the 53 rd annual meeting of the japan diabetes society nationwide surveillance study on hemoglobin...
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The 53 rd Annual Meeting of the Japan Diabetes Society
Nationwide Surveillance Study on Hemoglobin A1C by JDS in 2009
Katsuhiko Kuwa1, Masao Umemoto2, Izumi Takei3, Atsunori Kashiwagi4
National Metrology Institute of Japan1, Reference Material Institute for Clinical Chemistry Standards2, Tokyo Dental College Ichikawa General Hospital3,
Shiga University of Medical Science4
S1-4
2
JDS(%) NGSP(%)NGSP(%)
IFCC(mmol/mol ) NGSP(%)
Mono-S(%)
NGSP(%)
Global Harmonization in HbA1c Measurement
Routine measurement procedure
End-user
Manufacturer
Material Calibration Procedure Implementation
Value assignment
Routine samples
Result *
JSCC/JDS designated comparison method
(KO500)
Manufacturer’s standing measurement procedure
Working standard IFCC(mmol/mol)HbA1c(%), JDS(%)
Manufacturer’s product calibrator *
IFCC-Network※
SI
JSCC-Network※
Primary calibrator
IFCC(mmol/mol)IFCC reference method
Reference standard (JDS Lot4)
IFCC(mmol/mol)IFCC derived-JDS(%)
※ Maintenance of ME
* HbA1c ・ JDS ・ IFCC values
JSCC RMLs
Reference System for HbA1c in Japan
Participating Laboratory and Method in 2009 JDS Proficiency Testing
RegisteredClinical
Laboratories114
Manufacturers16
ReferenceLaboratories
4
RoutineClinical
Laboratories754
Immunoassay27 %
EnzymaticAssay
9 %
HPLC64 %
Total Participating Laboratories: 888 Routine Laboratories : 864
ProceduresCycle 1
Sample Delivery
→ Measurement
→ Reporting
Cycle 2
Sample Delivery
→ Measurement
→ Reporting
Cycle 3
Sample Delivery
→ Measurement
→ Reporting
Cycle 4
Sample Delivery
→ Measurement
→ Reporting
Cycle 5
Sample Delivery
→ Measurement
→ Reporting
293 Routine Laboratories
4 Samples
S1-1 ~ S1-4
289 Routine Laboratories4 Samples
S3-1 ~ S3-4
282 Routine Laboratories
4 Samples
S2-1 ~ S2-4
16 Manufacturers
10 Samples
S1-1 ~ S1-3, S2-1 ~ S2-3, S3-1 ~ S3-3,
S4-4
4 Reference Laboratories13 Samples
S1-1 ~ S1-4, S2-1 ~ S2-4, S3-1 ~ S3-4,
S4-4
Analysis of Reporting Data
Value Assingnment
4
5
6
7
8
9
10
11
12
4 5 6 7 8 9 10 11 1224
34
45
55
66
76
86
97
107
J DS(%)IFCC
(mmol/mol)
S2-2S3-2S1-2
S4-4S2-1S3-1S1-1
Target value(J DS%)
S1-3S2-3S2-3
Target Values of PT Samples in RLs
Histograms of Measured Values ( 1 )
Cycle 1 : S1-1 ~ S1-4サ イ クル 1 試料1-1(削除なし)
0
20
40
60
80
100
120
4.6 4.7 4.8 4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9J DS値(%)
(施設数)
N 293 Mean 5.24 SD 0.16 CV(%) 3.0
Lab. No. Cycle 1 S1- 1:
J DS Value(%)
サ イ クル 1 試料1-2(削除なし)
0
20
40
60
80
100
120
6.4 6.5 6.6 6.7 6.8 6.9 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7J DS値(%)
(施設数)
N 293 Mean 7.05 SD 0.18 CV(%) 2..5
Lab. No. Cycle 1 S1-2:
J DS Value(%)
サ イ クル 3 試料3-1(削除なし)
0
20
40
60
80
100
120
J DS値(%)
(施設数)
N 293 Mean 10.74 SD 0.27 CV(%) 2.6
Lab. No. Cycle 1 S1- 3:
J DS Value(%)
T.V. 5.17 (%)
T.V. 6.88 (%)
T.V. 10.59 (%)
サ イ クル 1 試料4-1(削除あり)
0
20
40
60
80
100
120
4.8 4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3 6.4
J DS値(%)
(施設数)
N 287 Mean 5.46 SD 0.17 CV(%) 3.1
Lab. No. Cycle 1 S1-4:
J DS Value(%)
T.V. 5.34 (%)
Histograms of Measured Values ( 2 )
Cycle 2 : S2-1 ~ S2-4
サ イ クル 2 試料2-2(削除あり)
0
20
40
60
80
100
120
6.7
6.8
6.9
7.0
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
8.0
8.1
8.2
8.3
8.4
J DS値(%)
(施設数)
N 281 Mean 7.56 SD 0.20 CV(%) 2.7
Lab. No. Cycle 2 : S2-2
J DS Value(%)
サ イ クル 2 試料2-3(削除あり)
0
20
40
60
80
100
120
9.0
9.1
9.29.3
9.4
9.5
9.69.7
9.8
9.910.010.110.210.310.410.510.610.710.810.9
J DS値(%)
