POCT Reagents of hs-cTn

High-sensitive cardiac troponin (hs-cTn) refers to the determination of cTn by a highly sensitive method. It was originally thought that cardiac troponin (cTn) was released into peripheral blood and detected after myocardial cell damage and destruction. Now a new generation of highly sensitive methods has been able to detect cTn (possibly related to the metabolism of cardiomyocytes) in a considerable part of apparently healthy people. This will help to detect small myocardial damage that was easily missed in the past, diagnose AMI earlier, screen patients at high risk of cardiovascular events (diseases) more reasonably, and optimize clinical treatment decisions and prognosis evaluation.

The cTn detected by the highly sensitive method is called hs-cTn detection. It was defined as being able to detect cTn in more than 50% of apparently healthy men and women with an imprecision (CV) of 99th URL detection ≤10%. The 2019 Guidelines for Diagnosis and Treatment of Acute Coronary Syndrome clearly stated that qualified medical institutions should prefer hs-cTn detection: if the first test result is not increased (negative), blood should be collected again at intervals of 1-3 hours and compared with the first result ; If the second test result exceeds the 99th URL and increases by more than 20%, acute myocardial injury is considered; if the initial two test results are still inconclusive and the clinical possibility of ACS is highly suspected, the test should be repeated 3-6 hours later.

Since the lowest limit of detection (LoD) of hs-cTn is reduced to 1/100~1/10 of that of traditional cTn, the accuracy of the diagnosis of myocardial injury in the first blood draw during emergency department visits is greatly improved. The negative predictive value (NPV) of a single hs-cTn detection value for myocardial infarction is > 95%, and some studies have shown that the sensitivity of 2 hs-cTn detection within 3 hours of symptom onset can reach 100% for the diagnosis of myocardial injury; therefore, For patients who seek medical attention within 3 hours from the onset of the disease, it is recommended to use the 0/1 h, 0/2 h and 0/3 h diagnosis and treatment procedures of hs-cTn to diagnose or exclude AMI, but it should be noted that the boundary value of the algorithm (cut-off value) should correspond to the detection system used; the methodology used is different, and the thresholds are also different.

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Zecen Biotech CO., LTD., founded in 2011, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents. Zecen focus on the Chemiluminescent immunoassay (CLIA) field. With all products CE marked, our market presence currently spreads from across China to other countries including India, Switzerland, Russia etc., Zecen is expanding its footprint to become a global brand.

Zecen is the only enterprise with independent intellectual property rights in the entire chemiluminescence industry chain in China, including reagent, instrument, magnetic microbead, and reagent raw material. Our current products include more than 100 assays, from thyroid, inflammation, diabetes, tumer markers, immune disorders, hormones to cardiac markers. Our ever-expanding test menu helps our customers and collaborators keep up with the demands of healthcare sector. Zecen is striving for innovation and perfection to deliver the best products to the customers.

As a manufacturer, Zecen provide the OEM, ODM and other customized service of all products. We have the core R&D centers and innovative ability to lay a solid foundation for developing the broadest range of CLIA analyzers and test menu. High-quality sales and after-sales links provide the more intimate service. The patent and CE certification give us the confident sending all over the world, and more than 50 companys in the requiement of customized and have a long term coorperation with Zecen.