The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, lateral flow membrane based immunoassay for the detection of CK-MB in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-CK-MB antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with capture reagent on the membrane and generate a colored line. The presence of this colored line in the test line region indicated a positive result, while its absence indicated a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.  Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa. Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CKBB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue. The release of CK-MB into the blood following MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours. CK-MB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of MI. The CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti-CK-MB antibody coated particles and capture reagent to detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/mL.

Zhejiang Orient Gene Biotech Co., Ltd specializes in the R&D, production, and sales of in vitro diagnostic products in the field of high-end medical equipment and devices.
Currently, its main products are POCT instant diagnostic reagents, which are mainly used in the detection of infectious diseases (including COVID-19 detection products), drugs of abuse, fertility, tumor marker and cardiac marker detection, among which infectious disease and drugs of abuse detection are the two core product series of the company.
The company’s sales network has been extended to more than 120 countries and regions, and its overseas sales revenue accounted for 95% in 2019. At present, the company has obtained more than 300 overseas certifications/records, and more than 70 domestic registration/record certificates.