Opu Bio has been approved for marketing. The O-HbA1c glycated hemoglobin quantitative detection kit (latex enhanced immune turbidimetry) independently developed by Aop Bio has successfully obtained the product registration certificate. Registration certificate number: Shanghai Mechanical Note 20162400480.
Glycated hemoglobin is of great significance in diabetes monitoring. Its concentration is parallel to the blood sugar value and is not interfered by short-term blood sugar fluctuations. It can well reflect the degree of blood sugar control over a longer period of time. The O-HbA1c kit is used in conjunction with the fully automatic specific protein point-in-time detection analyzer (i.e. Ottoman) produced by Opp Biotech that has obtained the medical device registration certificate, and is used for in vitro quantitative determination of glycated hemoglobin content in whole blood samples by medical institutions. , for auxiliary diagnosis.
The O-HbA1c kit has the following significant advantages compared with registered products on the market: whole blood samples can be loaded directly onto the machine without pre-processing, with higher sensitivity and specificity, shorter detection time, and stability It has good properties and overcomes the problem of easy precipitation of reagents on the market. This product was successfully approved for marketing, which not only filled the gap in the product line of Aopu Biotechnology, but also filled the gap in domestic POCT technology products.
The O-HbA1c kit has been clinically tested in Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Zhongshan Hospital Affiliated to Fudan University, with Bio-Rad HPLC systems. The hospital’s clinical research results have the following evaluation of the kit :
1 When measuring EDTA anticoagulated venous whole blood samples, the correlation is good with the generally recognized and reliable comparison method, and the systematic deviation is within the allowable range. The comparison regression equation y = 0.998x + 0.019, n=207, the linear regression coefficient is 0.994, and the correlation coefficient R=0.9935.
2 When measuring peripheral blood samples, the correlation is good with the generally recognized and reliable comparison method, the systematic deviation is within the allowable range, the comparison regression equation y = 1.044x -0.318, n=30, linear The regression coefficient is 1.044, and the correlation coefficient R=0.990.
3 Triglycerides at 12mmol/L, total bilirubin at 500umol/L, and rheumatoid factor at 500IU/ml have no interference in the determination of O-HbA1c within the range of 50mg/dl. The glycated hemoglobin quantitative detection kit produced by Aopu Biotech uses the latex-enhanced immunoturbidimetric method, which is cleverly combined with the supporting detector. It is simple, fast, reproducible, and has the specificity of the monoclonal antibody immunological method. The latex-enhanced immunoturbidimetric method is not affected by commonly used clinical anticoagulants, nor is it interfered by exposure to high concentrations of urea, high triglycerides, high bilirubin, high concentrations of glucose, changes in hematocrit ratio, and high chylomicrons , the recovery rate and coefficient of variation are within the allowable range, it can perform automatic, rapid, and continuous analysis, and has extensive clinical application value, so it is selected as one of the routine detection methods in clinical practice.