Finecare HbA1c Rapid Quantitative Test

The Finecare™ HbA1c Rapid Quantitative Test is a fluorescence immunoassay designed for the quantitative determination of Hemoglobin A1c (HbA1c) levels in human whole blood. This test, used in conjunction with the Finecare™ FIA System, aids in monitoring long-term glycemic control in patients with diabetes mellitus. ​

Key Features:

• Sample Type: Whole blood.​
• Sample Volume: Requires 5 µL of the sample
• Reaction Time: Provides results in approximately 5 minutes.​
• Measuring Range: Capable of measuring HbA1c concentrations between 4.0% and 14.5%.​
• Certifications: CE, NGSP, and IFCC certified. ​

Storage and Stability:

• Store the test kit at temperatures between 4℃ and 30℃ up to the expiration date printed on the package.​
• If refrigerated, allow the test kit to reach room temperature (approximately 30 minutes) before testing.​
• Use the test cartridge within one hour of opening the pouch. ​

Clinical Significance:

HbA1c is formed by the attachment of glucose to hemoglobin molecules in red blood cells and reflects the average blood glucose level over the past 2-3 months. Monitoring HbA1c levels is crucial for assessing long-term glycemic control in diabetic patients. Normal HbA1c levels in individuals without diabetes range from 4% to 5.9%. Patients with diabetes typically have HbA1c levels above 7%. Reducing HbA1c levels by 1% can decrease the risk of microvascular complications by 10%. ​

Performance Evaluation:

A study evaluating the Finecare™ HbA1c Rapid Quantitative Test demonstrated that it is a reliable and rapid assay (5 minutes) suitable for long-term monitoring of HbA1c in diabetic patients, particularly in small laboratory settings.

Usage Considerations:

• Ensure that the test cartridge, buffer, and ID chip lot numbers match before use.​
• Allow the test kit to reach room temperature if previously refrigerated.​
• Use the test cartridge within one hour of opening the pouch.​
• Follow proper laboratory safety techniques when handling specimens and kit reagents. ​