Automated Hematology Analyzer For HbA1c Diaglosis IFCC & NGSP Certified

Using high performance liquid chromatography (HPLC), the stationary phase used is a weakly acidiccation 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. According to the different charged properties of hemoglobin, eluents with different pH values and ionic strengths are used sequentially, and several hemoglobin components including HbA1c are separated by high performance liquid chromatography. Each component is detected by a single wavelength colorimeter, and the detected data is processed by a computer to calculate the percentage content of HbA1c in the total hemoglobin.

Basic Parameters

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Test modes: Whole blood and pre-dilute modes

Blood sampling volume: The sampling volume of whole blood samples shall not be less than 1.5ml. The EDTA K2 is the recommended anticoagulant.

Test specimen volume: 5ul in whole blood mode; 150ul in pre dilution mode.

Dilution ratio (pre dilution mode): Whole blood: Hemolysis = 1:300 (5ul W hole blood + 1500ul Hemolysis)

Analysis wavelength: 420nm.

Performance Parameters

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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 coefficient 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.

Product Composition

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Main Parts

The analyzer consists of an auto sample injection module, a liquid chromatography separation module, a colorimetric detection and control module, a barcode scanning module, and a display printing module.

Reagents and Consumables

The analyzer is recommended to be used in conjunction with the Glycosylated Hemoglobin Test Reagent Kit (high performance liquid chromatography (HPLC method)) produced by our company, which includes the following components:

Eluent A/Eluent B/Eluent C(Variant Mode)	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.

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.