HPLC Method POCT HbA1c Analyzer Excellent Performance Full Automated HbA1c Analyzer

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

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.