SchisCCA (INA-105) : Validation of the Schistosomiasis Point-of-Care Circulating Cathodic Antigen {POC-CCA} Rapid Urine Test for Qualitative Detection of Schistosoma japonicum

ClinicalTrials.gov: NCT03870204
Collaborator: NIAID, NIH
Status: Completed

https://clinicaltrials.gov/study/NCT03870204

The SchisCCA longitudinal cohort study was conducted in Napu Valley, Central Sulawesi, between September 2019 and February 2020 in coordination with the 2019 national schistosomiasis stool survey and mass drug administration campaign. Data from the 2018 and 2019 surveys informed the targeted enrollment of 185 participants (124 adults, 61 children) who had a history of infection with S. japonicum. Demographic information, clinical data, urine, and three consecutive stool specimens were collected from each participant after enrollment. Urine was used in a point of care schistosomiasis diagnostic test (POC-CCA) to evaluate sensitivity and specificity against gold standard Kato-Katz stool microscopy and centralized stool qPCR testing. Participants who were positive for schistosomiasis received standard treatment at a follow-up visit and provided an additional set of three stool specimens after 8 weeks to observe instances of reinfection. Microscopy revealed an infection prevalence of 19.4%, which was much lower than qPCR (44.0%) and POC-CCA (43.4% or 73.1%, depending on the strictness of test interpretation). The POC-CCA test had the lowest accuracy and consistently overestimated infection prevalence.

SchisCCA table
SchisCCA SITES Ver 2 (1)

Associated Biorepository

Testing type Baseline Follow up
(Visit 3/Post-Treatment)
Positive Negative Positive Negative
Stool PCR 81 102 15 28
Stool Kato Katz 29 156 26 18
Specimen type Baseline Follow up
(Visit 3/Post-Treatment)
Stool DNA extraction 185 44