Sydney School of Veterinary Science, University of Sydney, Private Bag 4003, Narellan, NSW, 2567, Australia; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd., Bangkok, 10400, Thailand.
Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd., Bangkok, 10400, Thailand.
J Virol Methods. 2020 Dec;286:113975. doi: 10.1016/j.jviromet.2020.113975. Epub 2020 Sep 18.
African Swine Fever (ASF) is a transboundary animal disease of pigs and wild suids that appeared in Lao People's Democratic Republic (Lao PDR) in mid-2019, having spread across China and Vietnam in the months prior. Despite the scale of the Asian ASF pandemic and the availability of pen-side rapid diagnostic tests (RDT) on the market, few locally produced and easily available ASF RDTs have been evaluated for diagnostic accuracy. In this study, an ASF antigen detection RDT from Shenzhen Lvshiyuan Biotechnology Co. Ltd was evaluated using clinical field samples submitted to the National Animal Health Laboratory (NAHL) from ASF suspect cases between June and December 2019 in Lao PDR. Positive (n = 57) and negative (n = 50) samples of whole blood, serum and haemolysed serum were assessed by RDT and PCR, with the latter used as the gold standard reference comparator. Overall the RDT had a diagnostic sensitivity (DSe) of 65 %, 95 % CI [51-77] and diagnostic specificity (DSp) of 76 %, 95 % CI [62-87]. The RDT demonstrated improved performance on samples with lower PCR cycle threshold (ct) values with each additional cycle reducing the odds of the RDT returning a positive by 17 % relative to the previous cycle, 95 % CI [8 %-28 %] (P < 0.01). While this test shows promise for field application, complete validation of diagnostic accuracy requires a larger sample size.
非洲猪瘟（ASF）是一种猪和野猪的跨境动物疾病，于 2019 年年中在老挝人民民主共和国（老挝）出现，在此之前，ASF 已在中国和越南蔓延。尽管亚洲 ASF 大流行的规模很大，市场上也有现成的快速床边诊断检测（RDT），但很少有针对诊断准确性进行评估的本地生产且易于获得的 ASF RDT。在这项研究中，使用来自深圳绿诗源生物技术有限公司的 ASF 抗原检测 RDT，对 2019 年 6 月至 12 月期间老挝国家动物卫生实验室（NAHL）提交的 ASF 疑似病例的临床现场样本进行了评估。RDT 检测了 57 份全血、血清和溶血血清阳性样本和 50 份阴性样本，并与 PCR 进行了比较，后者作为金标准参考对照。总体而言，RDT 的诊断敏感性（DSe）为 65%，95%置信区间[51-77]，诊断特异性（DSp）为 76%，95%置信区间[62-87]。RDT 在 PCR 循环阈值（ct）值较低的样本中表现出更好的性能，每个额外的循环会使 RDT 呈阳性的几率降低 17%，95%置信区间[8%-28%]（P<0.01）。虽然该检测方法具有现场应用的潜力，但要完全验证诊断准确性还需要更大的样本量。
