POCT For HbA1c Analyzer Ues Various Hemtology Analyzer testing Kit Hemoglobin A1c Test Kits

Intended Use

The Hemoglobin A1c Test Kits (Boronate Affinity) (herein after referred to as kits) adopt the principle of boronate affinity to use with the LD-100 POCT HbA1c Analyzer to detect the content of glycosylated hemoglobin in the human whole blood samples, mainly for diagnosis of diabetes and monitoring of blood glucose level in clinical practice

Main Components

• Test Cartridge (separately packaged in aluminum foil bag with a silica gel indicating bag)
• Sample Collector
• RFID Card

Use Step

1. Push the bead containing the fluorescence borate conjugate into the buffer solution of the test cartridge.
2. The bead is mixing for full dissolution in the test cartridge.
3. Insert the sample collector with the blood sample into the buffer solution and mixed to release the hemoglobin in the red blood cells.
4. The combination of fluorescence borate conjugate and HbA1c is detected by the analyzer by testing the decrease of fluorescence active components, and the ratio of glycosylated hemoglobin to total hemoglobin could be determined.

Interpretation Of Test Result

• Samples beyond the linear range couldn’t be detected by dilution way.
• This test is used to assess the control degree of diabetes. The proportion of HbA1c could reflect the average blood glucose level in the first 2-3 months before measurement and this test has become a good indicator to reflect the long-term blood control level of diabetes.
• HbA1c level below the reference range may indicate a recent hypoglycemic episode, the presence of Hb variants or a short erythrocyte lifespan and any cause for shortening the erythrocyte lifetime will reduce the time of erythrocyte exposed to glucose with a subsequent decrease of HbA1c%, even though average blood glucose levels may be elevated for that time. Hemolytic anemia or other hemolytic diseases, sickie cell characteristics, pregnancy, recent significant blood loss or chronic blood loss etc. may account for the shortened life span of erythrocyte. When explaining HbA1c results of these patients, they can’t be measured in the normal reference range.
• The test result will not be affected by unstable HbA1c and the following glycosylated variants as HbAS, HbAC, HbAD, HbAE, HbAJ, HbSS, HbCC, HbSC and elevated fetal hemoglobin (up to 6%).

Test Limitation

• The test shouldn’t be used to determine day to day glucose control nor replace daily home tests for urine or blood glucose.
• The test result is only one of the indicators for clinician to diagnose patients and the clinician should judge comprehensively according to patents’ physical signs, medical history and other items and diagnostic methods.

Attention Items

• This product is only used for in vitro diagnostics.
• Quality control products, calibration products and samples should be treated with caution as potential sources of infection and experimental wastes should be disposed in accordance with local law and regulations.
• The kits contain preservatives not touched directly, rinse with plenty of water when accidentally touching or putting into eyes and seek medical advice immediately if feeling unwell.
• The kits should be stored as required, used within validity and shouldn’t be mixed with different batches.
• The quality control products should be inserted into each batch to ensure the quality.
• The performance index of the above products are measured by LD-100 POCT HbA1c analyzer, which is only for reference when using other instruments.

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.