- HOME
- OEM Liquid Reagent for Clinical Chemistry (Enzymatic)
- TOYOBO HbA1c Direct
-
Bulk reagent for direct enzymatic HbA1c assay
TOYOBO HbA1c Direct
NGSP-certified method
Direct enzymatic assay, no latex particles
Uses a single channel on the analyzer
Good in-use stability, stable for 4 weeks on board
Ready-to-use liquid reagent
Principle
Hemoglobin A1c (HbA1c) produces glycosylated dipeptide and H2O2 when exposed to protease.
Hemoglobin (Hb) is simultaneously denatured and autoxidized by an oxidant.
Hb is ultimately converted to methemoglobin.
H2O2 except the amount which is essential to color for assaying HbA1c percentage, is used in the methemoglobinization reaction.
Thus, regardless of the difference in the amount of hemoglobin between specimens, the HbA1c percentage can be assayed directly within the measurement range.
Single step: Direct measurement of HbA1c percentage
Assay specifications
| Method | Enzymatic assay |
|---|---|
| Specimen sample | EDTA or NaF whole blood |
| Number of channels | 1 |
| Calibration | 2-point calibration |
| Measurement range | 4%–16% (as NGSP value) |
| Correlation | HPLC method: r = 0.9832 |
| Reproducibility | Within-run: CV <5% |
| In-use stability | 4 weeks at 2°C–8°C |
Correlation with HPLC method using clinical specimens (n = 50)
No interference from the following.
Ascorbic acid: <20 mg/dL, bilirubin (free or conjugated, <12 mg/dL)
Chyle: <3,000 formazin turbidity units
Glucose: <1,000 mg/dL
Hemoglobin variant (HbF): <9.5%
Hemoglobin variant (HbS): <27.6%
Modified Hb (acetyl Hb, carbamoyl Hb, and acetaldehyde Hb): <50 mg/dL each
Assay procedure (e.g., Hitachi 917 analyzer)
A1 is the difference in absorbance between 800 and 660 nm after 5 min.
A2 is the difference in absorbance between 800 and 660 nm after 10 min.
HbA1c percentage is calculated as the difference between A1 and A2
Reagent composition
Lysis buffer
Reagent 1 solution (R1)* Each reagent is stable for 12
Reagent 2 solution (R2)months when stored at 2°C–8°C
-
CONTACT
-
For inquiries and consultations regarding our products, please contact us from inquiry form.
This page is not intended to provide information for Japan.