TY - JOUR
T1 - Diagnostic performance of a urine-based ELISA assay for the screening of human schistosomiasis japonica
T2 - A comparative study
AU - Mu, Yi
AU - Weerakoon, Kosala G.
AU - Olveda, Remigio M.
AU - Ross, Allen G.
AU - McManus, Donald P.
AU - Cai, Pengfei
N1 - Funding Information:
This research was funded by the National Health and Medical Research Council (NHMRC) of Australia (ID: APP1160046, APP2008433, APP1098244, APP1102926, and APP1037304). DM is a NHMRC Leadership Fellow and Distinguished Scientist at QIMRB. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
Copyright © 2022 Mu, Weerakoon, Olveda, Ross, McManus and Cai.
PY - 2022/11/14
Y1 - 2022/11/14
N2 - The current study developed and evaluated the performance of a
urine-based enzyme-linked immunosorbent assay (ELISA) for the screening
of Schistosoma japonicum infection in a human cohort (n
= 412) recruited from endemic areas, Northern Samar, the Philippines.
The diagnostic performance of the urine ELISA assay was further compared
with the Kato-Katz (KK) technique, serum-based ELISA assays,
point-of-care circulating cathodic antigen (POC-CCA) urine cassette
test, and droplet digital (dd)PCR assays performed on feces, serum,
urine, and saliva samples, which were designated as F_ddPCR, SR_ddPCR,
U_ddPCR, and SL_ddPCR, respectively. When urine samples concentrated 16×
were assessed, the SjSAP4 + Sj23-LHD-ELISA (U) showed
sensitivity/specificity values of 47.2/93.8% for the detection of S. japonicum infection in KK-positive individuals (n = 108). The prevalence of S. japonicum
infection in the total cohort determined by the urine ELISA assay was
48.8%, which was lower than that obtained with the F_ddPCR (74.5%, p < 0.001), SR_ddPCR (67.2%, p < 0.001), and SjSAP4 + Sj23-LHD-ELISA (S) (66.0%, p < 0.001), but higher than that determined by the Sj23-LHD-ELISA (S) (24.5%, p < 0.001), POC-CCA assay (12.4%, p < 0.001), and SL_ddPCR (25.5%, p
< 0.001). Using the other diagnostic tests as a reference, the urine
ELISA assay showed a sensitivity between 47.2 and 56.9%, a specificity
between 50.7 and 55.2%, and an accuracy between 49.3 and 53.4%. The
concentrated urine SjSAP4 + Sj23-LHD-ELISA developed in the current
study was more sensitive than both the KK test and POC-CCA assay, and
showed a comparable level of diagnostic accuracy to that of the U_ddPCR.
However, its diagnostic performance was less robust than that of the
F_ddPCR, SR_ddPCR, and SjSAP4 + Sj23-LHD-ELISA (S) assays. Although they
are convenient and involve a highly acceptable non-invasive procedure
for clinical sample collection, the insufficient sensitivity of the
three urine-based assays (the urine ELISA assay, the U_ddPCR test, and
the POC-CCA assay) will limit their value for the routine screening of
schistosomiasis japonica in the post mass drug administration (MDA) era,
where low-intensity infections are predominant in many endemic areas.
AB - The current study developed and evaluated the performance of a
urine-based enzyme-linked immunosorbent assay (ELISA) for the screening
of Schistosoma japonicum infection in a human cohort (n
= 412) recruited from endemic areas, Northern Samar, the Philippines.
The diagnostic performance of the urine ELISA assay was further compared
with the Kato-Katz (KK) technique, serum-based ELISA assays,
point-of-care circulating cathodic antigen (POC-CCA) urine cassette
test, and droplet digital (dd)PCR assays performed on feces, serum,
urine, and saliva samples, which were designated as F_ddPCR, SR_ddPCR,
U_ddPCR, and SL_ddPCR, respectively. When urine samples concentrated 16×
were assessed, the SjSAP4 + Sj23-LHD-ELISA (U) showed
sensitivity/specificity values of 47.2/93.8% for the detection of S. japonicum infection in KK-positive individuals (n = 108). The prevalence of S. japonicum
infection in the total cohort determined by the urine ELISA assay was
48.8%, which was lower than that obtained with the F_ddPCR (74.5%, p < 0.001), SR_ddPCR (67.2%, p < 0.001), and SjSAP4 + Sj23-LHD-ELISA (S) (66.0%, p < 0.001), but higher than that determined by the Sj23-LHD-ELISA (S) (24.5%, p < 0.001), POC-CCA assay (12.4%, p < 0.001), and SL_ddPCR (25.5%, p
< 0.001). Using the other diagnostic tests as a reference, the urine
ELISA assay showed a sensitivity between 47.2 and 56.9%, a specificity
between 50.7 and 55.2%, and an accuracy between 49.3 and 53.4%. The
concentrated urine SjSAP4 + Sj23-LHD-ELISA developed in the current
study was more sensitive than both the KK test and POC-CCA assay, and
showed a comparable level of diagnostic accuracy to that of the U_ddPCR.
However, its diagnostic performance was less robust than that of the
F_ddPCR, SR_ddPCR, and SjSAP4 + Sj23-LHD-ELISA (S) assays. Although they
are convenient and involve a highly acceptable non-invasive procedure
for clinical sample collection, the insufficient sensitivity of the
three urine-based assays (the urine ELISA assay, the U_ddPCR test, and
the POC-CCA assay) will limit their value for the routine screening of
schistosomiasis japonica in the post mass drug administration (MDA) era,
where low-intensity infections are predominant in many endemic areas.
KW - diagnosis
KW - droplet digital PCR
KW - ELISA
KW - POC-CCA
KW - Schistosoma japonicum
KW - schistosomiasis
KW - urine
UR - http://www.scopus.com/inward/record.url?scp=85142839465&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85142839465&partnerID=8YFLogxK
U2 - 10.3389/fmicb.2022.1051575
DO - 10.3389/fmicb.2022.1051575
M3 - Article
C2 - 36452928
AN - SCOPUS:85142839465
SN - 1664-302X
VL - 13
JO - Frontiers in Microbiology
JF - Frontiers in Microbiology
M1 - 1051575
ER -
