Field expansion of DNA polymerase chain reaction for early infant diagnosis of HIV-1: The Ethiopian experience.

BACKGROUND: Early diagnosis of infants infected with HIV (EID) and early initiation of treatment significantly reduces the rate of disease progression and mortality. One of the challenges to identification of HIV-1-infected infants is availability and/or access to quality molecular laboratory facilities which perform molecular virologic assays suitable for accurate identification of the HIV status of infants. METHOD: We conducted a joint site assessment and designed laboratories for the expansion of DNA polymerase chain reaction (PCR) testing based on dried blood spot (DBS) for EID in six regions of Ethiopia. Training of appropriate laboratory technologists and development of required documentation including standard operating procedures (SOPs) was carried out. The impact of the expansion of EID laboratories was assessed by the number of tests performed as well as the turn-around time. RESULTS: DNA PCR for EID was introduced in 2008 in six regions. From April 2006 to April 2008, a total of 2848 infants had been tested centrally at the Ethiopian Health and Nutrition Research Institute (EHNRI) in Addis Ababa, and which was then the only laboratory with the capability to perform EID; 546 (19.2%) of the samples were positive. By November 2010, EHNRI and the six laboratories had tested an additional 16 985 HIV-exposed infants, of which 1915 (11.3%) were positive. The median turn-around time for test results was 14 days (range 14-21 days). CONCLUSION: Expansion of HIV DNA PCR testing facilities that can provide quality and reliable results is feasible in resource-limited settings. Regular supervision and monitoring for quality assurance of these laboratories is essential to maintain accuracy of testing.

Genotypes and viral load of hepatitis C virus among persons attending a voluntary counseling and testing center in Ethiopia.

The prevalence of different genotypes of hepatitis C virus (HCV) in Ethiopia is not known. HCV genotypes influence the response to therapy with alpha-interferon alone or in combination with ribavirin. A cross sectional study was conducted on attendees of voluntary counseling and testing center. Serum samples from 1,954 (734 HIV positive and 1,220 HIV negative) individuals were screened for HCV antibody. Active HCV infection was confirmed by quantitative PCR in 18 of the 71 samples with anti-HCV antibodies. The HCV viral load ranged from 39,650 to 9,878,341 IU/ml (median 1,589,631 IU/ml) with no significant difference [χ(2)(17) = 18.00, P = 0.389] between persons positive or negative for HIV. The viral load of HCV was, however, higher in older study subjects (r = 0.80, P = 0.000). HCV genotypes were determined using the VERSANT HCV Genotype Assay (LiPA) and sequence analysis of the NS5b region of the HCV genome. Diverse HCV genotypes were found including genotypes 1, 2, 4, and 5. There was no difference in the distribution regarding the HIV status. As in other parts of the world, genotyping of HCV must be considered whenever HCV is incriminated as a cause of hepatitis.

Laboratory malaria diagnostic capacity in health facilities in five administrative zones of Oromia Regional State, Ethiopia.

OBJECTIVES AND METHODS: Quality laboratory services are a requisite to guide rational case management of malaria. Using a pre-tested, standardized assessment tool, we assessed laboratory diagnostic capacity in 69 primary, secondary and tertiary health facilities as well as specialized laboratories in five administrative zones in Oromia Regional State, Ethiopia, during February and March 2009. RESULTS: There was marked variability in laboratory diagnostic capacity among the facilities assessed. Of 69 facilities surveyed, 53 provided both comprehensive malaria laboratory diagnosis and outpatient treatment services, five provided malaria microscopy services (referring elsewhere for treatment), and 11 primary care health posts provided rapid diagnostic testing and outpatient malaria treatment. The facilities' median catchment population was 39, 562 and 3581 people for secondary/tertiary and primary health facilities, respectively. Depending on facility type, facilities provided services 24 hrs a day, had inpatient capacity, and access to water and electricity. Facilities were staffed by general practitioners, health officers, nurses or health extension workers. Of the 58 facilities providing laboratory services, 24% of the 159 laboratory staff had received malaria microscopy training in the year prior to this survey, and 72% of the facilities had at least one functional electric binocular microscope. Facilities had variable levels of equipment, materials and biosafety procedures necessary for laboratory diagnosis of malaria. The mean monthly number of malaria blood films processed at secondary/tertiary facilities was 225, with a mean monthly 56 confirmed parasitologically. In primary facilities, the mean monthly number of clinical malaria cases seen was 75, of which 57 were tested by rapid diagnostic test (RDTs). None of the surveyed laboratory facilities had formal quality assurance/quality control protocols for either microscopy or RDTs. CONCLUSIONS: This is the first published report on malaria diagnostic capacity in Ethiopia. While our assessment indicated that malaria laboratory diagnosis was available in most facilities surveyed, we observed significant gaps in laboratory services which could significantly impact quality and accessibility of malaria diagnosis, including laboratory infrastructure, equipment, laboratory supplies and human resources.