About ANDI CoE For Malaria Diagnosis

Background

The ANDI Centre of Excellence for Malaria diagnosis is a research platform in the College of Medicine, University of Lagos, Idi-Araba, Lagos, that was conceptualized to provide leadership in malaria research using the power of diagnostics that could be depoloyed in research, diseases surveillance, case mamangemt, drugs, vaccine and diagnostic trials in the area of malaria. ANDI as an acronym is African Network for drugs and Diagnostic Initiative – a directorate arm of the World Health Organization (WHO). Our research activities initially encapsulated a broad area of tropical and neglected diseases that included onchocerciasis, lymphatic filariasis, schistosomiasis, opportunistic parasitic diseases etc.
Our activities in capacity building in malaria which started after a WHO/TDR selection as an in-county malaria collection site in 2005 for the calibration and characterization of Plasmodium falciparum as a first step in the productionof quality control panels in collaboration with other institutions for global use in ensuring the quality of malaria tests.
The International Malaria Microscopy Training and RDT Quality Assurance Centre/ANDI Cantre of Excellence for Malaria Diagnosis

The International Malaria Diagnosis Centre has over the years, with funding from WHO/TDR provided the platform for Quality Assurance for Malaria Rapid diagnosis tests (RDTs). Similar Centres are located in Senegal, Ethiopia, Tanzania, Democratic Republic of Congo and Kenya. The Centre has in the process developed skills and a curriculum on malaria microscopy. Over 600 Microscopists have been trained on Malaria diagnosis with microscopy in the last 12 months. The curriculum on malaria microscopy and malaria RDTs now provides a National plat form for malaria clinical trials, especially, the drug therapeutic efficacy testing (DTET) that has important parasitologic indicators as end-points; building capacity for Microscopists in malaria sentinel sites, Training of Trainers (TOTs) etc. Indeed, the implementation of the parasite-based confirmation of malaria fever, as a policy is dependent on the attainment of high competency levels of malaria microscopists. The huge gap in capacity development, in terms of  low capacity of malaria Microscopists  in Nigeria is being addressed by a well tailored re-orientation programme in our facility. In-country malaria microscopy accreditioation is currently being done in our Centre. We have very close working collaboration with the National Malaria Control Programme and other Malaria Programme Implementers such as The Sociiety for Family Health, DFID/Malaria Consortium/SunMAP, USAID etc. We provide the platform for Malaria Microscopy Quality Assurance, Malaria RDT Quality Assurance through lot testing with time etc. The Malaria Microscopy Centre has been supported by other partners such as The CDC, Atlanta, Georgia, USA; Australian Malaria Institute etc through the WHO/TDR Networks. Other malaria diagnosis plat forms such as ELISA and PCR are already being developed especially ELISA.  This Centre has the capacity as it is to provide valuable research, development and training in the entire West African sub region. Currently, saliva and urine with detectable Plasmodiun antigens are stored in our malaria specimen bank for future characteriazation and optimization for the development of a non-invasive malaria tests. our involvement in malaria policy activities have provided very useful  guidance. Our activities is driven from the laboratory to the field where we also involved in the implementation of the parasite-based confirmation policy using malaria RDTs or microscopy. Other testing platforms are also been followed in conjunction with our collaborators.

Experience in Training Programmes at National/International Levels
The International Malaria Microscopy Training Centre, College of Medicine, University of Lagos.

Our Profile

The Tropical Diseases Laboratory of the Department of Medical Microbiology and Parasitology, College of Medicine of the University of Lagos, Idi-Araba, Lagos hosts the WHO/TDR/FIND Collaborating Center for Malaria Rapid Diagnostics Quality Assurance. We work with other partners such as the CDC, Atlanta, USA; Hospital for Tropical Diseases (HTD), UK; and The Army Malaria Institute (AMI), Australia. With the support of our partners, we have in our Malaria Specimen Bank, highly characterized panels for the provision of Quality Assurance for malaria diagnostics. We have a quality assured programme that is assessed externally every TWO years. Currently, our facility is among the WHO/TDR network for Malaria RDT Quality Assurance. Microscopy, the main comparator, forms the bed-rock of our expertise that is deployed in drug/vaccine trials, malaria base-line data acquisition for monitoring & evaluation purposes.
Our Chief Scientists’ have received international certification that rates them as National Experts using the recent WHO Malaria Microscopy guideline. Since then, we have certified a number of Microscopists using the recommended guidelines. A malaria microscopy curriculum for various cadre of Health Worker is in place and is currently being considered for University approval as a separate programme. In addition, we have commenced the process of certification by the Standard Organization of Nigeria for quality. Our operation generally is done in accordance to the dictates and dictum of Good Clinical Laboratory Practices (GCLP). We follow very stringent procedures that have produced the expected deliverables for the targeted groups and Agencies.

