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