Glycohemoglobin A1c Kit

NORUDIA N HbA1c

We created this page for medical staff.

*Read carefully the package insert before use.

Reference Data

Within-run Reproducibility

BM 9130

  NORUDIA N HbA1c
(NGSP%)
Sample 1 Sample 2 Sample 3
1 4.7 6.3 8.8
2 4.7 6.4 8.9
3 4.8 6.4 8.9
4 4.7 6.4 8.8
5 4.8 6.4 8.9
6 4.7 6.4 8.9
7 4.7 6.4 8.9
8 4.8 6.4 8.9
9 4.7 6.4 8.8
10 4.8 6.4 8.9
Mean 4.74 6.39 8.87
S.D. 0.05 0.03 0.05
C.V.(%) 1.09 0.49 0.54
Max. 4.8 6.4 8.9
Min. 4.7 6.3 8.8
Range 0.1 0.1 0.1

Between-run Reproducibility

Hitachi 7170

  NORUDIA N HbA1c
(NGSP%)
Sample 1 Sample 2 Sample 3
1 5.0 7.0 10.3
2 4.9 7.0 10.3
3 4.9 6.9 10.2
4 5.0 7.1 10.4
5 4.9 7.0 10.3
6 5.0 6.9 10.3
7 4.9 7.0 10.2
8 4.9 7.0 10.2
9 4.9 7.0 10.3
10 5.0 7.0 10.4
Mean 4.94 6.99 10.29
S.D. 0.05 0.06 0.07
C.V.(%) 1.0 0.8 0.7
Max. 5.0 7.1 10.4
Min. 4.9 6.9 10.2
Range 0.1 0.2 0.2

Erythrocytes that had been aliquoted and frozen(-80℃), were pretreated when measurement, and were measured continuously for 10 days. (Calibration only for the first time)

Measurement of Standard Material*

  • *JCCRM 411-3 (JSD Lot5)

BM9130

  Certified Value and Uncertainty
(NGSP%)
NORUDIA N HbA1c Value
(NGSP%)
Level 1 5.10±0.13 5.08
Level 2 5.77±0.14 5.74
Level 3 7.39±0.19 7.38
Level 4 9.60±0.23 9.62
Level 5 11.98±0.28 12.12

Measurement Range

Hitachi 7170 S

HbA1c(NGSP%) :
3.3-16.6%
Hemoglobin concentration :
90-310µmol/L

Interference

Hitachi 7170

Interfering substances Concentration HbA1c Value (NGSP%)
Base Sample Including Interfering Substance
Unconjugated Bilirubin 50mg/dL 6.6 6.5
Conjugated Bilirubin 50mg/dL 6.6 6.6
Absorbic Acid 50mg/dL 6.6 6.6
Chyle 3000 FTU 6.6 6.5

Effects of modified hemoglobin and unstable hemoglobin

Hitachi 7170

Interfering substances Concentration HbA1c Value (NGSP%)
Base Sample Including Interfering Substance
Acetylated hemoglobin 50mg/dL 6.5 6.5
Carbamylated hemoglobin 50mg/dL 6.5 6.5
Acetaldehyde- hemoglobin 50mg/dL 6.5 6.5
Unstable hemoglobin 1000mg/dL 6.5 6.5

Correlation

KO500 Method (Hitachi 917)

Hitachi 7170S

KO500 Method (Hitachi 917)
  • *Aslan Secondary Reference Laboratory

IFCC Method (Hitachi 917)

Hitachi 7170

IFCC Method (Hitachi 917)

It is easy for NORUDIA N HbA1c to trasition to IFCC method value.

Change in Cell Blank Value

Change in Cell Blank Value

Hitachi 7170S

Blank values before and after 25 assays were measured and compared. Values using NORUDIA N HbA1c was nearly equivalent to that of saline at all frequencies and no latex contamination of the reaction cells were observed.

On-board Stability

On-board Stability

Hitachi 7180
(with HbA1c measurement function option)

  • Calibrated on day 0 only
  • 2-point calibration (3-point calibration for select devices)

"NORUDIA" is a trademark or registered trademark of SEKISUI MEDICAL CO., LTD. in Japan and/or other countries.

We prepared this page for medical staff (doctors, dentists, pharmacists, clinical laboratory technicians, nurses, etc.) in Japan to ensure the correct use of our products. You should be aware that the information provided is not intended for overseas medical staff and the general public.