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

淋巴丝虫病快速抗原诊断试验的实验室比较:STANDARD Q 丝虫病抗原试验 (QFAT) 与 Bioline 丝虫病试纸 (FTS)

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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 W. bancrofti 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 Dirofilaria repens and Onchocerca lupi but not with Acanthochilonema reconditum or Cercopithifilaria bainae. Under laboratory conditions, QFAT is a suitable alternative RDT to FTS.

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