Glycosylated Hemoglobin (HbA1c) Assay Kit – Bulk Reagents

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Selling unit: per 100ml

Product Name

Common name: Glycosylated hemoglobin (HbA1c) assay kit (latex-enhanced immunoturbidimetric method)

English name: Hemoglobin A1c(HbA1c) Assay Kit (Immunoturbidimetric Method)

Reagent Ratio

3:1

Intended Use

This kit is used for the in vitro quantitative determination of HbA1c in human whole blood.

HbA1c is a product of the non-enzymatic reaction of hemoglobin with glucose. Glucose specifically modifies hemoglobin at the valine residue at the N-terminus of the hemoglobin beta chain to form HbA1c, the concentration of which correlates with the average blood glucose level over the life cycle of red blood cells. Therefore, HbA1c is a good indicator of a patient’s average blood glucose level over a 2-3 month period.

Test Principle

The determination of HbA1c is a method for direct determination of the percentage of HbA1c in total Hb using antigen and antibody reactions. Total Hb and HbA1c in the sample are solidified by the same non-specific adsorption with latex, and when a specific monoclonal antibody to HbA1c is added a complex of latex-HbA1c-mouse anti-human HbA1c monoclonal antibody is formed, and this complex forms an agglutination due to the sheep anti-mouse antibody, and the amount of agglutination varies depending on the amount of The amount of agglutination varies depending on the amount of HbA1c solidified on the latex surface. The absorbance was measured and compared with the standard curve of HbA1c percentage concentration to find the percentage of HbA1c in the sample.

Main Components

Reagent components included in the product.

Glycosylated Hemoglobin (HbA1c) Assay Kit & Bulk Reagents

*Components are not interchangeable in kits with different lot numbers.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents R1 and R2 are stable for one month when opened and stored at 2-8°C away from light.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.

Sample Request

Fresh whole blood anticoagulated with sodium fluoride, EDTA or heparin.

Sample processing: Use anticoagulated whole blood, take 10μL of sample and add 1mL of hemolysin for hemolysis. The hemolyzed samples can be stored at room temperature and protected from light (15~25℃) for 3 days, at low temperature and protected from light (2~8℃) for 7 days, and at -20℃ and protected from light for 6 months.

Test Method

  1. Reagent preparation

Liquid reagents are ready to use right out of the bottle.

  1. test conditions: (different test instruments can be requested according to the different parameters on the machine)

Glycosylated Hemoglobin (HbA1c) Assay Kit & Bulk Reagents

Operation steps.

Glycosylated Hemoglobin (HbA1c) Assay Kit & Bulk Reagents

Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. Calibration procedure.

Calibration is performed using the matching calibrator.

  1. quality control control procedures

It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. Calculation.

5-point calibration, tube ① was taken from distilled water and the input value was 0.00g/L, tubes ② to ⑤ were taken from calibration serum and the corresponding values were input. The standard curve is plotted with △A as the vertical coordinate and the concentration as the horizontal coordinate, and the standard curve is corrected by the non-linear method Spline mode, and this standard curve is saved and used to calculate the results. The reagents of different batches must be re-calibrated.

Positive Judgment Value Or Reference Interval

Non-diabetic: 3.0-6.0%

Diabetes in control: 6.0-9.0%

Uncontrolled diabetes: >20%

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

The HbA1c measurement in human whole blood is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

Limitations Of The Test Method

Bilirubin ≤ 40 mg/dL and celiac ≤ 300 mg/dL did not interfere with the determination.

Product Performance Index

Absorbance of reagent blank: wavelength 660 nm, optical diameter 1.0 cm, temperature 37℃, A≤1.0.

Analytical sensitivity: The absorbance change rate ΔA/min≥0.05 when the kit tests 6% of the measured substances.

Linearity interval: reagent linearity in the interval from 2% to 14%, the linear correlation coefficient|r| should be not less than 0.975; in the interval from 2% to 5%, the absolute deviation of linearity should not exceed 0.5%; in the interval from (5%- 14%, the relative deviation of linearity should not exceed ±10%.

Precision: repeatability CV≤8%; relative extreme difference between batches≤10%.

Accuracy: Relative deviation ≤ 10%.

Caution

  1. 1. This product is for in vitro diagnostic use only, please follow the instructions for proper use.
  2. 2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. 3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
  4. 4. Do not mix R1 and R2 into a single reagent, or exchange reagents with different lot numbers.
  5. 5. When changing the reagent lot number, please recalibrate.

Reference

  1. Tietz NW et al. ClinChem (1983), 29 (5): 751
  2. Tietz NW et al. ClinChemActa, (1983), 135: 339
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