Dataset of the performance of Ov16 RDTs versus skin snip microscopy and Ov16 ELISA, 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 5,829 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 3,012 individuals underwent ELISA testing, producing 348 (12%) 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.皮肤剪活检（skin snip biopsy）仍是诊断盘尾丝虫（Onchocerca volvulus）现症感染的金标准。然而在低流行地区，例如经过多轮伊维菌素大规模药物治疗（MDA）后，皮肤剪活检的灵敏度较低，且该操作的患者耐受性较差。 因此，分别通过快速诊断试验（rapid diagnostic test, RDT）检测全血样本、酶联免疫吸附试验（enzyme linked immunosorbent assay, ELISA）检测干血斑（dried blood spots, DBS）中的Ov16 IgG4抗体，或可成为评估传播消除（即传播阻断，EoT）的更灵敏检测手段。RDT的部署仅需少量培训与资源，因此受到中低收入国家（Lower-Middle Income Countries, LMICs）政策制定者的青睐。 本数据集汇编自2015年在加蓬67个村庄开展的基于个体的调查，旨在对比皮肤剪活检与Ov16 RDT、ELISA的诊断效能。 加蓬未接受过MDA，但其存在多个实施单元（implementation unit, IU），这些单元存在微丝蚴阳性率低于35%的低流行传播情况。当地医疗中心负责开展本次调查。初始招募的参与者共计5829名，年龄中位数为30岁（四分位间距（Interquartile Range, IQR）：11~55岁）。 研究人员为4350名个体采集了皮肤剪活检样本（工作表1），并对4257名个体的血液样本实施了RDT检测。 其中337名（8%）个体的皮肤剪活检结果呈阳性，383名（9%）个体的Ov16 RDT结果呈阳性。在上述阳性人群中，有174名两项检测均呈阳性，据此计算得到RDT的总体灵敏度为52%、特异度为95%。 工作表2展示了按村庄水平汇总的数据集，工作表3则展示了Ov16 ELISA检测数据。研究人员对67个村庄中的58个（87%）的DBS样本开展了辣根过氧化物酶（Horse radish peroxidase, HRP）标记的Ov16 ELISA检测。总计3012名个体接受了ELISA检测，其中348名（12%）结果呈Ov16阳性。 上述数据表明，尽管RDT整体具备诊断效能，但在依托RDT判定EoT时仍需保持谨慎，同时也进一步呼吁开发具备更高灵敏度与特异度的新型RDT。