Field comparison of STANDARDTM Q Filariasis Antigen Test (QFAT) with Bioline Filariasis Test Strip (FTS) for the detection of Lymphatic Filariasis in Samoa, 2023

Jessica L Scott,Helen J Mayfield,Jane Sinclair, Beatris Mario Martin, Maddison Howlett, Ramona Muttucumaru,Kimberly Y Won,Robert Thomsen,Satupaitea Viali, Rossana Tofaeono-Pifeleti,Patricia M Graves,Colleen L Lau

medrxiv(2024)

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摘要
Background: To monitor the progress of lymphatic filariasis (LF) elimination programmes, field surveys to assess filarial antigen (Ag) prevalence require access to reliable, user-friendly rapid diagnostic tests. We aimed to evaluate the performance of the new Q Filariasis Antigen Test (QFAT) with the currently recommended Filariasis Test Strip (FTS) for detecting the Ag of Wuchereria bancrofti , the causative agent of LF, under field conditions. Methodology/Principal Findings: During an LF survey in Samoa, 344 finger-prick blood samples were tested using FTS and QFAT. Microfilariae (Mf) status was determined from blood slides prepared from Ag-positive samples. Each test was re-read at 1 hour and the next day to determine the stability of results over time. Overall Ag-positivity by FTS was 29% and 30% by QFAT. Concordance between the two tests was 94% (Kappa=0.85). Of the 105 Mf slides available, 38.1% were Mf-positive, and all were Ag-positive by both tests. Darker test line intensities from Ag-positive FTS were found to predict Mf-positivity (compared to same/lighter line intensities). QFAT had significantly higher reported test result changes than FTS, mostly reported the next day. The field laboratory team preferred QFAT over FTS due to the smaller blood volume required, better usability, and easier readability. Conclusion/Significance: QFAT could be a suitable and user-friendly diagnostic alternative for use in the monitoring and surveillance of LF in field surveys based on its similar performance to FTS under field conditions. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work received financial support from the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD), which is funded at The Task Force for Global Health primarily by the Bill & Melinda Gates Foundation, by UK aid from the British government, and by the United States Agency for International Development through its Neglected Tropical Diseases Program. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approvals were obtained from the Samoa Ministry of Health and the Human Research Ethics Committee (HREC) of The University of Queensland (protocol 2021/HE000895), and the Australian National University HREC provided recognition of approval by another HREC. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. All data produced has also been lodged with the Task Force for Global Health, and summary data will be available on request if approved by the Samoa Ministry of Health.
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