Rotavirus is the leading cause of morbidity and mortality due to acute gastroenteritis among children under five years globally. Early diagnosis of rotavirus infection minimizes its spread and helps to determine the appropriate management of diarrhea. The aim of this study was to evaluate the performance of EpiTuub® Fecal Rotavirus Antigen Rapid Test Kit for the diagnosis of rotavirus infection among diarrheic children under five years in Ethiopian healthcare settings. A total of 537 children with diarrhea were enrolled from three referral hospitals in Amhara National Regional State, Ethiopia. The samples were tested using one-step RT-PCR and EpiTuub® Fecal Rotavirus Antigen Rapid Test Kit (KTR-917, Epitope Diagnostics, San Diego USA) in parallel. Diagnostic performance of the rapid test kit was evaluated using the one-step RT-PCR as a gold standard. The sensitivity, specificity, and predictive values of the rapid test kit were determined. Moreover, the agreement of the rapid test kit with one step RT-PCR was determined by kappa statistics and receiver operators' curve (ROC) analysis was done to assess the overall diagnostic accuracy of the rapid test kit. Fecal Rotavirus Antigen Rapid Test Kit has shown a sensitivity of 75.5% and specificity of 98.2%. The kit was also found to have 89.9% and 95.0% positive and negative predictive values, respectively. The Fecal Rotavirus Antigen Rapid Test Kit has shown a substantial agreement (78.7%, p = 0.0001) with one-step RT-PCR. The overall accuracy of the Fecal Rotavirus Antigen Rapid Test Kit was excellent with the area under the ROC curve of 86.9% (95% CI = 81.6, 92.1%) (p = .0001). Thus, Fecal Rotavirus Antigen Rapid Test is a sensitive, specific, user-friendly, rapid, and equipment-free option to be used at points of care in Ethiopian health care settings where resource is limited precluding the use of one step RT-PCR. Furthermore, the kit could be used in the evaluation and monitoring of rotavirus vaccine effectiveness in the aforementioned settings.

中文翻译：

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埃塞俄比亚阿姆哈拉国家地区 EpiTuub® 粪便轮状病毒抗原快速检测试剂盒的诊断性能评估：一项多中心横断面研究。

轮状病毒是全球五岁以下儿童急性胃肠炎发病和死亡的主要原因。轮状病毒感染的早期诊断可以最大限度地减少其传播，并有助于确定适当的腹泻治疗方法。本研究的目的是评估 EpiTuub® 粪便轮状病毒抗原快速检测试剂盒诊断埃塞俄比亚医疗机构五岁以下腹泻儿童轮状病毒感染的性能。埃塞俄比亚阿姆哈拉国家地区的三家转诊医院共招募了 537 名腹泻儿童。使用一步 RT-PCR 和 EpiTuub® 粪便轮状病毒抗原快速检测试剂盒（KTR-917，Epitope Diagnostics，圣地亚哥美国）并行测试样品。使用一步 RT-PCR 作为金标准评估快速检测试剂盒的诊断性能。确定了快速检测试剂盒的敏感性、特异性和预测值。此外，通过kappa统计确定快速检测试剂盒与一步RT-PCR的一致性，并进行受试者操作曲线（ROC）分析以评估快速检测试剂盒的整体诊断准确性。粪便轮状病毒抗原快速检测试剂盒的灵敏度为 75.5%，特异性为 98.2%。该试剂盒的阳性预测值和阴性预测值分别为 89.9% 和 95.0%。粪便轮状病毒抗原快速检测试剂盒与一步 RT-PCR 基本一致（78.7%，p = 0.0001）。粪便轮状病毒抗原快速检测试剂盒的总体准确性非常出色，ROC 曲线下面积为 86.9% (95% CI = 81.6, 92.1%) (p = .0001)。因此，粪便轮状病毒抗原快速检测是一种灵敏、特异、用户友好、快速且无需设备的选择，可在资源有限、无法使用一步 RT-PCR 的埃塞俄比亚医疗机构的护理点使用。此外，该试剂盒还可用于评估和监测上述环境中轮状病毒疫苗的有效性。