Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.
Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
Virol J. 2023 Mar 3;20(1):40. doi: 10.1186/s12985-023-01999-z.
Rotavirus A (RVA) infections remain a major cause of severe acute diarrhea affecting children worldwide. To date, rapid diagnostic tests (RDT) are widely used to detect RVA. However, paediatricians question whether the RDT can still detect the virus accurately. Therefore, this study aimed to evaluate the performance of the rapid rotavirus test in comparison to the one-step RT-qPCR method.
A cross-sectional study was conducted in Lambaréné, Gabon, from April 2018 to November 2019. Stool samples were collected from children under 5 years of age with diarrhoea or a history of diarrhoea within the last 24 h, and from asymptomatic children from the same communities. All stool samples were processed and analysed using the SD BIOLINE Rota/Adeno Ag RDT against a quantitative reverse transcription PCR (RT-qPCR), which is considered the gold standard.
For a total of 218 collected stool samples, the overall sensitivity of the RDT was 46.46% (confidence interval (CI) 36.38-56.77), with a specificity of 96.64% (CI 91.62-99.08) compared to one-step RT-qPCR. After confirming the presence or absence of RVA gastroenteritis, the RDT showed suitable results in detecting rotavirus A-associated disease, with a 91% concordance with the RT-qPCR. Furthermore, the performance of this test varied when correlated with seasonality, symptoms, and rotavirus genotype.
This RDT showed high sensitivity and was suitable for the detection of RVA in patients with RVA gastroenteritis, although some asymptomatic RVA shedding was missed by RT-qPCR. It could be a useful diagnostic tool, especially in low-income countries.
轮状病毒 A（RVA）感染仍然是全球儿童严重急性腹泻的主要原因。迄今为止，快速诊断检测（RDT）已广泛用于检测 RVA。然而，儿科医生质疑 RDT 是否仍然能够准确检测病毒。因此，本研究旨在评估快速轮状病毒检测与一步法 RT-qPCR 方法的性能比较。
本研究为 2018 年 4 月至 2019 年 11 月在加蓬兰巴雷内进行的横断面研究。采集了 5 岁以下腹泻或 24 小时内有腹泻史的儿童以及来自同一社区的无症状儿童的粪便样本。所有粪便样本均使用 SD BIOLINE Rota/Adeno Ag RDT 进行处理和分析，与定量逆转录聚合酶链反应（RT-qPCR）相比，后者被认为是金标准。
共采集 218 份粪便样本，与一步法 RT-qPCR 相比，RDT 的总体灵敏度为 46.46%（置信区间（CI）为 36.38%-56.77%），特异性为 96.64%（CI 为 91.62%-99.08%）。在确认存在或不存在轮状病毒胃肠炎后，RDT 在检测轮状病毒 A 相关疾病方面显示出合适的结果，与 RT-qPCR 的一致性为 91%。此外，该检测的性能与季节性、症状和轮状病毒基因型相关。
该 RDT 显示出较高的灵敏度，适用于检测 RVA 胃肠炎患者中的 RVA，尽管一些无症状的 RVA 脱落被 RT-qPCR 漏检。它可能是一种有用的诊断工具，特别是在低收入国家。
