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)
NORUDIA N HbA1c
