In Vitro Diagnostic Industry in China - Clinical Chemistry VI

2.2.1 Creatine Kinase Isoenzyme Assay Kit (Latex Immunoturbidimetry)

BSBE is the first company that has obtained a registration certificate for the CK-MB mass determination on the biochemical platform and an invention patent at the end of 2018.

In principle, the CK-MB mass determination is to directly identify the CK-MB using the monoclonal antibody; the specificity of the antibody avoids the influence of giant CK and adenylate kinase on the test results, and solves the problem of the sample inversion in the immunosuppression method of the original biochemical platform. In addition, the antibody has better stability, which ensures the accuracy of the test results. All performance indexes can meet the clinical needs, and the performance is comparable to that of imported chemiluminescence products, which saves the user's cost and provides reliable quality assurance for laboratory testing.

2.2.2 Glutathione Reductase Assay Kit (Latex Immunoturbidimetric Assay)

Jiangxi Lecheng obtained the registration certificate for this product in 2017 and was granted an invention patent. Serum glutathione reductase is highly sensitive to the early stage of acute hepatitis. Clinical studies have shown that the Serum glutathione reductase reached the peak values earlier than the transaminase in the early stage of acute hepatitis, which can be used for the identification of early liver injury and the detection of malignant disease, nutritional assessment, and hereditary deficiency disease. The product adopts the dual liquid regent mode with a high accuracy, which can eliminate the influence of sample blanks (fat turbidity, hemolysis, jaundice, and other interfering substances), cuvette, etc., and the reagents are stored separately to improve the stability of the reagents.

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