HbA1c Latex Agglutination Reagents

Latex agglutination assay for accurate HbA1c quantification.
Supports long-term blood glucose monitoring in diabetes diagnostics with high correlation to HPLC standards.

Consistent and High-Precision Assay for Chronic Diabetes Management

Hemoglobin A1c (HbA1c) is a glycated form of hemoglobin in red blood cells and serves as a key biomarker for long-term blood glucose control. Unlike fasting glucose measurements, HbA1c reflects average blood sugar levels over the past two to three months and is unaffected by short-term dietary or activity-related fluctuations. Elevated HbA1c values are indicative of sustained hyperglycemia and are essential in diagnosing and monitoring diabetes mellitus.

Our latex agglutination assay offers accurate, NGSP-standardized quantification with excellent correlation to HPLC reference methods. It is designed for seamless integration into clinical diagnostics and OEM testing platforms.

Whole blood sample compatibility for diagnostic assays

Whole Blood Samples can be processed without centrifugation.

Wide measuring range for reliable assay performance

Even higher HbA1c levels are detectable (3.3 – 14,5 % (NGSP*))

Customization options for OEM diagnostic reagent solutions

We can improve latex reagents according to your needs
*National Glycohemoglobin Standardization Program

Our latex agglutination assay offers accurate, NGSP-standardized quantification with excellent correlation to HPLC reference methods. It is designed for seamless integration into clinical diagnostics and OEM testing platforms.

World map showing projected regional increases in diabetes prevalence by 2045. Africa leads with a 134% rise, followed by the Middle East and North Africa (+87%), South East Asia (+68%), South and Central America (+50%), Western Pacific (+27%), North America and the Caribbean (+24%), and Europe (+13%). Source: IDF Diabetes Atlas 2021.

NAGASE supplies HbA1c reagents in bulk, developed with a leading Japanese partner using in-house production for consistent quality – backed by global logistics and expert support.

Applications

HbA1c measurement is essential for long-term glucose control and diabetes diagnostics.

  • Monitoring of chronic diabetes in clinical settings
  • Diagnosis of type 1 and type 2 diabetes based on long-term glycemic control
  • Routine testing in health check-ups and preventive care
  • Evaluation of therapy effectiveness for insulin or oral hypoglycemics
  • Research studies on metabolic diseases and lifestyle disorders

Features

Our HbA1c assay uses latex turbidimetry to deliver precise, standardized results across laboratories.

  • Assay principle – Based on latex turbidimetric agglutination for high sensitivity and speed
  • Standardized range – Measuring range from 3.3% to 14.5% (NGSP)
  • High correlation – Coefficient of 0.99 compared to commercial HPLC methods
  • NGSP-aligned normal values – Reference range of 4.6% to 6.2%
  • OEM supply – Available in bulk for integration into IVD platforms

Additional Information

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.

Illustration of HbA1c detection via latex agglutination: Comparison between low and high HbA1c concentrations showing degree of agglutination and absorbance levels based on antibody binding to latex beads.

Product Specification

  • 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

Packaging Size

HbA1c Reagent R1
– Liquid
– Latex Reagent

HbA1c Reagent R2
– Liquid
– Antibodies

HbA1c Calibrator Set
– Lyophilized
– For Calibration (5 Concentrations)

HbA1c Control Set
– Lyophilized
– For QC (2 Concentrations)

Frequently Asked Questions about HbA1c Latex Agglutination Reagents

What is Hemoglobin A1c (HbA1c) and why is it important?
HbA1c is a glycated form of hemoglobin that reflects average blood glucose levels over the past 2–3 months. It is used as a reliable indicator of long-term glucose control in diabetes management.

How is HbA1c measured in this assay?
NAGASE offers a latex agglutination assay for HbA1c quantification, delivering rapid and reproducible results with strong correlation to HPLC-based reference methods.

What is the normal range for HbA1c?
According to NGSP standards, normal values lie between 4.6% and 6.2%, while diabetic patients typically show elevated levels.

What makes this assay suitable for clinical laboratories?
The assay offers a wide measuring range (3.3–14.5%), fast results, and compatibility with automated analyzers, making it ideal for high-throughput clinical use.

Can this reagent be supplied for OEM or bulk applications?
Yes, NAGASE provides the HbA1c assay in bulk quantities, ready for integration into OEM diagnostic systems worldwide.

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In Vitro Diagnostics

Aziza Aknin
Key Account Manager