Verkerke Hans P, Hanbury Blake, Siddique Abdullah, Samie Amidou, Haque Rashidul, Herbein Joel, Petri William A
Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia, USA.
Techlab, Blacksburg, Virginia, USA.
J Clin Microbiol. 2015 Feb;53(2):493-7. doi: 10.1128/JCM.02836-14. Epub 2014 Nov 26.
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.
在临床和研究环境中，快速即时检测腹泻粪便中的肠道原生动物对于有效确定腹泻病因是很有必要的。我们分析了Techlab公司开发的第三代溶组织内阿米巴快速检测法检测从南非和孟加拉国独立研究人群中收集的粪便样本中阿米巴抗原的能力。我们将这种最近发布的快速检测法与Remel公司市售的ProSpecT溶组织内阿米巴微孔板检测法以及Techlab公司的溶组织内阿米巴II酶联免疫吸附测定（ELISA）的性能进行了比较，使用针对内阿米巴属物种的实时和巢式PCR来解决任何不一致的结果。在解决不一致结果后，与溶组织内阿米巴II ELISA相比，溶组织内阿米巴快速检测法的敏感性和特异性分别为98.0%（95%置信区间[CI]，92.9%至99.8%）和100%（95% CI，99.0%至100%）。与ProSpecT微孔板检测法相比，溶组织内阿米巴快速检测法的敏感性为97.0%（95% CI，91.5%至99.4%），特异性为100%（95% CI，99.0%至100%）。我们的结果表明，快速检测法是一种用于在未固定的冷冻临床粪便样本中特异性检测溶组织内阿米巴滋养体的可靠检测方法。
