SCORE Five Country CCA Evaluation Cross-sectional

Related studies:

SCORE Rwanda Mapping Cross-sectional
SCORE Burundi Mapping Cross-sectional

Background: Schistosomiasis is a parasitic disease caused by infection with blood flukes of the genus Schistosoma. An estimated 800 million people are at risk of infection and more than 200 million people are infected globally.

The standard test for S. mansoni involves duplicate Kato-Katz thick smear examination (two slides of a single stool specimen) from school-age children to estimate local infection prevalence and to map areas for MDA intervention. While essentially 100% specific, the Kato-Katz method has several limitations, including lack of sensitivity in areas of low prevalence and intensity, inconvenience of collecting stool samples, and the need for microscopy equipment and highly trained technicians. As an alternative to the stool exam, a new point-of-care (POC) lateral flow cassette assay that diagnoses Schistosoma mansoni infection by detection of parasite circulating cathodic antigen (CCA) in patient urine is commercially available, known to be reliable and effective, and could potentially replace traditional Kato-Katz stool examination for the mapping of areas at risk for intestinal schistosomiasis.

Objectives: To evaluate the utility of the POC-CCA assay, the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) funded investigators in five African countries for a harmonized multi-center evaluation of this POC-CCA assay's performance among school-age children in areas anticipated to have high, medium, or low prevalence and intensity of S. mansoni infection. Targeted study areas also included some areas with mixed S. mansoni and S. haematobium infection. For further comparison, school-age children were also tested from an area in Ethiopia that was endemic for soil-transmitted helminths (STHs), but believed to be non-endemic for S. mansoni.

Methodology:

Study Sites: Cameroon, Côte d'Ivoire, Ethiopia, Kenya, Uganda

Dates of Data Collection: 2012

Study Design: Cross-sectional survey

Data Collection: In the selected villages, investigators tested as many 9- to 12-year-old children as possible in local school classes. A total of 4,305 children from 63 schools in areas endemic for schistosomiasis in the five countries were tested. During the course of repeated daily visits, investigators collected one to three separate urine and stool specimens from each child on three consecutive days. The exception was in Uganda, where only one urine specimen was collected per child. All stools were tested using a standard quantitative Kato-Katz microscopic technique. POC-CCA tests were performed on the urine samples.

ClinEpiDB Data Integration: Data files were provided to ClinEpiDB as cleaned .csv files with all personal identifiers removed. All dates were obfuscated per individual through the application of a random number algorithm that shifted dates no more than seven days to comply with the ethical conduct of human subjects research.

Acknowledgements: We acknowledge all the laboratory and field staff in each of the collaborating countries, as well as their colleagues who formed the SCORE POC-CCA teams and the valuable cooperation of the district education and health bureaus, school directors and teachers, parents/guardians and participating school children.

Financial Support: SCORE is funded by the Bill & Melinda Gates Foundation through a grant to the University of Georgia Research Foundation (UGARF).

Ethics Statement: Ethical clearance for this study was obtained from the Human Subject's Office of the University of Georgia, the National Ethics Committee of Cameroon (no. 084/CNE/DNM/09), the institutional research commission of the Swiss Tropical and Public Health Institute (Basel, Switzerland), the ethics committees of Basel (EKBB; reference no. 377/09), and of Cote d'Ivoire (reference no. 1993426 MSHP/CNER), the National Council for Science and Technology of Uganda, the Institutional Review Board of Aklilu Lemma Institute of Pathobiology, Addis Ababa University of Ethiopia, and the National Ethics Review Committee of the Kenya Medical Research Institute (KEMRI-SSC no. 1768).

Last Updated: March 5, 2021The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) supported the evaluation of a commercial point-of-care circulating cathodic antigen (POC-CCA) test for assessing Schistosoma mansoni infection prevalence in areas at risk in 5 countries- Cameroon, Côte d'Ivoire, Ethiopia, Kenya, and Uganda. The study concluded that one urine POC-CCA test can replace Kato-Katz testing for community-level S. mansoni prevalence mapping.