Performance evaluation of the AiDx multi-diagnostic automated microscope for the detection of schistosomiasis in Abuja, Nigeria

In this research, we report on the performance of automated optical digital detection and quantification of Schistosoma haematobium provided by AiDx NTDx multi-diagnostic Assist microscope. Our study was community-based, and a convenient sampling method was used in 17 communities in Abuja Nigeria, based on the disease prevalence information extracted from the baseline database on schistosomiasis, NTD Division, of the Federal Ministry of Health. At baseline, samples from 869 participants were evaluated of which 358 (34.1%) tested S. haematobium positive by the reference diagnostic standard. Registered images from the fully automated (autofocusing, scanning, image registration and processing, AI image analysis and automatic parasite count) AiDx assist microscope were analyzed. The Semi automated (autofocusing, scanning, image registration & processing and manual parasite count) and the fully automated AiDx Assist showed comparable sensitivities and specificities of [90.3%, 98%] and [89%, 99%] respectively. Overall, estimated egg counts of the semi-automated & fully automated AiDx Assist correlated significantly with the egg counts of conventional microscopy (r = 0.93, p ≤ 0.001 and r = 0.89, p ≤ 0.001 respectively). The AiDx Assist device performance is consistent with requirement of the World Health Organization diagnostic target product profile for monitoring, evaluation, and surveillance of Schistosomiasis elimination Programs.Design for SustainabilityTeam Michel Verhaege

Image-Based Awareness Campaign and Community Mobilization in the Control of Schistosomiasis

Community awareness and participation in mass screening is critical for schistosomiasis control. This study assessed the impact of sharing anonymized image-based positive test results on the uptake of screening during community mobilization outreach. We conducted an observational study to compare the population response to standard and image-based strategies in 14 communitiesin Abuja, Nigeria. Six hundred and ninety-one (341 females, 350 males) individuals participated in this study. We analyzed the response ratio, relative increase, and sample collection time. The potential treatment uptake and change in social behavior were determined based on a semi-structured questionnaire. The mean response ratio of the image-based strategy was 89.7% representing asignificantly higher ratio than the 27.8%, which was observed under the standard mobilization approach (p ≤ 0.001). The image-based method was associated with 100% of the participants agreeing to provide urine samples, 94% willing to be treated, 89% claiming to have been invited to participate in the study by a friend, and 91% desiring to change a predisposing behavioral habit. These findings indicate that image-based community awareness campaigns may increase the population’s perception about schistosomiasis transmission and treatment. This raises new possibilities for local resource mobilization to expand services in reaching the last mile in schistosomiasis control.Design for Sustainabilit

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics