM 909C
nitrogen 20172400227 20142400003、 serum/JXZZ 20172400210

Enzymatic method JXZZ JXZZ Clinical chemistry calibration

9 Creatinine CRE-ENZYME SRM914a
（540nm） 20172400229 20152400003、 serum/JXZZ 20172400210

JXZZ JXZZ Clinical chemistry calibration

10 Creatinine CRE Picric acid method SRM914a
20172400230 20162400020、 serum/JXZZ 20172400210

JXZZ JXZZ Clinical chemistry calibration

11 Total bilirubin TB Diazonium-salt method SRM 916a
20172400220 20162400183、 serum/JXZZ 20172400210

Vanadate oxidation JXZZ JXZZ Clinical chemistry calibration

12 Total bilirubin TB-V SRM 916a
method 20152400036 20162400210、 serum/JXZZ 20172400210

JXZZ JXZZ Clinical chemistry calibration

13 Uric acid UA Diazonium-salt method SRM 909C
20172400228 20172400170、 serum/JXZZ 20172400210

JXZZ Clinical chemistry calibration

14 Glucose GLU-HK Hexokinase method SRM965b
20172400225 serum/JXZZ 20172400210

JXZZ Clinical chemistry calibration

15 Glucose GLU-OX Oxidase method SRM965b
20172400226 serum/JXZZ 20172400210

JXZZ Clinical chemistry calibration

16 Total protein TP Biuret method SRM 927d
20172400223 serum/JXZZ 20172400210

JXZZ Clinical chemistry calibration

17 Total cholesterol TC Enzymatic method SRM 909C
20172400231 serum/JXZZ 20172400210

15
 JXZZ Clinical chemistry calibration
18 Triglyceride TG Oxidase method SRM 909C
20172400232 serum/JXZZ 20172400210

Magnesium blue JXZZ Clinical chemistry calibration

19 Magnesium ion Mg SRM 956d
method 20172400236 serum/JXZZ 20172400210

Mercury thiocyanate JXZZ Clinical chemistry calibration

20 Chloride ion CL SRM 956d
method 20172400235 serum/JXZZ 20172400210

Inorganic Direct ultraviolet JXZZ Clinical chemistry calibration

21 PHOS JCCRM 321-7M
phosphorus method 20172400237 serum/JXZZ 20172400210

O-Cresolphthalein JXZZ Clinical chemistry calibration

22 Calcium Ca-ARS SRM 956d
complexone method 20172400233 serum/JXZZ 20172400210

JXZZ Clinical chemistry calibration

23 Calcium Ca-CPC Arsenazo III method SRM 956d
20172400234 serum/JXZZ 20172400210

Bromocresol green JXZZ Clinical chemistry calibration

24 Albumin ALB ERM DA-470K
method 20172400224 serum/JXZZ 20172400210

Selected
JXZZ Clinical chemistry calibration
25 Direct bilirubin DB Diazonium-salt method measurement
20172400221 serum/JXZZ 20172400210
procedure

Selected
Vanadate oxidation JXZZ Clinical chemistry calibration
26 Direct bilirubin DB-V measurement
method 20152400039 serum/JXZZ 20172400210
procedure

16
 Selected
Enzymatic cycling JXZZ Clinical chemistry calibration
27 Total bile acid TBA measurement
method 20172400222 serum/JXZZ 20172400210
procedure

Selected
JXZZ Clinical chemistry calibration
28 Carbon dioxide CO2 Enzymatic method measurement
20172400239 serum/JXZZ 20172400210
procedure

Selected
JXZZ Clinical chemistry calibration
29 Cholinesterase CHE Substrate hydrolysis measurement
20172400264 serum/JXZZ 20172400210
procedure

Selected
Glutamate Modified DGKC JXZZ Clinical chemistry calibration
30 GLDH measurement
dehydrogenase method 20172400265 serum/JXZZ 20172400210
procedure

Selected
Leucine JXZZ Clinical chemistry calibration
31 LAP Substrate hydrolysis measurement
aminopeptidase 20172400266 serum/JXZZ 20172400210
procedure

Selected
α-hydroxybutyric DGKC JXZZ Clinical chemistry calibration
32 HBDH measurement
dehydrogenase recommendation 20172400269 serum/JXZZ 20172400210
procedure

JXZZ Clinical chemistry calibration Selected

33 Lactic acid LAC Enzymatic colorimetry
20162400216 serum/JXZZ 20172400210 measurement

17
 procedure

Pancreatic JXZZ Clinical chemistry calibration

34 P-AMY Oxidase method IRMM/IFCC 456
amylase 20152400037 serum/JXZZ 20172400210

Complex chromogenic JXZZ Clinical chemistry calibration

35 Zinc Zn BCR639
method 20172400238 serum/JXZZ 20172400210

Total Selected
JXZZ Clinical chemistry calibration
36 iron-binding TIBC FERENE method measurement
20152400071 serum/JXZZ 20172400210
capacity procedure

