Performance of the point-of-care circulating cathodic antigen test in the diagnosis of schistosomiasis japonica in a human cohort from Northern Samar, the Philippines

Background:Zoonotic schistosomiasis,caused by Schistosoma japonicum,remains a major public health problem in the Philippines.This study aimed to evaluate the commercially available rapid diagnostic point-of-care circulating cathodic antigen(POC-CCA)test in detecting individuals infected with S.japonicum in a human cohort from an endemic area for schistosomiasis japonica in the Philippines.Methods:Clinical samples were collectedin 18 barangays endemic for S.japonicum infection in Laoang and Palapag municipalities,Northern Samar,the Philippines,in 2015.The presence of CCA in flter-concentrated urine samples(n=412)was evaluated using the commercial kits and the results were converted to images,which were further analyzed by ImageJ software to calculate R values.The diagnostic performance of the immunochromatographic POCCCA test was compared using the Kato-Katz(KK)procedure,in-house enzyme-linked immunosorbent assays(ELISAs)and droplet digital(dd)PCR assays as reference.Results:The POC-CCA test was able to detect S.japonicum-infected individuals in the cohort with an eggs per gram of faeces(EPG)more than or equal to 10 with sensitivity/specifcity values of 63.3%/93.3%.However,the assay showed an inability to diagnose schistosomiasis japonica infections in all cohort KK-positive individuals,of which the majority had an extremely low egg burden(EPG:1–9).The prevalence of S.japonicum infection in the total cohort determined by the POC-CCA test was 12.4%,only half of that determined by the KK method(26.2%).When compared with the ELISAs and ddPCR assays as a reference,the POC-CCA assay was further shown to be a test with low sensitivity.Nevertheless,the assay exhibited signifcant positive correlations with egg burden determined by the KK technique and the target gene copy number index values determined by the ddPCR assays within the entire cohort.Conclusions:By using in silico image analysis,the POC-CCA cassette test could be converted to a quantitative assay to avoid reader-variability.Because of its low sensitivity,the commercially available POC-CCA assay had limited potential for determining the status of a S.japonicum infection in the target cohort.The assay should be applied with caution in populations where schistosome parasites(especially S.japonicum)are present at low infection intensity.