New product express! WESAIL received 7 medical device product registrations (in vitro diagnostic reagents)

Release time:

2023-08-28 15:48


Guangdong Weishi Biotechnology Co., Ltd. has 3 categories of myocardial, inflammatory and renal function, with a total of 7 products obtained on November 10, 2021.Product Registration Certificate for Medical Devices (In Vitro Diagnostic Reagents) issued by Guangdong Provincial Drug Administration. With the previously certified supporting fluorescence immunoassay analyzer, can be officially sold in China. The certified products include:


Hypersensitive cardiac troponin I(hs-cTnI) detection kit (immunofluorescence method)

Creatine kinase isoenzyme (CK-MB) detection kit (immunofluorescence method)

Myoglobin (Myoglobin) detection kit (immunofluorescence method)

Interleukin-6 (IL-6) detection kit (immunofluorescence method)

Serum amyloid A(SAA) detection kit (immunofluorescence method)

Full C- reactive protein (hs-CRP CRP) detection kit (immunofluorescence method)

Urinary microalbumin (MAU) detection kit (immunofluorescence method)



Brief description of certified products


myocardial products


1. Hypersensitive cardiac troponin I(hs-cTnI) detection kit (immunofluorescence method)


Troponin I is a key regulatory protein of striated muscle tissue and is associated with muscle contraction. There are three subtypes of troponin found at present, among which cardiac troponin I(cTnI) has a high degree of myocardial tissue specificity and can distinguish skeletal muscle lesions from myocardial damage. It is unanimously rated as a high-specificity and high-sensitivity diagnostic marker for acute myocardial infarction by the American and European Heart Associations. It is currently recognized as the "gold standard" for myocardial infarction diagnosis, while the sensitivity of hypersensitive troponin I can reach 0.02ng/mL, for patients with myocardial injury without ECG changes and typical clinical symptoms, the best auxiliary diagnostic index of myocardial injury can be found earlier. Only real biological hypersensitive cardiac troponin I(hs-cTnI) detection kit (immunofluorescence method) is suitable for direct detection of whole blood, serum and plasma samples, with a minimum detection limit of 20pg/mL, a normal detection rate of ≥ 50%, and the results can be reported in only 8min.


2. Creatine kinase isoenzyme (CK-MB) detection kit (immunofluorescence method)


Creatine kinase isoenzyme (CK-MB) mainly exists in myocardium, which is one of the important markers of serum enzyme spectrum in the diagnosis of myocardial infarction. When acute myocardial infarction (AMI) occurs, CK-MB is released into the blood, begins to increase at 4-6 hours, reaches a peak concentration at 10-24 hours, and returns to normal levels within 48-72 hours. When the blocked myocardial coronary artery is recanalized, the CK-MB in the myocardial cells will be washed out by the blood flow, resulting in an increase in CK-MB. The effect of thrombolytic therapy can be evaluated according to the change of CK-MB concentration. Therefore, CK-MB can be used as an auxiliary diagnostic index to evaluate the degree of myocardial injury, the effect of thrombolytic therapy, the scope of re-embolization or embolization and the risk classification.


3. Myoglobin (Myoglobin) detection kit (immunofluorescence method)


Myoglobin (Myoglobin) is a unique protein in muscle tissue. Oxygen is supplied to give energy when muscle movement requires energy. In acute myocardial injury, Myoglobin is first released into the blood. After symptoms appear for about 1-3 hours, blood Myoglobin can exceed the upper limit of normal, reach a peak in 6-9 hours, and return to normal after 24-36 hours. Patients with chest pain are continuously monitored for 2 to 12 hours of Myoglobin concentration, and acute myocardial infarction (AMI) can be ruled out if the concentration is not elevated. Therefore, continuous detection of Myoglobin levels can be used for early diagnosis of AMI, with a good exclusion significance.


Inflammatory products


1. Interleukin-6 (IL-6) detection kit (immunofluorescence method)


Interleukin-6 (IL-6) is a cytokine, belonging to a class of interleukins, that stimulates the proliferation, differentiation and function of cells involved in the immune response. IL-6 and its receptors are associated with inflammatory diseases. It is a multifunctional inflammatory cytokine and plays an important role in the inflammatory response. Elevation of IL-6 occurs earlier than other cytokines in the inflammatory response, so IL-6 are early warning indicators of susceptibility to SIRS sepsis caused by general bacterial infection or systemic inflammatory response.


2. Serum amyloid A(SAA) detection kit (immunofluorescence method)


Serum amyloid A(SAA) is an acute phase response protein, a highly heterogeneous class of proteins in the apolipoprotein family. SAA has superior sensitivity to CRP in the diagnosis of inflammatory reactions or infections. In normal human serum, its content is extremely small. In the case of bacterial infection and viral infection, SAA is synthesized by activated macrophages and fibroblasts in the liver stimulated by IL-1, IL-6 and TNF, which can increase to 100-1000 times of the original concentration. However, the half-life of SAA is short, only about 50 minutes, and the level of SAA in viral infection is significantly increased. SAA combined with CRP detection, the type of infection of infectious diseases can assist in the differential diagnosis.


3. Full C- reactive protein (hs-CRP CRP) detection kit (immunofluorescence method)


C- reactive protein (C-reactive protein,CRP) is a non-specific acute phase reactive protein, its content in normal human serum is minimal, the body in a variety of inflammatory processes, tissue necrosis and tissue damage (such as surgery) and other pathophysiological conditions, the release of inflammatory cytokines such as IL-6 resulting in increased serum CRP concentrations. The determination of CRP not only helps to assess trauma, infection, inflammation and other related diseases, but also helps to assess the risk of cardiovascular disease. The Centers for Disease Control and the Heart Association (CDC/AHA) have developed CRP cardiovascular disease risk assessment guidelines for this purpose. CRP is a non-specific indicator, and when CRP levels are elevated, it needs to be explained in conjunction with the clinical history.



Kidney function products


Urinary microalbumin (MAU) detection kit (immunofluorescence method)


Microalbuminuria (MAU) is the presence of trace amounts of albumin in the urine. Albumin is a normal protein in the blood. Under normal human metabolism, there is very little albumin in the urine, and trace proteins basically cannot pass through the filtration barrier. Once the integrity of the glomerulus is damaged, the filtration of trace proteins increases, and Proteinuria occurs. In clinical practice, trace protein indicators are usually used to monitor the occurrence of kidney disease, and the disease can be diagnosed more accurately by the value of urine microalbumin, combined with the incidence, symptoms and medical history. In addition, microalbumin is one of the earliest objective indicators of glomerular microangiopathy induced by diabetes, and is an important indicator of diabetic nephropathy.


WS-Si1000 with single channel fluorescence immunoassay analyzer


The adapted single-channel fluorescence immunoassay analyzer WS-Si1000 simple and intelligent operation, high low-value detection accuracy, simple and clear UI interface, and humanized interaction. The difference between machines is less than or equal to 3%, the stability is less than or equal to 1%, and the performance is comparable to imported chemiluminescence instruments.




Next, there will be more products, more full package products and services to customers, so stay tuned.


In accordance with the requirements of drug regulatory departments at all levels, WESAIL will, as always, strictly control the quality, continuously consolidate the foundation of technological innovation, accelerate the realization of product breakthrough and upgrade, and further add new vitality to the domestic in vitro diagnostic industry!


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