Nantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l'Immunité, IICiMed, UR1155, 44000 Nantes, France.
Laboratoire de Parasitologie-Mycologie, Centre de Biologie, CHU Gabriel Montpied, 58 rue Montalembert, 63000 Clermont-Ferrand, France.
Parasite. 2022;29:27. doi: 10.1051/parasite/2022026. Epub 2022 May 13.
We provide the first evaluation of the CE-IVD marked Novodiag stool parasites assay (NVD), allowing rapid and high-plex detection of 26 distinct targets, encompassing protozoans, helminths and microsporidia in stool samples.
A total of 254 samples (n = 205 patients) were prospectively processed by the NVD and our routine procedure (RP). Performances of the NVD were compared with RP. Samples only positive by the NVD assay were investigated by external PCR assays. Sensitivity and specificity (Se/Sp) and time from sample receipt to results were determined for each method. The NVD was also evaluated against 77 additional samples positive for a wide range of parasites.
Overall positivity rate was 16.9% for RP compared with 34% using the NVD assay, and 164 samples (66%) were negative by both methods. Only 30 positive samples (12%) showed full concordance between RP and NVD. Fifty-three discordant samples were sent for external investigations. Except for Giardia intestinalis and Trichuris spp., higher Se was observed for the NVD assay for Blastocystis spp. (100% vs. 63%), Dientamoeba fragilis (100% vs. 0%), Schistosoma spp. (100% vs. 17%), and Enterobius vermicularis (100% vs. 67%) but roughly similar to RP for the remaining parasites tested. False-positive results were identified for Blastocystis spp., G. intestinalis, and Trichuris spp. using the NVD assay. The NVD mostly provides a diagnosis on the day of sample receipt compared with a mean of three days with RP.
Besides some limitations, the NVD is a new diagnostic strategy allowing rapid and high-plex detection of gastrointestinal parasites from unpreserved stools.
我们首次评估了 CE-IVD 标记的诺维迪亚粪便寄生虫检测试剂盒（NVD），该试剂盒能够快速、高灵敏地检测粪便样本中的 26 种不同目标，包括原生动物、蠕虫和微孢子虫。
共前瞻性地处理了 254 个样本（n=205 例患者），采用 NVD 和我们的常规程序（RP）。将 NVD 的性能与 RP 进行比较。仅通过 NVD 检测呈阳性的样本通过外部 PCR 检测进行调查。确定了每种方法的灵敏度和特异性（Se/Sp）以及从样本接收至结果的时间。还针对 77 个额外的广泛寄生虫阳性样本评估了 NVD。
RP 的总体阳性率为 16.9%，而 NVD 检测的阳性率为 34%，两种方法均为阴性的样本有 164 个（66%）。仅 30 个阳性样本（12%）在 RP 和 NVD 之间显示完全一致。53 个不一致的样本被送去进行外部调查。除了肠贾第鞭毛虫和鞭虫外，NVD 检测对蓝氏贾第鞭毛虫（100% vs. 63%）、脆弱双核阿米巴（100% vs. 0%）、血吸虫（100% vs. 17%）和蠕形住肠线虫（100% vs. 67%）的灵敏度更高，但对其余测试的寄生虫与 RP 大致相似。使用 NVD 检测试剂盒会对蓝氏贾第鞭毛虫、肠贾第鞭毛虫和鞭虫产生假阳性结果。与 RP 相比，NVD 通常可以在样本接收当天提供诊断，而 RP 的平均时间为三天。
除了一些限制外，NVD 是一种新的诊断策略，能够快速、高灵敏地检测未保存粪便中的胃肠道寄生虫。
