Background Quantitative molecular assays are increasingly used for detection of enteric viruses. Methods We compared the clinical severity using modified Vesikari score (mVS) of enteric viruses detected by conventional assays (enzyme immunoassays [EIA] for rotavirus and adenovirus 40/41 and conventional polymerase chain reaction for astrovirus, sapovirus, and norovirus) and a quantitative molecular assay (TaqMan Array Card [TAC]) among children aged 0-59 months in the Global Enteric Multicenter Study. For rotavirus and adenovirus 40/41, we compared severity between EIA-positive and TAC-positive cases assigned etiologies using different cycle threshold (CT) cutoffs. Results Using conventional assays, the median (interquartile range) mVS was 10 (8, 11) for rotavirus, 9 (7, 11) for adenovirus 40/41, 8 (6, 10) for astrovirus, sapovirus, and norovirus GII, and 7 (6, 9) for norovirus GI. Compared to rotavirus EIA-positive cases, the median mVS was 2 and 3 points lower for EIA-negative/TAC-positive cases with CT<32.6 and 32.6≤CT<35, respectively (p-value<.0001). Adenovirus 40/41 EIA-positive and EIA-negative/TAC-positive cases were similar, regardless of CT cutoff. Conclusions Quantitative molecular assays compared to conventional assays, such as EIA, may influence severity of identified cases, especially for rotavirus. Cutoffs to assign etiology for quantitative assays should be considered in the design and interpretation of enteric virus studies.

中文翻译：

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全球肠道多中心研究中使用定量分子检测与传统检测相比检测肠道病毒的临床严重程度

背景定量分子测定越来越多地用于肠道病毒的检测。方法 我们使用传统检测（轮状病毒和腺病毒 40/41 的酶免疫分析 [EIA]，星状病毒、沙波病毒和诺如病毒的常规聚合酶链反应）检测到的肠道病毒的改良 Vesikari 评分 (mVS) 和定量分子检测来比较临床严重程度。全球肠道多中心研究中 0-59 个月龄儿童的检测（TaqMan 阵列卡 [TAC]）。对于轮状病毒和腺病毒 40/41，我们使用不同的循环阈值 (CT) 截止值比较了指定病因的 EIA 阳性和 TAC 阳性病例之间的严重程度。结果 使用常规检测，轮状病毒的 mVS 中位数（四分位距）为 10 (8, 11)，腺病毒 40/41 的 mVS 中位数为 9 (7, 11)，星状病毒、沙波病毒和诺如病毒 GII 的 mVS 中位数为 8 (6, 10)， 7 (6, 9) 诺如病毒胃肠道。与轮状病毒EIA阳性病例相比，CT＜32.6和32.6≤CT＜35的EIA阴性/TAC阳性病例的中位mVS分别低2分和3分(p值＜0.0001)。无论 CT 截止值如何，腺病毒 40/41 EIA 阳性和 EIA 阴性/TAC 阳性病例相似。结论 与 EIA 等传统检测相比，定量分子检测可能会影响已识别病例的严重程度，尤其是轮状病毒。在肠道病毒研究的设计和解释中应考虑为定量测定指定病因的截止值。