Individual Test Cartridge POCT HbA1c Analyzer For Glycosylated Hemoglobin Test

The Individual Test Cartridge POCT HbA1c Analyzer For Glycosylated Hemoglobin TestI is a automated desktop point-of-care analyzer for measuring glycated hemoglobin (HbA1c) to diabetes diagosis.

The Test Cartridge is individually packaged containing the reagents necessary for the determination of hemoglobin A1c one test.

Specification

Principle

The analyzer works based on the principle of boric acid affinity fluorescence quenching. The content of HbA1c is quantitatively detected by detecting the amount of fluorescent substance changing with the binding and quenching of HbA1c and fluorescent substance.

The Application of Boronate affinity in Individual Test Cartridge POCT HbA1c Analyzer For Glycosylated Hemoglobin Test.

After the magnetic beads are pushed into the kit, the borate in the reagent binds to the fluorophore in the magnetic beads, resulting in a large amount of excited fluorescence

After the magnetic beads are pushed into the kit, the borate binds to the fluorophore, producing a large amount of excited fluorescence.

After the sample is added to the reagent, the borate-fluorophore competes with hemoglobin for binding, resulting in a decrease in fluorescence. Because the binding force of unglycated hemoglobin is much greater than that of glycated hemoglobin, the unglycated hemoglobin first binds to the borate-fluorophore, resulting in a sharp drop in fluorescence. The content of unglycated components can be detected during this process.

Next, the glycosylated hemoglobin is bound to a borate-fluorophore. This binding process is slow and therefore the fluorescence quenching process is slow and curvilinear. The fluorescence quenching process in the detection cycle of the instrument can reflect the content of glycosylated hemoglobin.

Feature

• Boronate affinity Method: The HbA1c assay has no interference from common Hb variants

• Ease of use: One-step operation the instrument is ready for use.

• Less than 3-minute test time

• A compact, lightweight instrument, Compact Size - To Minimize Space Requirements.

• With no need for bulky liquid reagents, LD-100 also free up more space in laboratories, clinics, blood banks, and other situations.

• Traceable to the IFCC Reference Method for HbA1c；Results reporting unit: IFCC units (mmol/mol) and NGSP units (%%).

Performance Parameters

• Accuracy: Is tested with the reference material as samples, and the relative deviation of the determination results of the analyzer should be within the range of ±8%.
• Precision:Samples with a concentration of 4.0%-6.5% are detected, sample coefficient of variation (CV) of the test results is not more than 3%.
• Linearity:In the range of 4%-15% of HbA1c, the linear correlation coefficientrof the test results should be no less than 0.9900.
• Stability:Within 8 hours after the instrument is turned on and stable, the relative deviation of the test results is not more than ±3%.
• Functions of the analyzer:The function of report output in English; Abnormal alarm function.

Certificate