Test Characteristics of HbA1c net FS
DiaSys HbA1c net FS shows excellent correlation to HPLC
Minimized interferences by hemoglobin variants with HbA1c net FS
| Hb variant (≤) | HbA1c range [% DCCT/NGSP] | Recovery HbA1c [%] | |
|---|---|---|---|
| HbAS | 40% S | 5.2 - 8.8% | 94.7 |
| HbAC | 36% C | 5.0 - 7.4% | 97.1 |
| HbAD | 41% D | 5.6 - 7.0% | 93.9 |
| HbAE | 26% E | 5.9 - 7.6% | 99.1 |
| HbAJ | 50% J | 5.2 - 8.4% | 100 |
| HbAG | 20% G | 6.1 - 6.6% | 97.4 |
| HbSC | 52% S, 44% C | 4.5 - 7.0% | 91.6 |
| HbSE | 65% S, 27% E | 7.4% | 95.4 |
| HbEE | 94% E | 5.1 - 8.9% | 98.0 |
| Elevated F | 4.6% F | 6.5 - 8.1% | 93.6 |
HbA1c net FS shows excellent precision over the entire measuring range
| Intra-assay n = 20 | Mean [mmol/mol] | SD [mmol/mol] | CV [%] |
|---|---|---|---|
| Sample 1 | 32.7 | 0.31 | 0.95 |
| Sample 2 | 33.2 | 0.21 | 0.62 |
| Sample 3 | 63.7 | 0.31 | 0.48 |
| Total n = 20 | Mean [mmol/mol] | SD [mmol/mol] | CV [%] |
|---|---|---|---|
| Sample 1 | 32.1 | 0.52 | 1.63 |
| Sample 2 | 33.6 | 0.43 | 1.29 |
| Sample 3 | 67.6 | 0.82 | 1.22 |
Test Characteristics
- Liquid-stable, ready-to-use 2-component reagent
- 1-level calibrator (auto-dilution) and 2-level control
- High onboard and calibration stability
Wide measuring range from 20 to 150 mmol/mol IFCC (4 – 16 % DCCT/NGSP)
within a hemoglobin concentration range from 6 to 30 g/dL- Excellent precision
- No contamination of cuvettes by latex
- Standardized against IFCC [1] reference method and traceable to DCCT/NGSP [2]
[1] International Federation of Clinical Chemistry
[2] Diabetes Control and Complications Trial/National Glycohemoglobin Standardization Program