Quality of HIV Serology and Malaria Testing by Clinical Laboratories in Wakiso District, Uganda

Abstract

Background: Provision of quality laboratory services is a critical need for early diagnosis and control of disease. In many resource-constrained countries like Uganda, the quality of laboratory services is usually compromised by low staffing levels and lack of strong systems, equipment and utilities. In addition, assessment for adherence to laboratory standards such as Good Clinical Laboratory Practices and Standards is low. Objectives: To assess the quality of HIV serology and malaria testing by laboratories in Wakiso district. Methods: A facility assessment checklist was used to assess adherence to GCLP and standards. Specimens pre-tested at a reference laboratory were used to check for accuracy of HIV serology and malaria testing at health facilities laboratories. Semi structured interviews were then carried out with focal persons to provide information on the factors that affect accuracy of HIV serology and malaria testing in the clinical laboratories in Wakiso district. Results: All laboratories scored highly in the structural attributes of the quality paradigm such as quality control, environment and safety. The least scoring structure attributes was availability of equipment. Under the process paradigm, adherence to SOPs was greatly lacking and 50/61 testers did not carry out the tests as specified. Compliance with GCLP guidelines was more observed in PNFP laboratories, followed by government labs and then private laboratories. The overall concordance of HIV serology testing and malaria testing was 96% and 83% respectively. Inaccurate HIV serology results were obtained at government funded laboratories (3/79 tests performed). Inaccurate malaria results were obtained in 3/58 laboratories. None of the laboratories that received specimens with high malaria parasite loads returned accurate counts. There was inconsistency in the reporting of malaria results across the laboratories surveyed. The major challenges with HIV serology testing experienced by laboratories in Wakiso district were stock out of testing kits, challenges with the kits in the nationally approved algorithm and clients doubting the authenticity of the laboratory results being given to them. Challenges with malaria testing stemmed from stock outs of mRDTs, pressure from clients to report specific result and inconsistencies between the mRDT and microscopy malaria testing methods. Conclusion: Overall, the laboratories in Wakiso produced accurate HIV serology and malaria test results as shown by the high concordance with reference results. Compliance to GCLP standards for clinical laboratories was high however, there were still deficits in availability of equipment and SOPs. The factors that were most commonly reported to affect quality of HIV serology and malaria testing were stock-outs of testing kits and pressure from clients to report a specific result. Expansion of external quality assurance schemes for HIV serology and creation of a scheme for malaria testing would reduce the factors that could potentially affect the quality of laboratory services in Wakiso District.