Description
*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

- *Aslan Secondary Reference Laboratory
IFCC Method (Hitachi 917)
Hitachi 7170

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

Hitachi 7180
(with HbA1c measurement function option)
- Calibrated on day 0 only
- 2-point calibration (3-point calibration for select devices)