Hotgen Pioneers a New Era of Small Molecule Sandwich Method Diagnostics

With the continuous advancement of medical technology, the field of in vitro diagnostics (IVD) has also ushered in new revolutionary breakthroughs. The small molecule double antibody sandwich method, as an innovative detection technology, is gradually replacing traditional competitive methods and playing an increasingly important role in various detection projects. Hotgen, as an industry leader, has upgraded its thyroid function, hormones, vitamins, and other detection projects to the small molecule double antibody sandwich method and plans to launch more innovative products based on this technology in the future. This initiative not only enhances the precision and sensitivity of the detection but also provides more efficient and economical solutions for a wide range of medical institutions and patients.

Advantages of the Small Molecule Double Antibody Sandwich Method

Compared with the traditional competitive method, the small molecule double antibody sandwich method has many significant advantages. First, it can provide higher detection sensitivity, making the detection of low-concentration samples more accurate and reliable. Second, the sandwich method has a wider linear range, which means that it can detect target molecules over a broader concentration range, thereby improving the adaptability of the detection. Additionally, the sandwich method can offer better specificity, reducing the interference of cross-reactions and ensuring the accuracy of the detection results. With these advantages, the small molecule double antibody sandwich method is playing an increasingly important role in detecting various hormones, vitamins, cardiac, and cancer markers.

Hotgen's innovations in this field have already yielded noticeable results. Hotgen's thyroid function, hormones, vitamins, and other detection projects have successfully been upgraded to the small molecule double antibody sandwich method, with more projects set to upgrade based on this technology in the future. We are committed to providing the medical industry with more efficient and accurate diagnostic tools to meet clinical and patient needs through technological innovation.

Compliance with New EU Regulations: Hotgen Obtains International Certification

With the introduction of the new in vitro diagnostic (IVD) regulation — (EU) 2017/746 (IVDR) by the European Union, certification and regulatory standards for in vitro diagnostics products have become more stringent. According to this regulation, all in vitro diagnostic medical devices must meet stricter safety, quality, and efficacy requirements. Starting from May 26, 2022, the IVDR will be fully applicable across the European Union.

Hotgen greatly emphasizes product safety and quality, has obtained certification in compliance with the IVDR, and has successfully certified 93 new products, including cardiac, hormone, inflammation, and cancer markers. This not only signifies Hotgen's firm commitment to the quality and safety of diagnostic products but also demonstrates our profound attention and commitment to the needs of healthcare professionals and patients. By obtaining IVDR certification, Hotgen's products are qualified to enter the EU market, laying the foundation for providing high-quality diagnostic products to global users.

Leading Future Development with the Small Molecule Double Antibody Sandwich Method

Hotgen's small molecule double antibody sandwich method has achieved its first CE IVDR certification for single-detection CLIA (chemiluminescence immunoassay) and up-converting phosphor technology (UPT). This certification marks another milestone for Hotgen in promoting high-precision immunodiagnostics in the international market. With innovative technology, Hotgen has not only achieved accuracy and cost-effectiveness in small molecule diagnostics such as vitamins and hormones but has also propelled more efficient diagnostic products to the global market.

In the future, Hotgen will continue to innovate in the field of the small molecule double antibody sandwich method, further expanding our product line to cover more detection projects. We always adhere to the principles of precision, economy, and flexibility, dedicated to providing high-quality diagnostic products for global medical institutions. Our products have been recognized and used by more than 10,000 medical institutions worldwide. Hotgen will continue to strengthen research and development to provide more innovative in vitro diagnostic products to meet the ongoing needs of the global market.

Hotgen's Global Vision

As an important player in the global in vitro diagnostics industry, Hotgen has always been at the forefront of precision diagnostic technology. Through continuous technological innovation and product optimization, Hotgen has obtained registrations and certifications in multiple countries and regions worldwide. We are confident that in the near future, more Hotgen diagnostic kits will be registered and recognized in the EU and globally. We will continue to promote the widespread application of the small molecule double antibody sandwich method and other innovative technologies in the global medical diagnostics field, safeguarding the health of patients worldwide.