Our Services:

  • Quality Assurance for Malaria Rapid Diagnostic Tests (MRDTs). We provide the following services:
    • Pre-procurement testing of RDT samples to ensure that are suitable for use in hospitals. They must pass quality control before being deployed for use.
    • Lot testing.
    • Post deployment quality assurance for consistency of performance.
    • Training on MRDTs (training manuals being developed), supervision and monitoring.
  • Malaria Microscopy Quality Assurance Programme: This has become imperative for an effective case management of malaria because of limitations in malaria microscopy skills, over diagnosis of malaria based on clinical symptoms alone, best practices and quality care for patients. Health workers involved in malaria diagnosis are supervised monthly and challenges addressed promptly. GCLP that could be extended to other diagnostic conditions will be entrenched and sustained in a timely fashion thus creating the highly desired work ethics with success in patient’s management being the bottom line.
  • Malaria Microscopy Training and Certification Programme (2006 – Date). We have an internationally recognized INTERNATIONAL MALARIA MICROSCOPY TRAINING CENTER with our curriculum designed to undertake 5 – 7, 10 days, 2 weeks – 4 weeks training programme and refresher course for various categories of health worker.  This guarantees accurate and reliable malaria diagnosis for better patient management and the production of reliable base-line data for assessing the impact of any intervention. Health workers in the private and public sectors are trained to acquire skills in detecting malaria even in lower densities, quantifying malaria parasitaemia , species identification, internal quality control mechanisms and provided with Standard Operating procedures (SOPs) templates , Microscope maintenance skills, etc to enable them perform optimally. Strictly speaking, this training arm is part of our malaria diagnosis quality assurance programme.

This Centre is involved in the provision of National Quality Assurance services for malaria rapid diagnostic tests and malaria microscopy; and the training of Malaria Microscopists from several zones of the country.

Training organized nationally:

  • Malaria Microscopy Course for Laboratory Scientists (2006): 12 participants
  • Malaria Microscopy Workshop (2007): 12 participants
  • Malaria Microscopy Workshop (2008): 12 participants
  • Malaria Microscopy Workshop for APIN staff (January 2009): 12 participants
  • Malaria Microscopy competency Assessment and Quality Assurance Training (DFID/SuNMAP, June 2009) – Two sessions in different States of Nigeria: 8 participants at each site
  • Malaria Microscopy Certificate Course for Microscopists from 14 sentinel Sites of Nigeria for The Malaria drug therapeutic efficacy testing in collaboration with the National Malaria Control Programme (August/September, 2009) : 14 participants
  • Global Fund/Society for Family Health/Federal Ministry of Health’s Malaria Microscopy Training Course (2010): 411 Microscopists trained.
  • Malaria Microscopy Course for Exxon Mobil Microscopists in Lagos Area : 21 participants (2010)
  • Malaria Microscopy Course for Exon Mobil Microscopists in Eket/Uyo area – held in Uyo Akwa Ibon State: 21 participants ( May 2011).
  • Malaria Microscopy Course for Private Laboratory Scientists (November 2011)
  • Malaria Microscopy Training for MAPs, supported by the Centre for Microscopists from Zamfara, Cross River, Oyo, Nasarawa and Ebonyi State: Over 200 Microscopists trained (April – June, 2012).
  • Specialized malaria Microscopy for Staff of the Liquified natural Gas (LNG) Laboratory: (July, 2012).
  • Quality Assurance on Malaria Microsocpy – Proficiency testing for 26 laboratory Staff drawn from 13 facilities in North and south Nigeria (on going).
  • Malaria Microscopy Capacity building for Malaria Microscopists for Quality Assurance in ten States of Nigeria: Malaria Consortium, Nigeria: 2012 – 2013.

Coordinated the training of over 5,000 healthcare providers on the use of RDTs in malaria case management in seven States of Nigeria.External Quality Assurance (EQA). Proficiency testing and site visitation is undertaken regularly to ensure that skills and best practices are maintained. Currently, we have a good number of laboratories enrolled in our EQA programme and are benefiting from our expertise. Apart from being recognized by other malaria EQA programmes, we have worked closely with other stakeholders in Oman and South Africa in producing high quality malaria parasite reference materials thus developing a malaria slide bank of international standard.

Malaria Microscopy Services to Organizations and the National Malaria Control Programe (NMCP) of the Federal Ministry of health.

NMCP, Federal Ministry of Health

  • National Malaria Indicator Survey in six Geopolitical zones – Over 5,000 slides generated and read (2010)
  • MABA studies – Over 6,000 slides read (2011)
  • Currently planning for the 2014 National Malaria Indicator Survey.

