eLITE: electronic Laboratory Information to Everyone

eLITE empowers individuals and their healthcare providers to electronically order relevant laboratory services, receive their HIV/TB/COVID19/NCD laboratory test results, capture point-of-care test results, and keep track of their patient journey in health. eLITE centralizes secure laboratory data for national disease monitoring and improves quality services across Africa.

Wendy Stevens is Head of Department of Molecular Medicine and Haematology at the University of the Witwatersrand, Director of National Priority Program (National Health Laboratory Service) and Director of iLEAD.

Barriers to pathology and laboratory medicine, exacerbated within resource-limited settings (RLS), include access to affordable diagnostics, well-informed and supported healthcare practitioners, and limited infrastructure for optimal workflow and services in primary healthcare settings. COVID19 exposed these gaps and highlighted the need for point-of-care testing (POCT), rapid access to data and specimen self-collection/self-monitoring. Healthcare facilities remain paper-based and laboratory results are unavailable in real-time. Where LIS (laboratory information system) exist, they are expensive and have limited capability to extend beyond centralised laboratory networks.  While POCT can be available for faster in-clinic turn-around time, results are not captured to centralised databases. Lack of data integration hinders decision making at patient and programme levels.  Within the WHO African region, this impacts individuals requiring accurate diagnosis and regular ongoing treatment monitoring, such as those living with HIV (25.7million), diabetes (>20million) and hypertension (~200million), or those with tuberculosis (2.5million) or COVID19 (>3million to date). Innovations remain central to strengthening the pathology value chain and include new diagnostic tests, clinical and laboratory workflow reengineering, improved testing algorithms, alternative and less invasive specimens of improved quality, faster result delivery, improved access to results and overall improved service efficiencies within a tiered, networked laboratory system.

eLITE, leveraging eLABS’ system, aims to close healthcare gaps by linking stakeholders across the pathology value chain through data integration: (1) Patients will be empowered, using direct messaging, to respond to healthcare recommendations, promoting patient-centered care; (2) Healthcare providers will have decreased workloads (electronic result return, specimen self-collection and minimized clinic visits), integrated POCT and laboratory results, and complete and accessible patient records for improved patient management; (3) Specimen transport logistical data will inform courier routes and delivery schedules, in addition to monitoring the specimen from clinic-to-laboratory; (4) Laboratories will be better able to plan resources, identify gaps to improve quality of specimen integrity, testing and results, and provide POCT oversight; and (5) Decision-makers will have access to real-time, relevant and accurate data in the form of dashboards to inform decisions, emergency responses and policy. Ongoing support is available to all stakeholders through experienced technical advisors who provide ongoing training, site visits and remote assistance channels. Stakeholders are engaged regularly, particularly ahead of new module design, and the user experience (UX) surveys and forums continue to guide and inform system improvements. The system development road-map is endorsed through governance structures, including specialist advisory boards and product forums.

eLITE provides a new service, with the eLABS system already in use in real-world settings at country-level scale for monitoring the pathology value chain. While designed for Afrocentric settings,  eLITE strives towards increased universal healthcare (UHC) and improved patient care through optimized clinic-laboratory-patient interfaced workflows, resulting alerts and educational messages to stimulate the right action at the right time using a combination of digital devices and automated analytics of unique datasets. Rapid access to patient and program-level secure data, previously unavailable in electronic format or in real-time has immense public good through improved knowledge dissemination. More services are monitored, data is available sooner and more accessible through mobile devices and web-based portals. All leading to improved health outcomes, especially in resource limited settings.  Access to secure dashboards through a data command center of facility to program level data visualizes operations and alerts for action which previously was unavailable making this a high value solution for public sector healthcare.  In addition, Ministries of Health (MoH) and in-country stakeholders will benefit from overall improved pathology services through the provision of eLITE’s technical and implementation support (including rapid sites assessment, GIS mapping, route optimization, and assistance in streamlining resources). 

eLITE’s strategic goal is improving access to health services for high burden diseases (HIV, TB, COVID19 and NCD) through digital health technology. This can be achieved by strengthening communication across the pathology value chain, which will improve access to testing for the under-served patient and decrease HCP burden. This outcome will be achieved by introducing quality-monitored POCT, accessible specimen self-collection and patient self-monitoring through eLABS. 

These outputs will be achieved through specific activities: (i) modules developed (minimum viable product, training materials/aids suitable for ALL end users); (ii) introduction of modules in pilot settings (key engagements, stakeholder forums, evaluation studies); (iii) analysis of data (user experience, impact of novel modules, translational analytics) and (iv) implementation projects, with ongoing impact analysis. Incorporating these modules into the existing eLABS system, with proven monitoring of pre-analytic, analytic and post-analytic processes and existing databases, will allow data monitoring to assess impact. Expected impacts include improved and acknowledged result return to patients, decreased turnaround time (TAT), and decongested clinics (reduced HCP burden). Impact will also be assessed through user-experience surveys. These types of impact monitoring have already been shown through the eLABS specimen tracking and result return to HCP modules for HIV VL. 

