Dataset of the performance of Ov16 RDTs, Gabon, 2015

Skin snip biopsies remain the gold standard for the diagnosis of active infection with Onchocerca volvulus. However, in low-prevalence settings, such as after several rounds of mass drug administration of ivermectin, the sensitivity of skin snipping is low, and the procedure is poorly tolerated. Detection of Ov16 IgG4 antibodies from whole blood or dried blood spots (DBS) via rapid diagnostic test (RDT) or enzyme linked immunosorbent assay (ELISA), respectively, may therefore provide a more sensitive tool for the assessment of elimination (interruption) of transmission (EoT). RDTs require little training and resources to deploy and are therefore favoured by policy makers in Lower-Middle Income Countries (LMICs). This dataset was compiled from individual-based surveys conducted across 67 villages in Gabon in 2015, aiming to compare the performance of skin snipping versus that of Ov16 RDTs and ELISAs. Gabon had not received MDA but features many implementation units (IU) with hypoendemic (<35% microfilarial prevalence) transmission. Local healthcare centres conducted the surveys. The initial participant pool totaled 5,289 individuals, with a median age of 30 years (Interquartile Range (IQR): 11-55 years). Skin snips were obtained from 4,350 individuals (sheet 1), and RDTs were performed on blood samples collected from 4,257 individuals. 337 individuals (8%) gave a positive skin snip, with 383 individuals (9%) recording a positive Ov16 RDT. Of these, 174 individuals tested positive in both tests, giving the RDT an overall sensitivity of 52% and specificity of 95%. Sheet 2 shows the data aggregated at the village level. Sheet 3 shows the Ov16 ELISA data. Horse radish peroxidase (HRP) Ov16 ELISAs were conducted on DBS in 58 (87%) of the 67 villages. A total of 2,714 individuals (70% of those participants who had concordant RDT and skin snip results) underwent ELISA testing, producing 167 (6%) Ov16 positive results. These data highlight, that whilst broadly efficacious, there is a need for caution on the reliance of RDTs in determination of EoT and furthers calls for the development of a novel RDT, with a diagnostic profile providing higher sensitivity and specificity values.皮肤剪样活检（skin snip biopsy）仍是盘尾丝虫（Onchocerca volvulus）活动性感染诊断的金标准。然而在诸如多轮伊维菌素大规模药物投放（mass drug administration, MDA）后的低流行地区，皮肤剪样活检的灵敏度较低，且受试者耐受性较差。因此，分别采用快速诊断检测（rapid diagnostic test, RDT）与酶联免疫吸附试验（enzyme linked immunosorbent assay, ELISA）检测全血或干血斑（dried blood spots, DBS）中的Ov16 IgG4抗体，可作为评估传播阻断（elimination of transmission, EoT）的更灵敏工具。RDT部署所需培训与资源成本极低，因此受中低收入国家（Lower-Middle Income Countries, LMICs）政策制定者青睐。本数据集源自2015年在加蓬67个村庄开展的基于个体的调查，旨在对比皮肤剪样活检与Ov16 RDT、ELISA的诊断效能。加蓬此前未开展过MDA，但拥有多个实施单元（implementation unit, IU），其传播状态为低流行（微丝蚴感染率<35%）。本次调查由当地医疗中心实施。初始参与队列共5289人，年龄中位数为30岁（四分位距（Interquartile Range, IQR）：11~55岁）。研究人员为4350名受试者采集了皮肤剪样样本（详见工作表1），并对4257名受试者的血液样本开展了RDT检测。其中337人（8%）皮肤剪样检测结果呈阳性，383人（9%）Ov16 RDT结果呈阳性；174名受试者两项检测均呈阳性，据此计算RDT的总体灵敏度为52%，特异度为95%。工作表2展示了按村庄汇总的数据集，工作表3则包含Ov16 ELISA检测数据。研究人员在67个村庄中的58个（占比87%）开展了辣根过氧化物酶（Horse radish peroxidase, HRP）标记的Ov16 ELISA检测，检测样本为DBS。共有2714名受试者（占RDT与皮肤剪样检测结果一致者的70%）接受了ELISA检测，其中167人（6%）Ov16检测结果呈阳性。本研究数据表明，尽管RDT整体具备一定诊断效能，但在用于判定EoT时仍需谨慎；同时，本研究进一步呼吁开发兼具更高灵敏度与特异度的新型RDT。