Comparative assessment of immunochromatographic test kits using somatic antigens from adult Opisthorchis viverrini and IgG and IgG4 conjugates for serodiagnosis of human opisthorchiasis.

Comparative assessment of immunochromatographic test kits using somatic antigens from adult Opisthorchis viverrini and IgG and IgG4 conjugates for serodiagnosis of human opisthorchiasis.
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DOI:
10.1007/s00436-021-07224-6
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发表时间:
2021-08
影响因子:
2
通讯作者:
Intapan PM
Intapan PM
中科院分区:
医学3区
文献类型:
--
作者:
Phupiewkham W;Sadaow L;Sanpool O;Rodpai R;Yamasaki H;Ittiprasert W;Mann VH;Brindley PJ;Maleewong W;Intapan PM

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人类持续数十年的猫后睾吸虫和华支睾吸虫的慢性感染可能导致在胆管癌(CCA)之前危及生命的病理,胆管癌通常预后不良。血清学方法可为临床诊断提供寄生虫学检查的支持,并为CCA的风险筛查提供支持。我们开发了新的免疫层析试剂盒,使用可溶性的,体细胞组织提取物的成年O。用胶体金标记的IgG和IgG_4抗体偶联物检测了猫瘟病毒(Viverrini)的IgG和IgG_4抗体,并评价了OvSO-IgG和OvSO-IgG_4试剂盒的诊断价值。OvSO-IgG试剂盒诊断后睾吸虫病的敏感性、特异性、阳性和阴性预测值及95%可信区间均为86.6%(78.9-92.3),89.5%(84.2-93.5),82.9%(74.8-89.2)和91.9%(87.0-95.4),而75%在感染率为37.1%时,OvSO-IgG 4试剂盒分别为65.9-82.7)、98.4%(95.5-99.7)、96.6%(90.3-99.3)和87%(81.7-91.2)。30份华支睾吸虫病血清中,OvSO-IgG和OvSO-IgG 4试剂盒分别有23份(76.7%)和14份(46.7%)呈阳性反应。两种试剂盒之间的一致性为84.1%(κ值= 0.649),具有统计学显著性(p < 0.001)。两种ICT试剂盒均可用作快速简便的床旁诊断工具,因此OvSO-IgG和OvSO-IgG 4试剂盒可支持扩大人类后睾吸虫病和华支睾吸虫病的临床诊断能力。这些工具包可用于先进医疗设施或能力有限的地方病流行地区的大规模调查。
Chronic infections of humans with Opisthorchis viverrini and Clonorchis sinensis spanning decades may lead to life-threatening pathology prior to cholangiocarcinoma (CCA), which usually has a poor prognosis. Serological tools can support the parasitological examination in clinical diagnosis and support screening for risk of CCA. We developed novel immunochromatographic test kits using a soluble, somatic tissue extract of adult O. viverrini worms as an antigen and colloidal-gold labeled conjugates of IgG and IgG4 antibodies and evaluated the diagnostic values of both the OvSO-IgG and OvSO-IgG4 kits. For diagnosis of human opisthorchiasis individually, the diagnostic sensitivity, specificity, positive and negative predictive values with 95% confidence intervals in the OvSO-IgG kit were 86.6% (78.9-92.3), 89.5% (84.2-93.5), 82.9% (74.8-89.2), and 91.9% (87.0-95.4), respectively, while the 75% (65.9-82.7), 98.4% (95.5-99.7), 96.6% (90.3-99.3), and 87% (81.7-91.2), respectively, for the OvSO-IgG4 kit at the prevalence of infection of 37.1%. Twenty-three (76.7%) and 14 (46.7%) of 30 clonorchiasis sera showed positive reactivity with the OvSO-IgG and OvSO-IgG4 kits, respectively. There was 84.1% (κ-value = 0.649) concordance between the two kits, which was statistically significant (p < 0.001). Both ICT kits can be employed as quick and easy point-of-care diagnostic tools, and hence the OvSO-IgG and OvSO-IgG4 kits can support expanded capacity for clinical diagnosis of human opisthorchiasis and clonorchiasis. These kits may find utility in large-scale surveys in endemic areas where there are limited sophisticated medical facilities or capacity.
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