Project Lead(s): Dhananjaya Dendukuri
Issue
Diarrhea is the second leading cause of death (1.5 million/year) worldwide in children under five years of age and rotavirus is the most common cause of severe diarrhea.
In low-income countries, where hygiene, awareness and availability of vaccines are limited, rapid and low-cost diagnosis of rotavirus is a major challenge.
Solution
The project team sought to develop fabric-based immunosensors that could be easily integrated into infant disposable diapers for the diagnosis of rotavirus in stool samples.
This non-intrusive, safe collection and rapid qualitative detection of rotavirus in a diaper could be done conveniently at home or in a doctor’s clinic.
The team successfully developed a fabric platform for the rotavirus test to work in two formats: a standard, lateral-flow format with all dried reagents and a lateral-flow format with wet conjugate.
Both formats were tested and evaluated with clinical samples; the second format reported better results.
The fabric-based rotavirus test was successfully evaluated using 58 positive and 16 negative stool samples from pediatric patients submitted for rotavirus testing at three sites.
Outcome
Test results showed 100% sensitivity and 93.75% specificity.
The limit of detection in the stool sample was found to be 3x105 viral particles.
For comparative analysis, specimens were also tested on the ‘Rotavirus Antigen Rapicard Insta Test’ from Cortez diagnostics and the ‘VIKIA Rota-Adeno test’ from Biomeriux.
Test results showed 100% agreement with commercial kits.
In laboratory settings, fabric chips have been integrated into diapers and tested successfully with clinical samples.
The team has received additional funding from PATH and private investor Catamaran to continue the project.