A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202009780096688

Enrollment

776

Registered

2020-09-16

Start date

2020-10-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis

Interventions

Rapid diagnostic test

Kato Katz and Urine Filtration microscopy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Individuals aged 5 years and above Residents of study areas for a period of at least 1 year Willingness to provide informed consent Willingness to provide stool, urine and blood samples

Exclusion criteria

Exclusion criteria: Individuals above 100 years of age or who feels/appears unwell Unable to provide a blood and one-day stool and urine sample Individual has taken praziquantel within the past 2 months

Design outcomes

Secondary

Measure	Time frame
Percentage agreement between finger prick and venous blood, and between finger prick and microscopy-based methods, and venous blood and microscopy-based methods; Stratification of the clinical sensitivity and specificity across three age groups (5-9, 10-15, >15 years old), across three levels of infection intensity (low, moderate and high), and for each sample type (venous blood and finger prick blood); Description of test operator experience with the CAA prototype RDT	—

Measure

Time frame

Percentage agreement between finger prick and venous blood, and between finger prick and microscopy-based methods, and venous blood and microscopy-based methods; Stratification of the clinical sensitivity and specificity across three age groups (5-9, 10-15, >15 years old), across three levels of infection intensity (low, moderate and high), and for each sample type (venous blood and finger prick blood); Description of test operator experience with the CAA prototype RDT

—

Primary

Measure	Time frame
Clinical sensitivity of the CAA prototype RDT in a schistosomiasis endemic area; Clinical specificity of the CAA prototype RDT in a schistosomiasis endemic area; Clinical specificity of the CAA prototype RDT in a schistosomiasis non-endemic area	—

Countries

Kenya

Contacts

Public ContactHenry Kanyi

Research Scientist

kanyi2009@gmail.com+254788922040

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026