Our targeted impacts are to achieve UNAIDS 95-95-95 HIV goals, reach the TB missing millions, ensure equitable screening for COVID19 and NCD, and remain agile to address future health threats. Impact will be scaled by expanding modular offerings from proof-of-concept to implementation within South Africa, followed by extending these offerings to countries already using eLABS, and finally, by year 3, based on success evidence, expanding to further RLS. Demonstration, pilot and implementation projects will continue in parallel to new offerings, strengthening the base for expansion and addressing gaps already available through eLABS. eLABS has already demonstrated impact by closing HIV treatment gaps (2.5million VL processed in Zambia/South Africa <3 years) and improving result quality, with rapid implementation of the COVID19 module (>400 000 tests) evidence of agile scalability. Persons beyond those living with HIV will be reached through the novel modules, improving other areas of healthcare. Using a patient-centered model will impact by enabling responsibility for one’s own health. Impact will be scaled through buy-in from MOH, sponsors supporting these settings (e.g. PEPFAR, Global Fund, CHAI) and public-private-partnerships. Scale-up will include sustainability approaches (training, mentorship, technical support) ensuring country ownership of the program. 

Impact is measured by assessing key performance indicators (KPI) against baseline. The rapid assessment tool allows swift overview of KPI status quo. KPI for successful program impact cover pre-analytic, analytic and post-analytic processes across the pathology value chain. These include specimen rejection rates, result TAT, percentage test coverage for affected populations, proportion of clinicians using the implemented systems, proportion of patients using patient support modules and number of patients reached by the implementation roll-out. Specific KPI (e.g. HIV suppression rate) are created per solution.

Each project has or will have a detailed monitoring and evaluation (M&E) plan guided by a comprehensive work plan, which will extend beyond year 3. A logic framework for each implementation will link activities to the intended KPI and a data management plan (DMP) that ensures continued quality improvement will be implemented. Progress will be monitored daily, weekly and monthly, with quarterly reports developed for feedback. 

Successful examples of existing M&E for eLABS include >90% HIV suppression rates, decreased TAT (>90 days to 23 days) and >90% results acknowledged in Zambia, >90% HIV VL results returned in <96 hours in South Africa, and <2% rejected rate (target of <5%) in both countries.

First year: Concern of data privacy and security legislation: Ministries of Health prefer in-country hosting of data. Through our experience of scaling eLABS in two countries in Africa, it has highlighted potential difficulties of in-country hosting and each national implementation requires country-specific key opinion leader engagements to navigate data hosting regulations. Country introduction will require hosting resolution discussions upfront, and a country-specific Data Sharing Agreement and hosting action plan to be implemented. Our group has also developed a digital health policy for South Africa, which can provide guidance to neighboring countries.  

Three years: POCT instrument integration with eLABS may present a challenge for some commercial suppliers. Forums will be established to ensure open dialogue with third party entities to encourage collaboration. South Africa’s MoH and national clinical and laboratory stakeholders recently endorsed a POCT policy, which sets the agenda for national deployment of POCT and thereby requirement for uptake and integration with middle-ware and LIS. Patient feasibility and acceptability for specimen-self collection: We have experience in HIV self-sampling and testing and recently in nasal swab self-collection for COVID19 diagnostics, however, facility infrastructure for uptake of self-sampling of urine and blood may not be feasible. This will require engaging policy makers. 

• Innovation: iLEAD (BMGF), Wits Faculty of Health Sciences
• Technology partner: Mezzanine (Vodafone subsidiary - Africa) 
• Laboratory Partner: NHLS Priority Programs (South Africa)
• Clinical Implementation: Right-to-Care, WRHI, Ezintsha, Wits Vida, SEAD
• Support partners: CDC, USAID, EQUIP, Global Fund
• Cost modelling/route mapping: HE2RO (Boston University), CHAI
• Finance/legal: Wits Health Consortium

eLITE has a mature data driven innovation, eLABS, that addresses gaps in the pathology value chain. Successful uptake and interest in five countries is testament to its ongoing need and usefulness for patient care and program monitoring to help countries achieve health targets for priority diseases. Growing eLABS to expand test repertoires beyond HIV and COVID19 testing, integrate with POCT and encompass self-collection/self-monitoring will require collaboration with diagnostic suppliers. Trinity members such as BMGF, Imperial College and Microsoft are well poised to assist with introductions to and facilitate discussions with early-phase product developers and non-flexible commercial entities, which may be suitable matches to eLABS. 

Sustainability of eLITE’s program beyond current donor-funded support will require strong marketing and a business model suitable for African environments, and exploring commercialization and diversification into private healthcare and supply-chain monitoring (e.g. medicines, laboratory diagnostic consumables and reagents), which we feel Trinity members like CHAI may facilitate. 

Resources to conduct impactful and generalizable research are limited in RLS. Trinity  may enable demonstration and pilot of eLITE’s innovations, and Trinity members can assist with refining products and facilitating introductions to local governments and private sectors, thus stimulating further expansion in much needed RLS.

eLITE envisages partnering with Microsoft and/or Google to assist in increasing global access, provide mentorship to the eLITE technical team,  provide insights for potential streamlining digital processes, strengthening data security protocols and visual graphic design. 

Parenting with an independent entity like Discovery Health who are governed by the medical schemes act could strengthen eLITE’s inclusion of wearable devices interfacing with eLABS for patient-monitoring.  

eLITE sees real value in continuing their long-standing partnership with CHAI, to further leverage their costing and technical information expertise, and reach across the African continent. 

Continued partnership with BMGF and the on-boarding of Imperial College could greatly increase our access to diagnostic and other digital technology innovations for continued growth of eLITE and ensure relevance. 

This suggested multi-partner approach will synergise and streamline collaborations and  minimise duplication of efforts. 

As a not-for-profit organisation, eLITE depends on grant funding. Sponsors (USAID, CDC and BMGF) have provided the backbone to ongoing innovation development and implementation, which we would like to continue. This also includes ongoing stakeholder engagements with in-country Ministries of Health and implementing partners.