Description
Product Overview
The HbA1c Rapid Test Kit is a one-step colloidal gold immunoassay designed for quantitative detection of glycated hemoglobin (HbA1c) in human whole blood. HbA1c reflects the average blood glucose concentration over the previous two to three months and is widely used for monitoring glycemic control in diabetic patients.
This test is compatible with FIA8000 quantitative immunoassay analyzer and provides rapid and reliable results for clinical laboratories and point-of-care testing environments.
Clinical Significance
Hemoglobin A1c (HbA1c) is formed by the attachment of glucose to hemoglobin molecules in red blood cells. The HbA1c level reflects the average blood glucose concentration during the lifespan of red blood cells.
Measurement of HbA1c is commonly used for:
• Monitoring long-term glycemic control in diabetes
• Assessing risk of diabetes complications
• Evaluating effectiveness of diabetes treatment
• Screening individuals at risk of developing diabetes
The World Health Organization recommends HbA1c testing as an important marker for diabetes diagnosis and monitoring.
Test Principle
The test uses colloidal gold labeled anti-human Hb monoclonal antibodies and anti-human HbA1c monoclonal antibodies coated on the test strip. When a blood sample is added, HbA1c and hemoglobin bind to antibodies forming antigen-antibody complexes.
The complex migrates through the test strip and is captured by the detection line where the color intensity corresponds to the HbA1c concentration. The FIA8000 analyzer reads the signal and displays the quantitative result.
Sample Type
Whole Blood
Heparin, sodium citrate, and EDTA can be used as anticoagulants.
Sample Volume
Test Time
Approximately 3 minutes reaction time after inserting the test card into the FIA8000 analyzer.
Measuring Range
Detection limit: ≤2.0%
Technology: Colloidal Gold Immunoassay
Analyzer Compatibility: FIA8000 Quantitative Immunoassay Analyzer
Kit Contents
Each kit contains:
• HbA1c test cards
• Sample diluent
• Capillary pipette
• User manual
• Desiccant sealed pouch
Storage and Stability
• Store test cards at 4–30°C
• Validity period 24 months
• Use test card within 1 hour after opening foil pouch
Intended Use
The HbA1c Rapid Test Kit is intended for quantitative measurement of glycated hemoglobin (HbA1c) in human whole blood samples. The test is used as an aid for monitoring long-term glycemic control in patients with diabetes.
Applications
This test kit can be used in:
• Hospital laboratories
• Diagnostic centers
• Diabetes clinics
• Point-of-care testing settings
