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NAFDAC registers seven rapid diagnostic products for HIV, hepatitis, others

Director General, NAFDAC, Prof. Mojisola Christianah Adeyeye

The National Agency for Food and Drug Administration and Control (NAFDAC) has registered seven rapid diagnostic product families, expanding the range of locally developed testing options available in Nigeria.

The registrations cover 12 Stock Keeping Units (SKUs) across four key areas of healthcare testing — HIV, malaria, hepatitis and pregnancy.

The products, developed by Nigerian diagnostics company Ash Biomedical Diagnostics Ltd., include ABD HIVChek, MalChek, MalChek Plus, HepaQuik, HepaQuik Duo, PregSure and FlaviQuik.

Among the latest additions are FlaviQuik, a rapid test for Hepatitis C, and HepaQuik Duo, which provides dual screening for Hepatitis B and Hepatitis C using a single test.

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The development provides healthcare providers and screening programmes with additional rapid-testing options for identifying patients who may require further medical evaluation.

NAFDAC registration provides the regulatory basis for the marketing of the products in Nigeria, while continued quality assurance, field performance and post-market monitoring remain important to sustaining confidence in diagnostic products.

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The development also comes amid efforts to strengthen local healthcare manufacturing and expand access to diagnostic services across the country.

According to the company, its products have reached all 36 states of the federation, with 15 million test kits supplied over the past 15 years through more than 66 government and institutional contracts across 27 states.

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The company also said independent evaluations conducted by the APIN Reference Laboratory, NISA Premier, Garki Hospital, Police Clinics and the National Hospital, Abuja, recorded 100 per cent concordance between its rapid-test results and reference laboratory findings in evaluated samples involving HIV, hepatitis B, pregnancy and malaria testing.

Chief Executive Officer and Managing Director of Ash Biomedical Diagnostics Ltd., Adetoyese Shodeinde, said the registrations reflected years of investment in product development, quality assurance and regulatory compliance.

“Our vision has always been bigger than producing diagnostic kits,

“We are building confidence in Nigerian healthcare manufacturing by ensuring that every product carrying the Ash Biomedical name meets the standards required for quality, reliability and national regulatory approval”, she said.

Shodeinde said the milestone demonstrated that Nigerian companies could develop diagnostic products capable of meeting the requirements of healthcare professionals and patients.

The company is also developing a diagnostics manufacturing facility in Idu, Abuja, which it said is in the final phase of construction and equipment installation.

The facility, according to the company, is expected to be commissioned in the first quarter of 2027 and is intended to increase local production capacity and reduce dependence on imported rapid diagnostic products.

The company said the planned facility, alongside its expanding product portfolio, forms part of efforts to strengthen Nigeria’s healthcare manufacturing capacity and support wider access to rapid diagnostic testing.

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