Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica

BackgroundThe neglected zoonosis, schistosomiasis japonica, remains a major public health problem in the Philippines. The current study aims to develop a novel gold immunochromatographic assay (GICA) and evaluate its performance in the detection of Schistosoma japonicum infection.MethodsA GICA strip...

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Main Authors: Yi Mu, Donald P. McManus, Catherine A. Gordon, Hong You, Allen G. Ross, Remigio M. Olveda, Pengfei Cai
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-04-01
Series:Frontiers in Immunology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2023.1165480/full
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author Yi Mu
Donald P. McManus
Catherine A. Gordon
Hong You
Allen G. Ross
Remigio M. Olveda
Pengfei Cai
author_facet Yi Mu
Donald P. McManus
Catherine A. Gordon
Hong You
Allen G. Ross
Remigio M. Olveda
Pengfei Cai
author_sort Yi Mu
collection DOAJ
description BackgroundThe neglected zoonosis, schistosomiasis japonica, remains a major public health problem in the Philippines. The current study aims to develop a novel gold immunochromatographic assay (GICA) and evaluate its performance in the detection of Schistosoma japonicum infection.MethodsA GICA strip incorporating a S. japonicum saposin protein, SjSAP4 was developed. For each GICA strip test, diluted serum sample (50 µl) was loaded and strips were scanned after 10 min to convert the results into images. ImageJ was used to calculate an R value, which was defined as the signal intensity of the test line divided by the signal intensity of the control line within the cassette. After determination of optimal serum dilution and diluent, the GICA assay was evaluated with sera collected from non-endemic controls (n = 20) and individuals living in schistosomiasis-endemic areas of the Philippines (n = 60), including 40 Kato Katz (KK)-positive participants and 20 subjects confirmed as KK-negative and faecal droplet digital PCR assay (F_ddPCR)-negative at a dilution of 1:20. An ELISA assay evaluating IgG levels against SjSAP4 was also performed on the same panel of sera.ResultsPhosphate-buffered saline (PBS) and 0.9% NaCl were determined as optimal dilution buffer for the GICA assay. The strips tested with serial dilutions of a pooled serum sample from KK-positive individuals (n = 3) suggested that a relatively wide range of dilutions (from 1:10 to 1:320) can be applied for the test. Using the non-endemic donors as controls, the GICA strip showed a sensitivity of 95.0% and absolute specificity; while using the KK-negative and F_ddPCR-negative subjects as controls, the immunochromatographic assay had a sensitivity of 85.0% and a specificity of 80.0%. The SjSAP4-incorperated GICA displayed a high concordance with the SjSAP4-ELISA assay.ConclusionsThe developed GICA assay exhibited a similar diagnostic performance with that of the SjSAP4-ELISA assay, yet the former can be performed by local personnel with minimal training with no requirement for specialised equipment. The GICA assay established here represents a rapid, easy-to-use, accurate and field-friendly diagnostic tool for the on-site surveillance/screening of S. japonicum infection.
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spelling doaj.art-802f5e1ef6da4fe58d5096a0843365672023-04-03T05:27:47ZengFrontiers Media S.A.Frontiers in Immunology1664-32242023-04-011410.3389/fimmu.2023.11654801165480Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonicaYi Mu0Donald P. McManus1Catherine A. Gordon2Hong You3Allen G. Ross4Remigio M. Olveda5Pengfei Cai6Molecular Parasitology Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, QLD, AustraliaMolecular Parasitology Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, QLD, AustraliaMolecular Parasitology Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, QLD, AustraliaMolecular Parasitology Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, QLD, AustraliaRural Health and Medical Research Institute, Charles Sturt University, Orange, NSW, AustraliaDepartment of Immunology, Research Institute for Tropical Medicine, Manila, PhilippinesMolecular Parasitology Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, QLD, AustraliaBackgroundThe neglected zoonosis, schistosomiasis japonica, remains a major public health problem in the Philippines. The current study aims to develop a novel gold immunochromatographic assay (GICA) and evaluate its performance in the detection of Schistosoma japonicum infection.MethodsA GICA strip incorporating a S. japonicum saposin protein, SjSAP4 was developed. For each GICA strip test, diluted serum sample (50 µl) was loaded and strips were scanned after 10 min to convert the results into images. ImageJ was used to calculate an R value, which was defined as the signal intensity of the test line divided by the signal intensity of the control line within the cassette. After determination of optimal serum dilution and diluent, the GICA assay was evaluated with sera collected from non-endemic controls (n = 20) and individuals living in schistosomiasis-endemic areas of the Philippines (n = 60), including 40 Kato Katz (KK)-positive participants and 20 subjects confirmed as KK-negative and faecal droplet digital PCR assay (F_ddPCR)-negative at a dilution of 1:20. An ELISA assay evaluating IgG levels against SjSAP4 was also performed on the same panel of sera.ResultsPhosphate-buffered saline (PBS) and 0.9% NaCl were determined as optimal dilution buffer for the GICA assay. The strips tested with serial dilutions of a pooled serum sample from KK-positive individuals (n = 3) suggested that a relatively wide range of dilutions (from 1:10 to 1:320) can be applied for the test. Using the non-endemic donors as controls, the GICA strip showed a sensitivity of 95.0% and absolute specificity; while using the KK-negative and F_ddPCR-negative subjects as controls, the immunochromatographic assay had a sensitivity of 85.0% and a specificity of 80.0%. The SjSAP4-incorperated GICA displayed a high concordance with the SjSAP4-ELISA assay.ConclusionsThe developed GICA assay exhibited a similar diagnostic performance with that of the SjSAP4-ELISA assay, yet the former can be performed by local personnel with minimal training with no requirement for specialised equipment. The GICA assay established here represents a rapid, easy-to-use, accurate and field-friendly diagnostic tool for the on-site surveillance/screening of S. japonicum infection.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1165480/fullschistosomiasisSchistosoma japonicumGICA striplateral flow immunochromatographic testELISArapid diagnosis
spellingShingle Yi Mu
Donald P. McManus
Catherine A. Gordon
Hong You
Allen G. Ross
Remigio M. Olveda
Pengfei Cai
Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
Frontiers in Immunology
schistosomiasis
Schistosoma japonicum
GICA strip
lateral flow immunochromatographic test
ELISA
rapid diagnosis
title Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
title_full Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
title_fullStr Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
title_full_unstemmed Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
title_short Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
title_sort development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica
topic schistosomiasis
Schistosoma japonicum
GICA strip
lateral flow immunochromatographic test
ELISA
rapid diagnosis
url https://www.frontiersin.org/articles/10.3389/fimmu.2023.1165480/full
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