In Vitro Diagnostic Industry in China - Clinical Chemistry VII

2.2.3 Creatinine Assay Kit (Creatine Oxidase Method)

​Maccura obtained the registration certificate of this product and was granted the invention patent in 2018. It is the first creatinine assay kit for anti-drug interference. Creatinine, as the most basic index for clinical evaluation of renal function, is widely used in the diagnosis and treatment monitoring of various chronic kidney diseases and acute kidney injury. However, for a diabetic patient, the administration of calcium dobesilate will produce serious negative interference to the subsequent creatinine test results, which generally exists in the testing products and methods of medical institutions at all levels, hides the actual condition of the patient, and delays the correct treatment of the patient, resulting in a very high medical safety risk. This product can guarantee the reliable and accurate results of the subsequent creatinine tests for the majority of patients who are taking calcium dobesilate.

2.2.4 Prostate-Specific Antigen Assay Kit (Latex Immunoturbidimetry)

BSBE obtained the registration certificates for PSA && FPSA assay kit in 2014 and 3020, respectively, which are the first domestic platform for rapid detection of SA & PSA. This product is used to quantitatively detect the content of total prostate-specific antigen in vitro in human serum for the dynamic monitoring of malignant rumor patients, so as to assist in assessing the disease progression or treatment effect. The detection sensitivity of fPSA reagent can reach the level of chemiluminescence, which is suitable for fully automatic biochemistry analyzers for fast testing in batches, effectively reducing the user costs.

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