2020-04-30
According to a report by Rai Italia, a SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal Gold) supplied by TGS, a subsidiary company of Kehua Bio-engineering (KHB), is extensively used in test centers in Campania, Italy.
A report by Xinhua News Agency from Rome on April 26 said that Prof. Vittorio Sambri, an Italian medical expert at Università di Bologna, expressed his positive opinion on the medical products made in China, including diagnostic test products. Prof. Sambri said, Emilia-Romagna, an administrative region where he lives, purchased SARS-CoV-2 Detection Kits from Shanghai Kehua.
According to Economia e Fnanza, Italia, TGS has also provided a software application for plotting a map of high-risk areas based on the location statistics of the infected patients. The software application is available only to governmental departments and authorized companies, and patients' privacy is protected. At present, this solution has been submitted to MIUR (Ministero dell'Istruzione, dell'Università e della Ricerca), which will sign an agreement with Associazione Nazionale Comuni Italiani (Anci) for allowing municipal administration to use the solution. Some regions have already been using the software application by themselves.
On March 17, KHB had been granted EU Free Sales Certificates (FSC) for its SARS-CoV-2 Nucleic Acid Test Kit (PCR), SARS-CoV-2 IgM/IgG Antibody Test Kit(ELISA), SARS-CoV-2 IgM/IgG Antibody Test Kit(Colloidal Gold) concurrently.
On the evening of April 25, Ministry of Commerce, General Administration of Customs, and State Administration for Market Regulation of the People's Republic of China had jointly issued the Announcement on Further Strengthening the Export Quality Supervision of Epidemic Prevention Materials. It is stipulated in the announcement that China will further rectify the order of medical materials export. From April 26 onwards, enterprises that export products that are required to get certification or registration to applicable foreign standards, including SARS-CoV-2 test kits, medical masks, medical protection suit, ventilators, and IR thermometers, have to submit an electronic or a written statement, pledging that the products are up to the quality specifications and safety requirements set by the import country/region. Customs clearance will be given only to products manufactured by companies on the list of manufacturers that have passed certification or registration to applicable foreign standards. KHB SARS-CoV-2 test kits are on the approval list issued on April 26.
It is believed that KHB will, by virtue of its all-round competence and solid foundation in the development of molecular diagnostic and immunologic test methods and the manufacturing of products, supply SARS-CoV-2 test kits that contribute to the fighting against the SARS-CoV-2 epidemic worldwide.