Allahham Majd, Rennert Wolfgang, Miller Kiija Manty, Barham Mustafa, Amoss William, Hindiyeh Musa
Laboratory Department, Caritas Baby Hospital, Bethlehem, Palestine.
Rostropovich-Vishnevskaya Foundation, Washington, USA.
Eur J Clin Microbiol Infect Dis. 2025 Apr;44(4):839-845. doi: 10.1007/s10096-025-05042-7. Epub 2025 Jan 24.
Rotavirus (RV) and Adenovirus (AdV) gastroenteritis affect children worldwide. The sensitivity and specificity of the AMP Rapid Test ROTA/ADENOVIRUS [AMP-RA] for the detection of RV and AdV were compared against qPCR Allplex™ GI-Virus Assay [Allplex-GI].
A cross-sectional hospital-based surveillance study was conducted using stool samples from 1,148 patients under the age of five years between July 2023 and May 2024 with gastroenteritis. All samples were tested using the AMP-RA and challenged with the Allplex-GI that detects rotavirus A, enteric adenovirus F, norovirus genogroups GI & GII, sapovirus, and astrovirus. RV samples testing positive by AMP-RA and/or Allplex-GI were subjected to genotyping.
Of the 1,148 stool samples, 123 samples tested positive for RV on AMP-RA while 133 tested positive on the Allplex™ GI. The clinical sensitivity and positive predictive value (PPV) of the AMP-RA for the detection of RV were 92.4% and 100%, respectively, while, the clinical specificity and negative predictive value (NPV) of the AMP-RA kit were 100% and 99%, respectively. The AMP-RA was able to detect all RV genotypes that circulated (G1[P8], G2[P4], G9[P8], G9[P4], G9[P9]). The AMP-RA assay detected 48 positive AdV samples and failed to detect 28 samples. Thus, the clinical sensitivity and PPV were 63.1% and 24.6%, respectively. 147 samples were positive for AdV on AMP-RA and negative by Allplex-GI, indicating a clinical specificity and NPV of 86.2% and 97.1%, respectively.
AMP-RA showed high diagnostic sensitivity and specificity for RV detection. The reliability of detecting AdV was insufficient, emphasizing the need for further adenovirus test improvement.
轮状病毒（RV）和腺病毒（AdV）肠胃炎影响着全球儿童。将AMP快速检测轮状病毒/腺病毒检测试剂[AMP-RA]检测RV和AdV的灵敏度和特异性与qPCR全基因组肠道病毒检测试剂盒[Allplex-GI]进行比较。
采用横断面医院监测研究，收集2023年7月至2024年5月期间1148例5岁以下肠胃炎患儿的粪便样本。所有样本均使用AMP-RA进行检测，并使用Allplex-GI进行验证，Allplex-GI可检测A组轮状病毒、肠道腺病毒F、诺如病毒GI和GII基因组、札幌病毒和星状病毒。对AMP-RA和/或Allplex-GI检测呈阳性的RV样本进行基因分型。
在1148份粪便样本中，123份样本经AMP-RA检测RV呈阳性，133份样本经Allplex™ GI检测呈阳性。AMP-RA检测RV的临床灵敏度和阳性预测值（PPV）分别为92.4%和100%，而AMP-RA试剂盒的临床特异性和阴性预测值（NPV）分别为100%和99%。AMP-RA能够检测到所有流行的RV基因型（G1[P8]、G2[P4]、G9[P8]、G9[P4]、G9[P9]）。AMP-RA检测出48份AdV阳性样本，未检测出28份样本。因此，临床灵敏度和PPV分别为63.1%和24.6%。147份样本经AMP-RA检测AdV呈阳性，但经Allplex-GI检测为阴性，表明临床特异性和NPV分别为86.2%和97.1%。
AMP-RA在检测RV方面显示出较高的诊断灵敏度和特异性。检测AdV的可靠性不足，强调需要进一步改进腺病毒检测方法。