DFID/Malaria Consortium/SuNMaP 2009 – 2013 Activities

  • Malaria Microscopy/Quality Assurance activities with DFID/Malaria Consortium Malariometric Studies in Kano and Anambra State
  • Annual malaria microscopy capacity building for pre-study scientist (2009 – date)
  • Engaged to read over 8,000 slides for the 2010 – 2013 malaria area studies
  • Microscopy for Seasonal Malaria chemoprevention (SMC) studies piloted in katsina State (935 slides form children less than 5 years).

Lagos State Ministry of Health

  • Malariometric study in Ojo and Ikorodu Local, Lagos State – 2009
  • Malaria survey in Lagos State (January – April, 2011) – in 13 randomly selected LGs and 58 communities
  • 12,227 slides prepared from the field and read

WHO/TDR/FIND RDT in Malaria in Pregnancy Studies (2010- 2013)- Quality Assurance Service

  • Multi-center and multi-country study on the use of malaria RDTs in Pregnancy
  • To provide quality assurance on malaria microscopy for slides coming from Uganda & Burkina Faso
  • Uganda study: approx 97% concordance with pcr
  • Burkina Faso – slide read with >97% concordance with pcr

Regional Malaria Slide Bank with the World Health Organization (WHO)
Submitting protocol and materials to WHO for designation as a regional Centre for Malaria slide bank resources. High quality malaria slides for teaching, quality assurance and certification.

Brief About the in-Country Malaria Specimen Bank Site –

Collection of Wild Type Plasmodium and Calibration for QC Specimen for Global Product and Lot Testing.
The in-country’s malaria specimen collection site was established in 2006 after a competitive call by WHO/TDR to set up African collection sites in addition to the collection sites that existed in Philippines and Cambodia. Four sites in Africa were selected initially in Africa. These were: Nigeria, Tanzania, Central African Republic and Kenya; two other sites, namely, Senegal and Ethiopia were added to the network later on.

Over the years, Nigeria has contributed QC samples obtained from clinical specimens to the Global Specimen Bank from where the annual RDT Product evaluation is done. A new batch of 60 QC from clinical samples has just been collected and calibrated. All collected samples are fully characterized (by several members of the network) before they are used as quality control panels for initial and lot testing of malaria rapid diagnostic tests (see methods employed below). The in-country malaria specimen bank site is however self-sustained through charges for quality assurance testing. A sub-set of QC Samples maintained at the in-country collection site are shared with the Global Specimen Bank. Initial results on 28 samples on which pcr was conducted by the Centre for Disease Control (CDC), Atlanta, Georgia, USA showed that all species calibrated where mono species of Plasmodium falciparum.

The ANDI Centre of the University of Lagos has consistently produced QC samples for the third year running because of the available high competency in malaria microscopy (See WHO, Geneva, Switzerland ethical approval for the activity).

Biobank for Malaria and Fever Pathogens

A huge bank of parasite serum and parasite products in blood spot is being developed. Currently, this bio bank is being expanded for antibody profiling, proteomics, metabolomics, etc for parasite targets assessment for diagnostic markers among others.

ANDI Centre of Excellence

Our facility is one of the 32 designated Centres of excellence by WHO/ANDI  in 2011. See Press Release – ANDI establishes 32 Centres of Excellence in Health Innovation in Africa:

NOTE: The ANDI Centre of Excellence for Malaria Diagnosis, University of Lagos has just been selected as one of the Centres for the WHO/TDR Demonstration Projects in the evaluation of candidates diagnostic products and capacity building. Updates on this selection would be made available shortly.

Facilities for Malaria Microscopy Training:

  • 3 Rooms for Microcopy reading
  • 1 Preparatory room – slide staining, drying
  • Open Laboratory – 60 – 80 capacity setting.
  • RDT Quality Assurance room
  • 68 Binocular microscopes
  • Slide preparation templates
  • Micropipettes and tips
  • Malaria microscopy manuals and bench aids
  • High quality slide sets – prepared locally.
  • High quality Giemsa Stains.

External Quality Assurance Capacity

Participated in EQA activities with the Ministry of Health, Oman, and the Non-communicable Diseases Laboratory, South Africa.

WHO Certified Microscopists

  • Three of our Malaria microscopists certified by WHO and University of Lagos has three of the four certified in the Country.
  • Four other microscopists are being prepared for certification.

Preparation and Supply of Microscopy Products/Materials

  • High quality Giemsa Stains – Supplied for the DTET studies in 2009/2010; Malaria Area surveys of SunMaP, 2009 – 2011; hospitals and laboratories and research centers in the country. Currently, we have just been awarded the order to prepare and supply high quality Giemsa stains. This is a great contribution from the University of Lagos in providing products. More information on this process would be available to be shared very soon and we are happy with the privilege.
  • Highly characterized quality control malaria slides for teaching and certification. Quality slides have been supplied to Swaziland to support their malaria control activities.