Verkerke H.P., Hanbury B., Siddique A., Samie A., Haque R., Herbein J., Petri W.A., Jr.
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States; Techlab, Blacksburg, VA, United States; Parasitology, International Center for Diarrheal Disease Research, Dhaka, Bangladesh; University of Venda, Limpopo Province, South Africa
Verkerke, H.P., Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States; Hanbury, B., Techlab, Blacksburg, VA, United States; Siddique, A., Parasitology, International Center for Diarrheal Disease Research, Dhaka, Bangladesh; Samie, A., University of Venda, Limpopo Province, South Africa; Haque, R., Parasitology, International Center for Diarrheal Disease Research, Dhaka, Bangladesh; Herbein, J., Techlab, Blacksburg, VA, United States; Petri, W.A., Jr., Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, United States
Rapid point-of-care detection of enteric protozoa in diarrheal stool is desirable in clinical and research settings to efficiently determine the etiology of diarrhea. We analyzed the ability of the third-generation E. histolytica Quik Chek assay developed by Techlab to detect amebic antigens in fecal samples collected from independent study populations in South Africa and Bangladesh. We compared the performance of this recently released rapid test to that of the commercially available ProSpecT Entamoeba histolytica microplate assay from Remel and the E. histolytica II enzyme-linked immunosorbent assay (ELISA) from Techlab, using real-time and nested-PCR for Entamoeba species to resolve any discrepant results. After discrepant resolution, The E. histolytica Quik Chek assay exhibited sensitivity and specificity compared to the E. histolytica II ELISA of 98.0% (95% confidence interval [CI], 92.9% to 99.8%) and 100% (95% CI, 99.0% to 100%), respectively. Compared to the ProSpecT microplate assay, the E. histolytica Quik Chek (Quik Chek) assay exhibited 97.0% sensitivity (95% CI, 91.5% to 99.4%) and 100% specificity (95% CI, 99.0% to 100%). Our results indicate that the Quik Chek is a robust assay for the specific detection of E. histolytica trophozoites in unfixed frozen clinical stool samples. © 2015, American Society for Microbiology. All Rights Reserved.
adult; amebiasis; Article; Bangladesh; controlled study; cross reaction; diagnostic test accuracy study; Entamoeba histolytica; enzyme linked immunosorbent assay; feces analysis; feces culture; female; human; immunoassay analyzer; intermethod comparison; major clinical study; male; microplate reader; point of care testing; polymerase chain reaction; rapid test; sensitivity and specificity; South Africa; species difference; validation study; Entamoeba; Entamoeba histolytica; Protozoa