The Biomedical Research and Training Institute Laboratory is a key department that provides relevant laboratory investigations for all projects conducted at the Institute. From its inception it was recognized that the BRTI Laboratory should provide competent and ethical laboratory services primarily to research studies, and would complement rather than compete with national diagnostic services. The great of investigative tests are ones that were not routine, though over time they may have become included into more routine laboratory work. The laboratory provides facilities and supervision on on-bench training for students fulfilling various academic qualifications and designs, organizes and completes laboratory oriented developmental courses for researchers and laboratory scientists.

The relocation of the institute from the Veterinary Research building on the main UZ campus to the premises of the National Institute for Health Research (NIHR) and Parirenyatwa Hospital (PH) was completed during this time. The BRTI core laboratory which has a general medical bacteriology, parasitology, serology (including HIV testing) a cell culture laboratory and the archiving unit plus all the other BRTI laboratory activity was established at NIHR while for reasons of safety the TB laboratory was based at PH. This laboratory was primarily a project laboratory servicing the DetecTB project, and included facilities for microscopy (light and fluorescence) and culture on solid media. The laboratory has since become part of the main BRTI laboratory structure, with service being provided to other projects and services

Organisation and management

As a component of the BRTI, the laboratory operates within the policies and principles set by the Executive Management Committee (EMC) of BRTI for its daily activities, and the laboratory’s coordination, performance, input and feedback are obtained through meetings of Laboratory and Training sub-committees and representation on guiding committees for special areas such as the ISO Steering Committee and the Finance Committee. Key to the laboratory activities is the Laboratory Committee which meets once every month and comprises of all the MLSc from the three laboratory units, Principal Investigators of projects, the QMS Manager/Deputy Manager, the Finance and Office Managers, and is chaired by the Laboratory Director and in his absence the Senior Laboratory Manager usually with the Director General in attendance. A wide range of issues that affect laboratory activities - scientific, managerial, financial and social – are raised and discussed.

Ethics

As already mentioned, the BRTI Laboratory’s main purpose is to provide relevant support on laboratory investigations on all projects within the BRTI. These are the projects that would have received IRB and usually Medical Research Council of Zimbabwe (MRCZ) approval(s). As such the laboratory investigations are therefore done within the framework of the projects’ ethically approved protocols. However, recent developments have seen some studies being generated directly from the laboratory, and for these the responsible laboratory personnel seek ethical approval from BRTI IRB and /or MRCZ. In addition, the laboratory is registered with the Health Profession Authority (HPA) Zimbabwe as a Research Laboratory under the Health Professions Act Chapter 27:19 and hold a valid practicing certificate which is renewable annually on satisfying HPA conditions. The HPA regulates professional conduct of Medical Laboratory Scientists as described in the Medical Laboratory Scientist Conduct Regulations 1999, Chapter 27:08, Statutory Instrument 42. Each BRTI Laboratory unit is headed by an HPA registered MLSc in order to ensure compliance to the regulations.

Quality Management System (QMS)

The BRTI QMS is based on ISO 15189 "Medical Laboratories – Particular requirements for quality and competence”, and addresses both the "Management" as well as the "Technical" requirements. As such it has come up with the following Quality statement in its quest to contribute to the overall BRTI’s business goals.

Quality Statement

The BRTI Laboratory is a committed centre of excellence in biomedical research and diagnostic services, in compliance with the requirements of ISO 15189. It pride itself with highly qualified professionals at managerial and technical level who are dedicated to produce accurate, reproducible and timeous results through application of up to date cost effective techniques. Its drive is to empower the region by establishing and maintaining high levels of quality, efficiency, professionalism and ethical standards in its activities.

Other efforts to ensure quality output from the BRTI laboratory are the continued subscriptions to the proficiency testing with the Zimbabwe National Quality Assurance Programme (ZINQAP) for its various laboratory investigation tests which include MTB microscopy, culture and identification, general serology and HIV testing. With regards TB the laboratory also participates in external quality assessment with the National Health Laboratory Services of South Africa (NHLS).Reports are displayed within the laboratory departments

Personnel

The current total staff complement of the two laboratory departments is eighteen (18), comprising 7 at BRTI core laboratories and 11 at the DetecTB laboratories. The 18 consist of 1 Clinical Scientist and 5 Medical Laboratory Scientists (MLSc) who are registered with the Health Profession Authority (HPA) and hold practicing certificates that are renewed annually. The remaining 11 include 3 Laboratory Research Scientists with Science degrees but not registered with the HPA, 7 Laboratory technicians and 2 General hands. Table below gives the distribution of staff among the two lab components

The number of staff members at any given point is related to the personnel requirements of active projects/researches. Staff is recruited either on permanent or on contract basis. Contract members are recruited on project funding for periods ranging between 1 – 5 years, while permanent members are on the institute’s pay-role and constitute only 11% of the staff complement. However, the organization of the BRTI is such that there is a pool of supportive staff such as drivers, financial accounting officers, data entry clerks and Information Technology (IT) officers who have part of their duties as servicing the laboratory but are shared with BRTI functional units. Members of staff are encouraged to attend courses on professional development, including courses on molecular diagnostics, quality control in infectious disease laboratories and antimicrobial susceptibility testing. Staff are also encouraged to become proficient in computing (through ICDL courses), statistical techniques, defensive driving and first aid.

Laboratory courses

A course on molecular techniques in the diagnosis of enteropathogens was held, in collaboration with University of Sassari, Italy in December 2007. The course was attended by 8 national participants with one participant from Mozambique. The BRTI is a sub-recipient of the TB Component of the Global Fund Round 5 which is to be specifically executed by the laboratory. The program intends to train 180 laboratory staff in laboratory science, TB microscopy, malaria microscopy and rapid HIV testing. These trained microscopists are to be used by the Ministry of Health and Child Welfare as laboratory microscopists at district level. Because of delays in disbursement of funding, the program could not start until late 2008.

Diagnostics

Cyscope evaluation

With support from Partec, a study was carried out to compare the detection of malaria parasites in peripheral blood smears using the “Cyscope” malaria rapid fluorescent microscopic technique with light microscopy of Giemsa-stained smears. A total of 295 blood smears were collected from patients of all age groups presenting with clinical signs and symptoms of malaria to 10 City Health Clinics in Harare. For each patient two blood films were prepared. Microscopic examination was done independently in two laboratories, with one doing the Giemsa stain and the other the Cyscope method. After the tests were completed, the results were then matched and recorded without any alterations. There were an equal number of men and women who were malaria positive and age ranged from 5-66 years. Concordance in the detection of parasites (both tests positive or negative) was 98.6 % (291/295). In all four cases of discordance malaria parasites were detected using the Cyscope but not with conventional microscopy. The Cyscope gave a 100% sensitivity and a specificity of 98.6%

Other diagnostics

Only a limited number of fluorescent antibody tests for rickettsial infection were carried out. Problems in the supply of suitable antigen, and the small number of requests for this service means that the test will be phased out. The laboratory carried out a number of TB diagnostic investigations for the private sector.