Issues: Quality-management systems (QMS) are uncommon in clinical laboratories in Nigeria, and until recently, none of the nation's 5 349 clinical laboratories have been able to attain the ...certifications necessary to begin the process of attaining international accreditation. Nigeria's Human Virology Laboratory (HVL), however, began implementation of a QMS in 2006, and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008), making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO) accreditation preparedness scheme. Theexperience of the QMS implementation process and the lessons learned therein are shared here. Description: In 2005, two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar, Senegal. Following this peer-to-peer technical assistance, several training sessions were undertaken by HVL staff, a baseline assessment was conducted, and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009) are presented herein. Lessons learned: Although there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process, the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated). Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation, however, could provide the renewed vigour needed to correct these non-conformities. Recommendation: This experience shows that sustainability of the QMS at present is a cause for concern. However, the tiered system of accreditation being developed by WHO-Afro may act as a driving force to preserve the spirit of continual improvement.
This study investigated the diversity of rotavirus strains recovered from young children in Lagos, Nigeria, during December 1996-January 1997. In total, 287 children, aged 1-60 month(s), presenting ...with diarrhoea to the Gbaja Health Centre of Massey Street Children Hospital and the Lagos University Teaching Hospital, were included in the study. Rotavirus-positive specimens were characterized by monoclonal antibody enzyme-linked immunosorbent assay (ELISA) for VP6 subgroup and VP7 serotype and by polymerase chain reaction (PCR) for VP4 genotype and VP7 strains (that were non-reactive to ELISA). Of 84 samples tested for VP6 subgroup epitope, subgroup II was predominant (51%) with only a few subgroup I strains (4%), while many could not be typed at all (45%). For the VP7 serotypes, G1 was the most prevalent strain (45%), followed by G3 strains (5%). Neither G2 nor G4 strains were found, although mixed G1/G2 has been reported for the first time in Nigeria. Of strains that were non-reactive to ELISA, 29 (34%) could not be typed by PCR for G type. A subset of 23 samples was selected on the basis of RNA electropherotype, VP7 serotype, and included nine strains of VP7 that were non-reactive to ELISA. VP4 genotype of this subset was determined by PCR, and the most prevalent genotype was P6 (30%), followed by P8 (26%). Only one P4 strain was identified. This study has shown the diversity of rotavirus strains circulating in West Africa.
Background: The Nigerian Institute of Medical Research houses two reference laboratories: the virology and tuberculosis laboratories. Both were enrolled in the Strengthening Laboratory Management ...Toward Accreditation (SLMTA) programme. Objective: To describe the impact of SLMTA and discuss factors affecting the results, with an emphasis on mentorship. Methods: The SLMTA programme was implemented from April 2010 through November 2012. Participants attended three workshops and executed quality improvement projects; laboratory auditors evaluated performance using a standard checklist. The virology laboratory did not receive mentorship; however, the tuberculosis laboratory had an international mentor who visited the laboratory four times during the programme, spending two to four weeks embedded within the laboratory during each visit. Results: There was an overall improvement in the performance of both laboratories, with the virology laboratory increasing 13% (from 80% at baseline to 93% at exit audit) and the tuberculosis laboratory increasing 29% (from 66% to 95%). These scores were maintained nine months later at the surveillance audit. Conclusion: The SLMTA programme resulted in improved and sustained quality management performance for both laboratories. Mentoring was a possible factor in the substantial improvement made by the tuberculosis laboratory and should be considered in order to augment the training received from the SLMTA workshops.
Background: Proficiency testing (PT) is a means of verifying the reliability of laboratory results, but such programmes are not readily available to laboratories in developing countries. This project ...provided PT to laboratories in Nigeria. Objectives: To assess the proficiency of laboratories in the diagnosis of HIV, tuberculosis and malaria. Methods: This was a prospective study carried out between 2009 and 2011. A structured questionnaire was administered to 106 randomly-selected laboratories. Forty-four indicated their interest in participation and were enrolled. Four rounds of pre-characterised plasma panels for HIV, sputum films for tuberculosis and blood films for malaria were distributed quarterly by courier over the course of one year. The results were returned within two weeks and scores of ≥ 80% were reported as satisfactory. Mentoring was offered after the first and second PT rounds. Results: Average HIV PT scores increased from 74% to 95% from the first round to the third round, but decreased in the fourth round. For diagnosis of tuberculosis, average scores increased from 42% in the first round to 78% in the second round; but a decrease to 34% was observed in the fourth round. Malaria PT performance was 2% at first, but average scores increased between the second and fourth rounds, culminating in a fourth-round score of 39%. Many participants requested training and mentoring. Conclusions: There were gross deficiencies in the quality of laboratory services rendered across Nigeria. In-country PT programmes, implemented in conjunction with mentoring, will improve coverage and diagnosis of HIV, tuberculosis and malaria.
In order to establish the role of adenovirus in gastroenteritis in Nigerian children, stool samples were collected from 138 young children with gastroenteritis and 29 other age-matched controls. The ...samples were inoculated into 6 different tissue culture cell lines and isolates with characteristic CPE were subjected to CFT confirmation of the presence of adenovirus antigen. All the samples were screened for adenovirus by a commercially available enzyme immunoassay (Biotrin Adenovirus Antigen EIA) for the presence of the group antigen. Of the 138 stool samples from children with diarrhoea screened by EIA, only 23 (16.7%) were positive, while 4 (13.8%) of the 29 controls were also found positive. A greater proportion of the adenovirus-positive cases were aged between 13 and 24 months. There was no difference in the prevalence of the infection between male and female. The fastidious, enteric adenoviruses of subgroup F were sought utilizing a second EIA (AdenoClone), and occurred in 3.6% of the samples from diarrhoeic children and was not detected in the control group. There was no significant difference between the clinical symptoms of children infected with adenovirus and those not infected with adenovirus. However, the source of drinking water had a significant effect on the frequency of stool per day. The infection occurred all year round except for April and there was no significant correlation with the climatic factors. This study implies that the fastidious adenovirus is important in the aetiology of diarrhoeal illness in Nigerian children.
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