Nigeria gets WHO-prequalification for lab test kits

*NIMR joins list of ten centres that can conduct independent performance evaluations of IVDs used in diagnosis, monitoring of HIV, hepatitis infections

The Nigerian Institute of Medical Research (NIMR) has been listed as a World Health Organisation (WHO) prequalified evaluating laboratory to perform assessment of In Vitro Diagnostics (IVDs) commissioned by manufacturers.

This means that Nigeria is now part of the ten laboratories currently enlisted as WHO prequalification laboratories all over the world. They are located in eight countries of the world namely: Australia, Belgium, France, India, Nigeria, South Africa (two), Tanzania and United Kingdom (two).IVDs are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

Stakeholders say this no mean feat being the first in West Africa and would boost the nation’s healthcare and reduce overseas medical tourism.The implication is that NIMR’s Centre for Human Virology and Genomics (CHVG) would now conduct independent performance evaluations of IVDs, which will assist in the diagnosis and/or monitoring of infection with Human Immuno-deficiency Virus (HIV)-1/2, hepatitis B and hepatitis C.

According to stakeholders, another implication of this WHO prequalification is that results from the laboratory are of international standards and can be compared with other laboratories across the world.Director General of the institute, Prof. Babatunde Salako, said that the use of tested IVDs would ensure early and accurate diagnosis of diseases, drastically reduce morbidity and improve the nation’s healthcare.

Salako, during a press briefing on the WHO listing of NIMR’s CHVG as a prequalification evaluating laboratory said that IVDs can now be evaluated when coordinated by WHO or commissioned by the manufacturers.Describing the achievement as an effort of the institute’s committed leaders and staff, he said ability to carry out the test would assist in determining the validity of medical kits brought to the country.

Salako said that prior the WHO accreditation, there was no institute in West Africa to effectively do the test; hence companies rely on Western certification of kits, which may not tally with what is obtainable in Nigeria.

“NIMR’s CHVG has developed the proficiency to test if the kits are as good as the function it performs. This would reduce false diagnosis and stigma of the HIV1 and 2, syphilis, hepatitis B, hepatitis C, Human Papilloma Virus (HPV) and Glucose-6-Phosphate Dehydrogenase (G6PD),” he noted. On how the accreditation was achieved, the DG said it was because of the sound laboratory back up that management of the institute has developed over the years.

In his words: “You will recall that we briefed you late last year when our laboratory at the CHVG in the microbiology department obtained ISO 15189:2012 accreditations from the South African National Accreditation Scheme for practicing quality management system.“We were at the time the first public laboratory in Nigeria to be so accredited. The implication of that is that our results in the area accredited are of the same standard with results from similar laboratories all over the world.

“Today, the same laboratory has just been listed as a WHO Prequalification Evaluating Laboratory, being the first in West Africa. This happened after a successful re-audit of the laboratory to ISO 15189:2012 standard by WHO Geneva on Monday 22nd January 2018.”

According to reports, the accreditation was given after WHO invited national laboratories with experience in conducting independent performance evaluations to submit an Expression of Interest for prequalification evaluating laboratories.The laboratories were required to have experience in performance evaluations of IVDs used for diagnosis and/or monitoring of infection with HIV1 and 2, syphilis, hepatitis B, hepatitis C, Human Papillomavirus (HPV) and Glucose-6-Phosphate Dehydrogenase (G6PD).Salako noted that the performance evaluation was done to ensure acceptable presentation of test kits before product registration in the country and/or before they are recommended for mass screening exercise.

On the laboratory routine diagnostic services, he said that the CHVG check for HIV-1 confirmation, HIV-1 viral load and early infant diagnosis to the institutional HIV treatment center, which cares for over 20,000 patients and patients from other health facilities.“The center also conducts Hepatitis B and C serology and viral loads for several other hospitals and laboratories across the country. We have in our bio-repository a pool of characterised panels for HIV, hepatitis B and C prepared for this purpose, with skilled and competent personnel for this purpose,” he added.

Salako said that NIMR would continue to improve the quality of the laboratory services for highly impacting research of national relevance that would trigger national development.“With improved funding, we will do something significant in terms of disease prevention and management. The research group is working on getting a vaccine for Lassa fever and monkey pox already,” he added.

Deputy Director Research and Laboratory Director CHVG, Dr. Rosemary Audu, said the qualification would allow for an inclusive care in Nigeria and reduce medical tourism.
She said hepatitis B and C kits usually give different result if not properly tested before used on the field.

This, Rosemary said has affected the statistic of people with this diseases and had prevented proper planning in terms of providing drugs needed.“We evaluate the rapid test kits used at the point of care to know if it meets the standards, this we do not compromise,” she added. On maintenance of the machines, she said that technicians have been routinely scheduled to monitor and ensure their effectiveness.

NIMR was established to conduct research into diseases of public health importance in Nigeria and develop structures for the dissemination of research findings while providing the enabling environment and facilities for health research and training in cooperation with the federal and state ministries of health and in collaboration with universities, allied institutions and organized private sector nationally and internationally.