(施設数)
N 280 Mean 9.93 SD 0.25 CV(%) 2.5
Lab. No. Cycle 2 S2- 3:
J DS Value(%)
サ イ クル 2 試料4-2(削除あり)
0
20
40
60
80
100
120
4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3 6.4 6.5
J DS値(%)
(施設数)
N 278 Mean 5.51 SD 0.18 CV(%) 3.3
Lab. No. Cycle 2 S2- 4:
J DS Value(%)
T.V. 7.40 (%)
T.V. 9.79 (%)
T.V. 5.45 (%)
サ イ クル 2 試料2-1(削除あり)
0
20
40
60
80
100
120
5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9
J DS値(%)
(施設数)
N 280 Mean 5.98 SD 0.18 CV(%) 2.9
Lab. No. Cycle 2 S2- 1:
J DS Value(%)
T.V. 5.84 (%)
Histograms of Measured Values ( 3 )
Cycle 3 : S3-1 ~ S3-4サ イ クル 3 試料3-1 (削除なし)
0
20
40
60
80
100
120
5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3 6.4
J DS値(%)
(施設数)
N 289 Mean 5.57 SD 0.16 CV(%) 2.9
Lab. No. Cycle 3 S3- 1:
J DS Value(%)
サ イ クル 3 試料3-2(削除なし)
0
20
40
60
80
100
120
6.0
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
7.0
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
J DS値(%)
(施設数)
N 289 Mean 6.83 SD 0.18 CV(%) 2.6
Lab. No. Cycle 3 S3-2:
J DS Value(%)
サ イ クル 3 試料4-3(削除なし)
0
20
40
60
80
100
120
5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3J DS値(%)
(施設数)
N 287 Mean 5.53 SD 0.16 CV(%) 2.8
Lab. No. Cycle 3 S3- 4:
J DS Value(%)
T.V. 5.47 (%)
T.V. 6.69 (%) T.V. 5.47 (%)
サ イ クル 3 試料3-3(削除あり)
0
20
40
60
80
100
120
9.59.69.79.89.910.010.110.210.310.410.510.610.710.810.911.011.111.211.311.411.5
J DS値(%)
(施設数)
N 288 Mean 10.36 SD 0.28 CV(%) 2.7
Lab. No. Cycle 3 S3- 3:
J DS Value(%)
T.V. 10.18 (%)
S1 S1S2 S2S3 S3S4
S1S2 S3
S4
S4MeanMean Mean
0.0
1.0
2.0
3.0
4.0
5.0
6.0
Cycle1 Cycle2 Cycle3
CV(%
)Comparison of CVs in Each Procedure Cycle
Procedure Cycle in Routine Laboratory
The mean CV(%) was obtained less than 3.0 % in all Samples.
Method Comparison Study ( 1 )
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
24
34
45
55
66
76
86
97
107
J DS(%)IFCC
(mmol/mol)
S1 S2 S3 S4
Cycle 1
◆ Mean
- SD
+ SD
T.V.
Method
Method Comparison Study ( 2 )
4.05.06.07.08.09.0
10.011.012.0
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
2434455566768697107
J DS(%)IFCC
(mmol/mol)
Cycle 2
Method
S1 S2 S3 S4
◆ Mean
- SD
+ SD
T.V.
Method Comparison Study ( 3 )
4.05.06.07.08.09.0
10.011.012.0
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
HPLC
Immuno assay
Enzymatic assay
2434455566768697107
J DS(%)IFCC
(mmol/mol)
Cycle 3
Method
S1 S2 S3 S4
◆ Mean
- SD
+ SD
T.V.
Accuracy Grading Based on Target Values Set by the DCM(KO500)
Within±5 %
91.6 %
7.4 %
Relative Bias(%)
The 92 % of participating laboratories were satisfied within ±5 % of relative bias against the target values.
Within±7 %0
20406080
100
±3.0%
±3.1%
~±5.0%
±5.1%
~±7.0%
±7.1%
~±10.0%
±10.1%
以上
S1(%)
S2(%)
S3(%)
S4(%)
Mean(%)
Fulfillment Rate ( % )
97.1 %
91.6 %
Within±5 % Within±7 %
Relative Bias(%)
The 92 % of participating laboratories were allowed within ±5 % of relative bias against the target values.
Conclusions1. JDS performed the proficiency testing of HbA1c
measurement for confirming the commutability in Japan.
2. Total 888 laboratories participated in this proficiency testing.
3. The mean CV was confirmed less than 3.0 % against JDS number from 5.2 % to 10.8 %.
4. The 92 % and 97 % of participating laboratories were allowed within ±5 % and ±7 % of relative bias against the accuracy grading based on target values set by designated comparison method(KO500 HPLC), respectively.
5. The commutability of inter-methods for measurement were maintained at the same degree against the former proficiency testing in 2003.
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