Healthcare localization and standardization support the Belt and Road Initiative
In Addis Ababa, a brand-new in vitro diagnostics (IVD) test kit factory – the first in Ethiopia to obtain ISO13485 related to medical device quality management standards – seeks to enhance Africa's healthcare accessibility and availability. BGI Health Ethiopia, a subsidiary of BGI Genomics Co., Ltd, operates this factory.
BGI Health Ethiopia team is undertaking data analysis
In line with the Belt and Road initiative (BRI) to enhance global health outcomes, this IVD test kit factory, a pioneer in Africa, produced the continent's first RT-PCR and rapid antigen test kits during the COVID-19 pandemic. Now, this factory is establishing additional production lines at a new location to manufacture test kits for various diseases. BGI Health Ethiopia has prepared the documentation and is awaiting GMP (Good Manufacturing Practice) inspection.
Rodas Ayichew, Production Manager, plays a pivotal role in the production of IVD tests that are changing the face of healthcare in Ethiopia and beyond. He recalls: "BGI Genomics leads research worldwide and has a great track record in introducing new technologies focused on improving health outcomes. This meaningful aspect to Ethiopia and Africa was my main reason to join the company in 2022."
Hepatitis C virus infection is known as a silent killer because patients often experience no apparent symptoms until the infection causes serious health complications. Rodas notes that hepatitis C infection is a significant public health issue in Ethiopia, with certain regions having a higher prevalence of up to 22%.
This virus is a genetically heterogeneous bloodborne pathogen, with 75–85% of patients progressing to chronic hepatitis. Globally, the WHO estimates 58 million people have chronic hepatitis C virus infection, with about 1.5 million new infections occurring per year.
"We trained over 20 personnel for IVD manufacturing and are among the first in Ethiopia to obtain hepatitis C virus, HCG (pregnancy urine tests), Treponema palladium (syphilis tests) and typhoid rapid diagnostic tests (RDTs) kits certification from the Ethiopian Food and Drug Authority. By making the hepatitis C test more accessible and available, this will reduce the cases of chronic hepatitis and liver cirrhosis," says Rodas.
Moving to a new location comes with challenges. Still, Rodas expresses confidence in his ISO13485-certified team, which has demonstrated problem-solving skills and dedication to master the latest technology, production techniques, and quality control.
Rodas comments, "From my perspective as a production manager, there is potential to do so much more, not only in Ethiopia but to export to other African countries. We conducted a market survey covering around 20 IVD tests before deciding on seven tests in our updated production line. All these tests involve diseases with high prevalence in Ethiopia and Africa. With enhanced production and quality, I am also keen to take more responsibility and look forward to contributing to public health in Ethiopia and all across Africa."
