Glycosylated Hemoglobin Measuring Device POCT HbA1c Analyzer

Glycosylated Hemoglobin Measuring Device POCT HbA1c Analyzer is intended for measuring glycoslated hemoglobin (HbA1c) in human blood.

It is applicable to the quantitative detection of HbA1c in venous blood in EDTA test tube.

According to the most recent IDF data, 537 million people—approximately 10% of all people aged 20-79 in the world—were living with diabetes as of 2021.

With the development of modern medicine, people pay more and more attention to their own health and the diagnosis and control of diabetes has become a hot topic. As we know, diabetes is a group of metabolic diseases characterized by hyperglycemia. Every Patient with diabetes is adviced to have their HbA1c tested for 2-4 times annually.

The analyzer works based on the principle of boronate 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.

Specification

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 Indicators

• Accuracy: The accuracy shall be measured with reference materials as samples, and the relative deviation of the results measured by the analyzer shall be less than ±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

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.