Glycosylated hemoglobin is of great significance in diabetes monitoring. Its concentration is parallel to the blood sugar value, and it is not disturbed by short-term blood sugar fluctuation, which can well reflect the degree of long-term blood sugar control. The O-HbA 1c kit is used in conjunction with the automatic real-time detection analyzer (Automan) produced by Aopu Bio, which has obtained the medical device registration certificate, for medical institutions to quantitatively determine the content of glycosylated hemoglobin in whole blood samples in vitro for auxiliary diagnosis.
Compared with the registered products in the market, the O-HbA 1c kit has the following obvious advantages: the whole blood sample is placed directly on the computer without pretreatment, with higher sensitivity and specificity, shorter detection time and good stability, which overcomes the phenomenon that reagents are easy to precipitate in the market. The successful listing of this product not only fills the blank of Opal's biological product line, but also fills the blank of POCT technology in China.
O-HbA 1c kit was tested in Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, Zhongshan Hospital affiliated to Fudan University and Bole HPLC system. According to the clinical research results of the hospital, the kit was evaluated as follows:
1 has a good correlation with the recognized and reliable comparison method in the determination of EDTA anticoagulated venous whole blood samples, and the systematic deviation is within the allowable range. The regression equation y = 0.998x+0.0 19, n=207, the linear regression coefficient is 0.994, and the correlation coefficient R=0.9935.
2. When determining the peripheral blood samples, the correlation with the recognized and reliable comparison method is good, and the systematic deviation is within the allowable range. The regression equation y = 1.044x -0.3 18, n=30, the linear regression coefficient is 1.044, and the correlation coefficient R=0.990.
Triglyceride 12mmol/L, total bilirubin 500umol/L and rheumatoid factor 500IU/ml did not interfere with the determination of O-HbA 1c in the range of 50mg/dl. The quantitative detection kit of glycosylated hemoglobin produced by Aopu Biotechnology adopts latex enhanced immunoturbidimetry and is ingeniously combined with the matched detector, which has the characteristics of simple, rapid, good repeatability and strong specificity of monoclonal antibody immunoassay. Latex-enhanced immunoturbidimetry is not affected by common anticoagulants, high concentration of urea, triglyceride, bilirubin, glucose, hematocrit and chylous particles. The recovery rate and coefficient of variation are within the allowable range, which can be analyzed automatically, quickly and continuously, and has wide clinical application value. Therefore, it was selected as one of the routine clinical detection methods.