Fujirebio Obtains Approval for Hepatitis B Rapid Test Kit in The Gambia
Fujirebio has obtained approval for the Hepatitis B rapid test kit 'ESPLINE HBeAg-hs' in The Gambia. This effort is part of a Ministry of Health, Labour and Welfare (MHLW) project aimed at establishing a system to prevent mother-to-child transmission.
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- 📰 Published: May 26, 2026 at 00:36
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Fujirebio Inc. (hereinafter 'Fujirebio'), a subsidiary of Fujirebio Holdings, Inc. (President and Representative Director: Tadashi Ninomiya; Head Office: Minato-ku, Tokyo), has announced the approval of its product registration for the Hepatitis B rapid test kit 'ESPLINE HBeAg-hs' (hereinafter 'the product') in The Gambia.
This product is a POCT*1 diagnostic agent that provides rapid and high-sensitivity detection of Hepatitis B e-antigen (HBeAg), a protein produced during the replication of the Hepatitis B virus (HBV), and is used to determine treatment strategies. The product has also obtained certification*3 based on the European In Vitro Diagnostic Medical Devices Regulation (IVDR)*2.
According to the World Health Organization (WHO), the number of people chronically infected with HBV exceeded 250 million in 2022, with an estimated 12 million new infections annually*4. In The Gambia, HBV infection is reportedly widespread*5, and the country is actively working on the prevention, diagnosis, and treatment of Hepatitis B with support from the WHO and other organizations. In this context, Fujirebio, as part of the MHLW's project for international expansion of medical technology*6, has been working with the Gambian Ministry of Health and others to build a healthcare system for preventing mother-to-child transmission of Hepatitis B, leading to this product registration.
The Fujirebio Group will continue to accelerate its contributions to global health and further address issues such as improving healthcare access.
*1 Short for Point of Care Testing.
*2 Regulation (EU) 2017/746, which applies when selling in vitro diagnostic medical devices in the EU market. Applicable since May 2022.
*3 Required for selling products in the EU; this certification allows the display of the CE mark compliant with IVDR.
*4 WHO: Hepatitis B
*5 M. Camara et al; Prevalence of hepatitis B infection in the Gambian population: A narrative review of recent developments; Preventive Medicine Reports 36 (2023) 102401
*6 Fiscal Year 2025 project for the international expansion of medical technology, commissioned by the Ministry of Health, Labour and Welfare and implemented by the National Institute of Health Crisis Management.
This product is a POCT*1 diagnostic agent that provides rapid and high-sensitivity detection of Hepatitis B e-antigen (HBeAg), a protein produced during the replication of the Hepatitis B virus (HBV), and is used to determine treatment strategies. The product has also obtained certification*3 based on the European In Vitro Diagnostic Medical Devices Regulation (IVDR)*2.
According to the World Health Organization (WHO), the number of people chronically infected with HBV exceeded 250 million in 2022, with an estimated 12 million new infections annually*4. In The Gambia, HBV infection is reportedly widespread*5, and the country is actively working on the prevention, diagnosis, and treatment of Hepatitis B with support from the WHO and other organizations. In this context, Fujirebio, as part of the MHLW's project for international expansion of medical technology*6, has been working with the Gambian Ministry of Health and others to build a healthcare system for preventing mother-to-child transmission of Hepatitis B, leading to this product registration.
The Fujirebio Group will continue to accelerate its contributions to global health and further address issues such as improving healthcare access.
*1 Short for Point of Care Testing.
*2 Regulation (EU) 2017/746, which applies when selling in vitro diagnostic medical devices in the EU market. Applicable since May 2022.
*3 Required for selling products in the EU; this certification allows the display of the CE mark compliant with IVDR.
*4 WHO: Hepatitis B
*5 M. Camara et al; Prevalence of hepatitis B infection in the Gambian population: A narrative review of recent developments; Preventive Medicine Reports 36 (2023) 102401
*6 Fiscal Year 2025 project for the international expansion of medical technology, commissioned by the Ministry of Health, Labour and Welfare and implemented by the National Institute of Health Crisis Management.
FAQ
富士レビオがガンビア共和国で承認を取得した製品は何ですか？
B型肝炎ウイルスに対する迅速検査キット「ESPLINE HBeAg-hs」です。
「ESPLINE HBeAg-hs」はどのような検査薬ですか？
B型肝炎ウイルス（HBV）が増殖する際に作られるタンパク質であるB型肝炎e抗原（HBeAg）を、簡便な操作で迅速かつ高感度に検出するPOCT（簡易迅速検査）検査薬です。
この製品はどのような場面で使用されますか？
主にB型肝炎の治療方針を決定する際に使用されます。
富士レビオがガンビアでの取り組みを行う背景は何ですか？
厚生労働省の「医療技術等国際展開推進事業」の一環として、ガンビア保健省等と協力し、B型肝炎の母子感染予防のための医療体制構築を目指しています。
本製品は他国でも規制適合していますか？
はい、欧州の体外診断用医療機器規則（IVDR）に基づく認証を取得しており、CEマークが表示可能です。