"A flexible and innovative connectivity solution to support national decentralised infectious diseases point-of-care testing programs in primary health services in Australia" (Preprint)

BACKGROUND Molecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralised POC testing program for STIs since 2016 and SARS-CoV2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users,a new system needed to be established. OBJECTIVE To design, implement, and optimise a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. METHODS We utilised commercially available e-messaging technology coupled with adapted proprietary software to integrate decentralised molecular POC testing platforms (GeneXpert) into geographically remote primary health services, and interface with end-user databases. This connectivity infrastructure was designed to overcome key barriers to implementation, integration, and monitoring of these large multi-jurisdictional decentralised infectious disease POC testing networks. Test results messages were tailored to meet end-user needs and system requirements. Using centrally captured deidentified program data, we evaluated time to receipt of test result by program, year and test type, and completeness of accompanying demographic data. RESULTS From January 2016 to April 2020, we operationalised the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems (PMS) to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (PMS, local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of result was 3.2 (IQR; 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimised the system to support rapid scale up of SARS-CoV2 testing (105 services; 6 jurisdictions; 71,823 tests) and additional STI testing (16,232 tests), including the introduction of electronic disease specific notifications to jurisdictional departments of health, and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered, with an overall median transmission time of 2.3 hours (IQR; 1.4-3.1): 2.2 hours for SARS-CoV-2 (n=16,066); 3.0 hours for CT/NG (n=1,843) and 2.6 hours for TV (n=1,446). Demographic data (age, sex and ethnicity) were complete for > 99% of test results in 2022. CONCLUSIONS This innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible and scalable. It represents the first such system in Australia, established independent of traditional pathology providers, capable of supporting decentralised infectious diseases POC testing across a network of geographically dispersed remote primary health services. The system has been optimised to deliver real-time test results to a range of end users and has proven critical for clinical, public health, and quality management requirements and data analysis. The system has significantly supported the equitable access to rapid diagnostics for infectious diseases across Australia and its design is suitable for onboarding other POC tests and testing platforms in the future.