Urine congophilia dipstick test for preeclampsia screening in resource limited settings

Urine congophilia dipstick test for preeclampsia screening in resource limited settings

Nidhya N Joghee , Nivedha N Joghee
Healthcare Technology Innovation Centre (HTIC), IIT Madras, Chennai, India; Coimbatore Medical College and Hospital, Tamil Nadu, India

Need of an innovation: Performance limitations exist with current screening tools (blood pressure and proteinuria dipstick) for preeclampsia (PE) in low-resource settings leading to preventable mortality and morbidity. Biomarker based tests show promise in improving the diagnostic accuracy, but commercial diagnostics have cost and operational characteristics not amenable for widespread use in low-resource settings (LRS). The innovation is a PE biomarker-based urine dipstick test with product characteristics aligned with WHO ASSURED criteria (Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Equipment-free and Deliverable to end users). Urine Congophilia was selected as the PE biomarker after initial desk research on assessment of promising urine biomarkers for preeclampsia, considering the technical and commercial feasibilities. The test consists of a strip that has to be dipped in urine and enables a simple yes/no visual interpretation within 15 minutes. Urine congophilia has been previously reported to have better sensitivity, specificity and predictive value for preeclampsia and adverse outcomes, than blood pressure and proteinuria dipstick, about 10 weeks prior to clinical symptoms. The impacts of increased accessibility to affordable PE diagnostics to LRS include enabling timely clinical interventions, reduced adverse outcomes due to PE, reduced preventable hospital expenditures for patients and optimal use of hospital resources. The test could also be explored for potential use as doctor-prescribed home testing for PE monitoring.