LD-560 HbA1c Analyzer HPLC Method Excellent Performance Full Automated HbA1c Analyzer IFCC Certificated

Intended Use

The Fully Automated HbA1c Analyzer is used in conjunction with suitable reagents for the quantitative detection of glycosylated hemoglobin

(HbA1c) in human blood.

Principle

Using high performance liquid chromatography (HPLC), the stationary phase used is a weakly acidic cation exchanger. Glycosylation of hemoglobin will result in the loss of cations on the surface of hemoglobin without being charged, and non-glycosylated hemoglobin has a positive charge.

Performance Parameteras

• Reporting unit: Glycosylated hemoglobin (HbA1c) is reported in NGSP (%) and IFCC units (mmol/mol).
• Accuracy: The accuracy is tested with reference materials as samples, and the relative deviation of the
• test results should be within ± 5%.
• Repeatability: For samples with a test concentration of 4% 6%, the sample coefficient of variation (CV)
• of the test results is not greater than 2.0%.
• Linear range: Within the range of 3% 18% of glycosylated hemoglobin, the linear correlation coefficien t
• R value of the test results should not be less than 0.9900.
• Stability: Within 8 hours after the analyzer is turned on and stabilized, the same normal sample is tested, and the relative deviation of the test results is not more than ±3.0%.
• Carrying pollution: The carrying pollution rate of the analyzer should not be greater than 2.0%.
• Basic function: Provides Chinese report and abnormal alarm.
• The temperature accuracy and fluctuation of the chromatography column module: the temperature is within ±1°C of the set value, and the fluctuation is not more than 0.8°C.

Reagents and Consumables

• Eluent A/Eluent B/Eluent C: Adjusts the pH of the solution for the elution of glycosylated hemoglobin and non-glycated hemoglobin.
• Hemolysis Reagent: Used to dissolve red blood cells and release hemoglobin.
• Chromatography column: Used for separation and elution of glycosylated hemoglobin and non-glycated hemoglobin.
• Filter: Used to initially filter the sample after hemolysis.
• Paper Rolls: Prints a report of the test results.

Application Scenarios

• Primary Medical Institutions
• Women’s and Children's Hospitals
• Diabetes Specialist Hospitals
• Elderly Care Institutions
• Laboratory

Certificate