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We are pleased to announce that our Autobio Human Immunodeficiency Virus Antibody and Antigen (p24) Combined Test Kit (Magnetic Particle Chemiluminescence) and Hepatitis C Virus Test Kit (Magnetic Particle Chemiluminescence) have successfully passed the European Clinical Examination, and have been awarded CE IVDR Class D certificates of the highest risk level by the EU Notified Body - TÜV SÜD. TÜV SÜD, the EU Notified Body, issued the highest risk CE IVDR Class D certificate.

A CE certificate is required for products to enter the EU market. Within the context of in vitro diagnostic medical treatment, the CE IVDR regulation classifies products according to their risk level, from Class A to Class D. CE IVDR Class D represents the highest level of certification, requiring not only the establishment of a robust quality system by the applicant company, but also the completion of product performance verification by a third-party independent laboratory in Europe. This verification process involves a comparison of the results with those of leading products within the current technological level. Post-certification, in addition to the regular annual audit and supervision of each product batch in the EU authoritative laboratory batch testing, a higher frequency of flight inspection is required compared to other products.Human immunodeficiency virus (HIV) infection is a worldwide public health problem. HIV can damage the immune system, reducing the body's ability to resist infection and disease. The HIV p24 antigen can be detected as early as 2-3 weeks after infection, while HIV antibodies can be detected after about 4 weeks. The combination of HIV p24 antigen and HIV antibodies can shorten the diagnostic window period, facilitating early diagnosis and treatment of HIV.

Hepatitis C virus (HCV) is a single-stranded RNA virus that causes viral hepatitis C, which can lead to chronic inflammation, necrosis and fibrosis of the liver. It is currently showing a global epidemic trend and is a serious public health problem.Hepatitis C is mainly transmitted through blood, so early and accurate diagnosis is an effective means of blocking the transmission pathway and ensuring timely treatment.

Autobio's Human Immunodeficiency Virus Antibody and Antigen (p24) Combination Test Kit (Magnetic Particle Chemiluminescence), Hepatitis C Virus IgG Antibody Test Kit (Magnetic Particle Chemiluminescence), and Hepatitis B Virus Surface Antigen (HBsAg) Test Kit (Magnetic Particle Chemiluminescence) have been awarded the highest European Union risk level CE IVDR Class D certificate.

Autobio is committed to the popularisation and improvement of medical laboratory technology, and serves for human health. The company constantly enriches the product line to provide more abundant products and services for international customers.