JXZZ Clinical chemistry calibration

37 Fe IRON FERENE method Weighing method
20152400072 serum/JXZZ 20172400210

List of traceability of test items

Reference material or

Detection method for calibrator

No. Category Name Abbr. Detection Method Instrument Calibrator
Reagent measurement

traceability

Dirui CS series Auxiliary

Biochemistry

JXZZ
1 Blood urea nitrogen UREA Enzymatic method Auto-Chemistr calibrators/JXZZ GBW09174a
20172400227
y Analyzer， 20172400227

18
 JXZZ Auxiliary
CRE-ENZYM Enzymatic method JXZZ
2 Creatinine 20172400171、 calibrators/JXZZ GBW09174a
E （540nm） 20172400229
JSYJX(Z)Zi 20172400229

20132400167、 Auxiliary Selected

JXZZ
3 Creatinine CRE Picric acid method JSYJX(Z)Zi calibrators/JXZZ measurement
20172400230
20142400152、 20172400230 procedure

JSYJX(Z)Zi Auxiliary Selected

JXZZ
4 Total bilirubin TB Diazonium-salt method 20142400201、 calibrators/JXZZ measurement
20172400220
JSYJX(Z)Zi 20172400220 procedure

20142400202、 Auxiliary
JXZZ
5 Uric acid UA Diazonium-salt method JSYJX(Z)Zi calibrators/JXZZ GBW09174a
20172400228
20142400203、 20172400228

JXZZ Auxiliary
JXZZ
6 Glucose GLU-HK Hexokinase method 20142400003、 calibrators/JXZZ GBW09174a
20172400225
JXZZ 20172400225

20152400003、 Auxiliary
JXZZ
7 Glucose GLU-OX Oxidase method JXZZ calibrators/JXZZ GBW09174a
20172400226
20162400020、 20172400226

JXZZ JXZZ Auxiliary

8 Total protein TP Biuret method GBW09188
20172400223 20162400183、 calibrators/JXZZ

19
 JXZZ 20172400223

20162400210、 Auxiliary
JXZZ
9 Total cholesterol TC Enzymatic method JXZZ calibrators/JXZZ GBW09146
20172400231
20172400170、 20172400231

Auxiliary
JXZZ
10 Triglyceride TG Oxidase method calibrators/JXZZ GBW09146
20172400232
20172400232

Auxiliary
Magnesium blue JXZZ
11 Magnesium ion Mg calibrators/JXZZ GBW09152
method 20172400236
20172400236

Auxiliary
Mercury thiocyanate JXZZ
12 Chloride ion CL calibrators/JXZZ GBW09152
method 20172400235
20172400235

Auxiliary
Direct ultraviolet JXZZ
13 Inorganic phosphorus PHOS calibrators/JXZZ JCCRM 321-7M
method 20172400237
20172400237

Auxiliary
O-Cresolphthalein JXZZ
14 Calcium Ca-ARS calibrators/JXZZ GBW09152
complexone method 20172400233
20172400233

15 Calcium Ca-CPC Arsenazo III method JXZZ Auxiliary GBW09152

20
 20172400234 calibrators/JXZZ

20172400234

Auxiliary
Bromocresol green JXZZ
16 Albumin ALB calibrators/JXZZ ERM-DA470K/IFCC
method 20172400224
20172400224

Auxiliary Selected
JXZZ
17 Direct bilirubin DB Diazonium-salt method calibrators/JXZZ measurement
20172400221
20172400221 procedure

Auxiliary Selected
Enzymatic cycling JXZZ
18 Total bile acid TBA calibrators/JXZZ measurement
method 20172400222
20172400222 procedure

Auxiliary Selected
JXZZ
19 Carbon dioxide CO2 Enzymatic method calibrators/JXZZ measurement
20172400239
20172400239 procedure

Auxiliary
Complex chromogenic JXZZ
20 Zinc Zn calibrators/JXZZ GBW09152
method 20172400238
20172400238

Auxiliary Selected
Creatine kinase MB JXZZ
21 CK-MB Immunosuppression calibrators/JXZZ measurement
isoenzyme 20172400251
20172400251 procedure

21
 Auxiliary Selected
Enzymatic cycling JXZZ
22 Homocysteine HCY calibrators/JXZZ measurement
method 20172400256
20172400256 procedure

Auxiliary Selected
JXZZ
23 Adenosine deaminase ADA Enzymatic method calibrators/JXZZ measurement
20172400271
20172400271 procedure

Selected
JXZZ Auxiliary
24 Fructosamine FMN NBT reduction method measurement
20192400118 calibrators/JXZZ
procedure

ISE blood
JXZZ
25 Sodium ion Na(ISE) Indirect Potentiometry calibrators/JXZZ SRM 956d
20172400204
20172400207
/
ISE blood
JXZZ
26 Potassium ion K(ISE) Indirect Potentiometry calibrators/JXZZ SRM 956d
20172400205
20172400207
/
ISE blood
JXZZ
27 Chloride ion CL(ISE) Indirect Potentiometry calibrators/JXZZ SRM 956d
20160082
20172400207

