Department of Chemical Pathology, University of the Witwatersrand, National Health Laboratory Services, Parktown, Johannesburg, South Africa
Gounden, V., Department of Chemical Pathology, University of the Witwatersrand, National Health Laboratory Services, Parktown, Johannesburg, South Africa; George, J., Department of Chemical Pathology, University of the Witwatersrand, National Health Laboratory Services, Parktown, Johannesburg, South Africa
Background: South Africa has the largest prevalence of HIV infected individuals in the world. The introduction of point of care testing to anti-retroviral (ARV) clinic sites is hoped to fast track initiation of patients on ARVs and to allow for earlier recognition of adverse effects such as dyslipidaemia, renal and hepatic dysfunction. Methods: We evaluated six instruments for the following analytes: glucose, lactate, creatinine, cholesterol, triglycerides, HDL-cholesterol, alanine transaminase (ALT), and glycated haemoglobin. Comparisons with the central laboratory analyser were performed as well as precision studies. A scoring system was developed by the authors to evaluate the instruments in terms of analytical performance, cost, ease of use, and other operational characteristics. As one of the goals of the placement of these instruments was that their operation was simple enough to be used by non-laboratory staff, ease of use contributed a large proportion to the final scoring. Results: Analytical performance of the POC analysers were generally similar, however, there were significant differences in operational characteristics and ease of use. Bias for the different analytes when compared to the laboratory analyser ranged from -27% to 14%. Calculated total errors for all analytes except for HDL cholesterol were within total allowable error recommendations. The two instruments (Roche Reflotron and Cholestech LDX) with the highest overall total points achieved the highest scores for ease of use. Conclusions: This pilot study has led to the development of a scoring system for the evaluation of POC instruments.
alanine aminotransferase; cholesterol; creatinine; glucose; glycosylated hemoglobin; high density lipoprotein cholesterol; lactic acid; triacylglycerol; alanine aminotransferase blood level; article; cholesterol blood level; comparative study; hospital; laboratory device; pilot study; point of care testing; scoring system; South Africa; Anti-Retroviral Agents; Blood Chemical Analysis; Drug Toxicity; Drug-Induced Liver Injury; Dyslipidemias; HIV Infections; Humans; Kidney Diseases; Pilot Projects; Point-of-Care Systems; Reproducibility of Results; Sensitivity and Specificity; South Africa; Task Performance and Analysis