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淋巴丝虫病快速抗原诊断检测的实验室比较:标准Q丝虫病抗原检测(QFAT)与Bioline丝虫病检测试纸条(FTS)

Laboratory Comparison of Rapid Antigen Diagnostic Tests for Lymphatic Filariasis: STANDARD Q Filariasis Antigen Test (QFAT) Versus Bioline Filariasis Test Strip (FTS).

作者信息

Graves Patricia M, Scott Jessica L, Berg Soto Alvaro, Widi Antin Y N, Whittaker Maxine, Lau Colleen L, Won Kimberly Y

机构信息

WHO Collaborating Centre for Vector-Borne and Neglected Tropical Diseases, College of Public Health, Medical and Veterinary Sciences and Australian Institute of Tropical Health and Medicine, James Cook University, Cairns, QLD 4878, Australia.

Andes Analytics, Santiago 7560408, Chile.

出版信息

Trop Med Infect Dis. 2025 Jan 14;10(1):23. doi: 10.3390/tropicalmed10010023.

Abstract

Accurate rapid diagnostic tests (RDTs) are needed to diagnose lymphatic filariasis (LF) in global elimination programmes. We evaluated the performance of the new STANDARD Q Filariasis Antigen Test (QFAT) against the Bioline Filariasis Test Strip (FTS) for detecting antigen (Ag) in laboratory conditions, using serum (n = 195) and plasma (n = 189) from LF-endemic areas (Samoa, American Samoa and Myanmar) and Australian negative controls (n = 46). The prior Ag status of endemic samples (54.9% Ag-positive) was determined by rapid test (ICT or FTS) or Og4C3 ELISA. The proportion of samples testing positive at 10 min was similar for QFAT (44.8%) and FTS (41.3%). Concordance between tests was 93.5% (kappa 0.87, n = 417) at 10 min, and it increased to 98.8% (kappa 0.98) at 24 h. The sensitivities of QFAT and FTS at 10 min compared to the prior results were 92% (95% CI 88.0-96.0) and 86% (95% CI 80.0-90.0), respectively, and they increased to 97% and 99% at 24 h. Specificity was 98% for QFAT and 99% for FTS at 10 min. Both tests showed evidence of cross-reaction with and but not with or Under laboratory conditions, QFAT is a suitable alternative RDT to FTS.

摘要

在全球消除淋巴丝虫病(LF)计划中,需要准确的快速诊断检测(RDT)来诊断该病。我们在实验室条件下,使用来自LF流行地区(萨摩亚、美属萨摩亚和缅甸)的血清(n = 195)和血浆(n = 189)以及澳大利亚阴性对照(n = 46),评估了新型标准Q丝虫病抗原检测(QFAT)相对于Bioline丝虫病检测试纸(FTS)检测抗原(Ag)的性能。流行地区样本(54.9% Ag阳性)的先前Ag状态通过快速检测(ICT或FTS)或Og4C3 ELISA确定。在10分钟时,QFAT(44.8%)和FTS(41.3%)检测呈阳性的样本比例相似。两种检测在10分钟时的一致性为93.5%(kappa值为0.87,n = 417),在24小时时增至98.8%(kappa值为0.98)。与先前结果相比,QFAT和FTS在10分钟时的敏感性分别为92%(95% CI 88.0 - 96.0)和86%(95% CI 80.0 - 90.0),在24小时时分别增至97%和99%。在10分钟时,QFAT的特异性为98%,FTS的特异性为99%。两种检测均显示出与[具体物质1]和[具体物质2]有交叉反应的证据,但与[具体物质3]或[具体物质4]没有交叉反应。在实验室条件下,QFAT是FTS合适的替代RDT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4456/11768758/b759b64f787d/tropicalmed-10-00023-g001.jpg

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