JXZZ Auxiliary Selected

28 5’-Nucleotidase 5`-NT Enzymatic method
20172400254 calibrators/JXZZ measurement

22
 20172400254 procedure

Auxiliary
Immune transmission JXZZ
29 Prealbumin PA（TTR） calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400243
20172400243

Auxiliary
Immune transmission JXZZ
30 Immune globulin A IgA calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400240
20172400240

Auxiliary
Immune transmission JXZZ
31 Immune globulin G IgG calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400241
20172400241
Immune

Auxiliary
Immune transmission JXZZ
32 Immune globulin M IgM calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400242
20172400242

Auxiliary
Immune transmission JXZZ
33 Complement C3 C3 calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400244
20172400244

Auxiliary
Immune transmission JXZZ
34 Complement C4 C4 calibrators/JXZZ ERM DA-470K/IFCC
turbidity method 20172400245
20172400245

35 Transferrin TRF Immune transmission JXZZ Auxiliary ERM DA-470K/IFCC

23
 turbidity method 20152400038 calibrators/JXZZ

20152400038

Auxiliary Selected
Latex-enhanced JXZZ
36 C-reactive protein CRP calibrators/JXZZ measurement
immunoturbidimetry 20172400258
20172400258 procedure

Auxiliary Selected
Latex-enhanced JXZZ
37 Anti-Streptolysin O ASO calibrators/JXZZ measurement
immunoturbidimetry 20172400298
20172400298 procedure

Auxiliary Selected
Latex-enhanced JXZZ
38 Rheumatoid factor RF calibrators/JXZZ measurement
immunoturbidimetry 20172400252
20172400252 procedure

Auxiliary
Latex agglutination JXZZ
39 Glycosylated hemoglobin HbA1c calibrators/JXZZ GBW09181
method 20172400255
20172400255

Auxiliary Selected
Latex agglutination JXZZ
40 Cystatin C CYS-C calibrators/JXZZ measurement
method 20172400259
20172400259 procedure

Auxiliary Selected
Latex-enhanced JXZZ
41 β2-microglobulin β2-MG calibrators/JXZZ measurement
immunoturbidimetry 20172400257
20172400257 procedure

24
 Auxiliary Selected
Latex agglutination JXZZ
42 Lipoprotein (a) Lp(a) calibrators/JXZZ measurement
method 20172400253
20172400253 procedure

Auxiliary Selected
Immune transmission JXZZ
43 Apolipoprotein A1 APO A1 calibrators/JXZZ measurement
turbidity method 20172400246
20172400246 procedure

Auxiliary Selected
Immune transmission JXZZ
44 Apolipoprotein B APO B calibrators/JXZZ measurement
turbidity method 20172400247
20172400247 procedure

Auxiliary
High density lipoprotein Direct determination JXZZ
45 HDL-C calibrators/JXZZ SRM1951b
cholesterol method 20172400249
20172400249

Auxiliary
Low density lipoprotein Direct determination JXZZ
46 LDL-C calibrators/JXZZ SRM1951b
cholesterol method 20172400250
20172400250

Auxiliary Selected
Microalbuminuria Immune transmission JXZZ
47 MALB calibrators/JXZZ measurement
determination kit turbidity method 20172400248
20172400248 procedure

JXZZ Auxiliary
48 Total protein in urine TPU Turbidity method GBW09188
20152400077 calibrators/JXZZ

25
 20152400077

Auxiliary Selected
N-Acetyl-β-D-Glucosaminidas JXZZ
49 NAG MPT substrate method calibrators/JXZZ measurement
e 20152400074
20152400074 procedure

26
Attachment: Example of Traceability Diagram

Traceability Diagram of AST

a) Traceability Description
According to ISO 17511 and JCTLM (Joint Committee for Laboratory Medicine Traceability),
aspartate aminotransferase values are strictly traceable to the international reference substance
ERM-AD457/IFCC. The detection system includes aspartic acid aminotransferase assay kit
(aspartic acid substrate method), clinical chemical calibration serum, DIRUI CS-series chemistry
analyzer.
b) Measurement Traceability Diagram
According to ISO 17511:2003 "In Vitro Diagnostic Medical Products - Measurement of Quantities
in Biological Samples - Measurement traceability of values for calibration and control substances",
aspartate aminotransferase has a reference measurement procedure and an international reference
substance that can be metrological traceable to SI.

27
 Traceability Diagram of MALB calibration

a) Traceability Description
According to ISO 17511 and JCTLM (Joint Committee on Traceability of Laboratory Medicine),
the value of urine microalbumin is strictly traced to the company's internal methods. The detection
system includes MALB reagent kit (immunoturbidimetric method), calibrator, and DIRUI
CS-series chemistry analyzers.
b) Measurement Traceability Diagram
According to ISO 17511:2003 "In Vitro Diagnostic Medical Products-Measurement of Amount in
Biological Samples-Metrological Traceability of Calibrators and Controls", there is no
internationally agreed reference measurement procedure and agreed calibrator for urine
microalbumin. It cannot be traced back to SI in measurement.

28