Feasibility and development of an automated HIV self-testing system

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PAR-17-471: Detection of HIV for Self-testing (R61/R33) Feasibility and development of an automated HIV self-testing system Abstract Diagnostics for the Real World Ltd (DRW) has developed and CE-marked its SAMBA II platform for sample-in result-out point of care (PoC) testing, with tests for HIV acute infection and vial load monitoring. SAMBA II uses pre-loaded, ready-to-use cartridges containing all required reagents, which can be shipped and stored at room temperature. SAMBA II is a fully automated, PoC testing system incorporating sample extraction, nucleic acid amplification, detection and interpretation of results. Results are automatically read and can be printed and sent via SMS messaging to a mobile phone or any cloud–based or secure database. DRW will exploit development and field experience from SAMBA II to develop an innovative system for HIV self-testing: SAMBA III. It will aim to be as easy to use as a pregnancy test or blood glucose test: a user will only need to collect a whole blood sample from a finger prick, add it to a device or cartridge to automatically process the sample and return a result. Development will involve chemistry and a device. The main aims of the chemistry development during the R61 phase will focus on reducing the assay time and simplifying the chemistry for automation with the current SAMBA chemistry as a starting point. Chemistry development will focus mainly on (1) improving the detection of Group O subtype; (2) simplification of nucleic acid extraction from whole blood; (3) simplification and reduction in time of the amplification/detection method. The chemistry will be processed in a new SAMBA III cartridge and device, the latter to supply temperature control, fluid handling and results reading. The project will be challenging and DRW will also pursue an alternative strategy of reductions of size, weight and cost to the current SAMBA II system to allow it to be used for self- testing. Overall direction and project management will be done by DRW in California along with the main chemistry development, quality, system testing, sample testing and regulatory management, including field performance evaluation. The current SAMBA II chemistry, cartridge and instrument were originally developed by personnel at DRW’s subsidiary in the UK, Diagnostics for the Real World (Europe) Limited, therefore a portion of the work proposed in this application will be done by DRW Europe in the UK. If the R61 Phase succeeds, DRW will continue with an R33 phase. The work for this phase will involve finalizing and optimizing the cartridge and device design, further develop manufacturing capabilities for the new system, evaluate test performance, including sensitivity, specificity and testing actual clinical samples and useability.