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评估 SsIR/NIE 重组抗原 ELISA 对感染 : 的患者进行随访的效果——一项诊断研究。

Evaluation of the SsIR/NIE recombinant antigen ELISA for the follow up of patients infected by : a diagnostic study.

机构信息

Department of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Verona, Negrar di Valpolicella, Italy.

出版信息

Parasitology. 2024 Mar;151(3):295-299. doi: 10.1017/S0031182024000027. Epub 2024 Jan 8.

Abstract

Some serology assays demonstrated useful for post-treatment monitoring of infection. Serology frequently has low specificity, which might be improved by the use of recombinant antigens. The Strongy Detect ELISA is based on 2 recombinant antigens (SsIR and NIE) and proved good accuracy. Aim of this study was to evaluate the performance of this test for the post-treatment monitoring of strongyloidiasis. We tested 38 paired sera, with matched fecal tests results, stored in our biobank and originating from a randomized controlled trial. At baseline, all patients tested positive for at least 1 fecal assay among PCR, direct stool microscopy and agar plate culture. Patients were re-tested with both serology and fecal assays 12 months after treatment. Primary outcome was the relative reduction in optical density (OD) between baseline and follow up. We observed that about 95% samples showed a reduction between pre and post-treatment OD, with a median relative reduction of 93.9% (IQR 77.3%–98.1%). In conclusion, the test proved reliable for post-treatment monitoring. However, some technical issues, including that the threshold for positivity has not be predefined, and that a substantial number of samples showed overflow signals, need to be fixed to permit use in routine practice.

摘要

一些血清学检测方法在感染后的治疗监测中具有一定的作用。血清学检测的特异性通常较低,而使用重组抗原可以提高其特异性。Strongy Detect ELISA 检测基于 2 种重组抗原(SsIR 和 NIE),具有良好的准确性。本研究旨在评估该检测方法在治疗后监测钩虫病中的应用价值。我们检测了 38 对血清样本,这些血清样本与我们生物库中储存的、来自随机对照试验的粪便检测结果相匹配。在基线时,所有患者的至少 1 种粪便检测(PCR、直接粪便显微镜检查和琼脂平板培养)均呈阳性。治疗 12 个月后,患者同时接受血清学和粪便学检测。主要结局是治疗前后 OD 值的相对降低。我们观察到约 95%的样本在治疗前后的 OD 值有降低,中位数相对降低率为 93.9%(IQR 77.3%–98.1%)。综上所述,该检测方法在治疗后监测中具有较高的可靠性。然而,一些技术问题,包括阳性阈值尚未预先设定,以及大量样本显示溢出信号,需要加以解决,以便在常规实践中使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0770/11007275/cd992eebeb7d/S0031182024000027_figAb.jpg

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