OraQuick HIV-test kits

Healthcare workers have welcomed the launch of Uganda’s first local manufacturing facility for ‘OraQuick’ HIV self-test kits, saying it will significantly increase the number of people who know their HIV status and help the country meet its goal of ending the AIDS epidemic by 2030.

The factory, owned by Zakayo Industries Limited and located in Ntenjeru, Mukono district, was commissioned on Thursday. It produces the oral fluid-based self-test kits in partnership with US-based OraSure Technologies. The commissioning also saw the dispatch of the factories first export of self-testing kits to Kenya.

Shamim Naggayi, plant manager, said the introduction and now local production of the kits has encouraged more Ugandans to test themselves. Many previously avoided testing because of fear of visiting hospitals and the limited number of facilities offering the service.

“When it was introduced on the market in 2018, the product cost about Shs 40,000. At the moment, you will find it at Shs 25,000 to Shs 30,000 in pharmacies,” Naggayi said. “Our target as Zakayo Industries is to bring the cost of this product to as low as Shs 7,000, so every Ugandan can afford it.”

She noted that the kits are already distributed free through government public health facilities. Lowering the retail price will improve access for those who prefer to buy them privately. The plant currently produces between 50,000 and 60,000 kits per day, up from about 10,000 per eight-hour shift when assembly began in June.

It employs more than 120 workers and plans to move from assembly and secondary packaging to full manufacturing of diagnostic devices by 2028.

Ronald Wantanda Zakayo, chief executive officer of Zakayo Industries, said the company is built on three pillars: reducing the spread of HIV, creating jobs, and generating tax revenue for the country.

“Twenty-five years ago, we imported everything. Tomorrow, we should be exporting. As a matter of fact, we exported today,” he said, referring to the company’s first consignment of locally made products sent to Kenya.

He said that while 94 out of 100 people know their status in some assessments, a significant gap remains, with estimates indicating tens of thousands of Ugandans still unaware of their HIV status — a dangerous situation that self-testing can help close.

Michael Cleverly, US Chief of Mission, said the partnership between the United States and Uganda in the health sector has spanned 90 years and has transformed the country’s health system, extending also into research and education.

“As long as I remain US Chief of Mission, I will continue to encourage foreign companies to invest in the country in order to improve people’s lives in the economy, education, and health sectors,” he said.

Dr Charles Olaro, Director General of Health Services at the ministry of Health, thanked the Government of Uganda for supporting the factory. He said local production will reduce reliance on imported testing materials and the foreign exchange previously spent on them.

Self-testing, he added, enables people to discover their status early so they can seek treatment while the infection is still in its early stages. Citing the Uganda Population-based HIV Impact Assessment survey that put national HIV prevalence at 5.9 per cent, Dr Olaro estimated that between 150,000 and 200,000 Ugandans still do not know their status. Self-testing is particularly useful for reaching men and young people who face barriers to conventional testing services.

OraQuick allows users to screen themselves using an oral fluid sample without drawing blood or needing a health worker. A reactive result is not a confirmed diagnosis and must be followed by confirmatory testing and linkage to care.

John Ballester, OraSure Technologies’ senior director for international diagnostics, said the partnership reduces logistical challenges of shipping products across continents. Raw materials were previously made in the United States, assembled in Thailand, and then transported to African markets. Geopolitical tensions, rising freight costs and supply-chain disruptions have made local manufacturing more important.

The company plans to expand production with Zakayo Industries to other diagnostics, including Ebola tests, and later explore hepatitis and sickle cell disease tests. The Mukono facility has obtained ISO 9001 and ISO 13485 certifications.

Health officials say the combination of local production, lower prices and greater privacy will accelerate progress toward the 2030 target of ending AIDS as a public health threat in Uganda.

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