NAGASE is supplying bulk reagents to detect haemoglobin A1c (HbA1c) based on latex turbidimetry.
Our cooperation partner is a Japanese pioneer in HbA1c reagents and is producing HbA1c tests completely by themselves.
Diabetes is a known chronic disease with hyperglycemia by insulin insuffficiency. It causes complications such as retinopathy, neurophathy, nephrophathy, if the disease is not controlled. There are no subjective symptoms and therefore the discovery is often delayed in mild cases.
It is estimated that the global number of diabetic patients will increase by 50 % by the year 2045.
HbA1c is a sugar bound haemoglobin protein in the red blood cells. If the blood sugar level continues to be high, the concentration of HbA1c in the blood rises.
HbA1c represents blood glucose status over the past 12 months. As diabetes is also known as a lifestyle disease the value of HbA1c is highly important as it is not dependent on diet and exercise on the day of blood collection.
Whole Blood Samples can be processed without centrifugation.
Even higher HbA1c levels are detectable (3.3 – 14,5 % (NGSP*))
We can improve latex reagents according to your needs
*National Glycohemoglobin Standardization Program
Assay: Latex Agglutination Assay
Normal Value: 4,6 – 6,2 % (NGSP*)
Measuring Range: 3,3 – 14,5 % (NGSP*)
Correlation Coefficient of 0,99 was obtained using another commercially available HPLC method.
*National Glycohaemoglobin Standardization Program
Latex Immunoagglutination Assay
This test provides a convenient, quantitative assay for measuring concentrations of haemoglobin A1c (HbA1c) in blood. The level of HbA1c is a useful index in controlling blood glucose levels in patients with diabetes. This test is based on latex immunoagglutination where HbA1c in the test sample is absorbed onto latex particles, then cross-linked anti-HbA1c is added to form an antigen-antibody reaction. Finally the percentage of HbA1c is obtained from the dose response curve.
- Since concentrations (%) of haemoglobin A1c (HbA1c) can be determined directly from the dose response curve, it is not necessary to measure haemoglobin concentrations of a test sample
- Latex agglutination assay makes it suitable for automation (open and closed systems)
- A good correlation with HPLC
- Not affected by labile haemoglobin A1c, carbamylated haemoglobin or acetylated haemoglobin
HbA1c Reagent R1
– Latex Reagent
HbA1c Reagent R2
HbA1c Calibrator Set
– For Calibration (5 Concentrations)
HbA1c Control Set
– For QC (2 Concentrations)
Our Japanese cooperation partner is the global leader in latex based HbA1c assays.
You are looking for a tailor-made solution for your needs?
We can develop and/or optimize our solution to suit your needs, whether you have a closed or open system.
Please get in touch with our IVD Unit to schedule a meeting.