Background
A diagnostics company was developing a rapid point-of-care assay for a target analyte, but the target’s low concentration in the relevant sample matrix fell below the detection limit of existing rapid-test chemistries.
The Challenge
It was unclear whether any combination of assay chemistry and sample preparation could achieve clinically useful sensitivity within the time and format constraints of a point-of-care test.
Technological Uncertainty
It was not known in advance whether the required sensitivity could be achieved without a laboratory-grade amplification step, or whether an alternative signal amplification approach compatible with a rapid point-of-care format existed for this analyte.
Experimental Development
The team systematically tested alternative signal amplification chemistries and sample preparation methods, measuring detection sensitivity, specificity, and time-to-result for each combination against reference samples.
What Failed?
An initial amplification chemistry improved sensitivity but extended assay time beyond the point-of-care target, and a subsequent faster chemistry introduced cross-reactivity issues that reduced specificity.
Technological Advancement
The team developed a modified amplification and detection approach that met both sensitivity and time-to-result targets while maintaining acceptable specificity, generating new assay-specific knowledge not available in published methods for this analyte and format.
Potentially Relevant SR&ED Activities
- Systematic testing of amplification chemistries against sensitivity and time targets
- Specificity testing and cross-reactivity investigation across formulations
- Assay validation against reference sample panels
What Would Generally Not Qualify
Manufacturing and running the finalized, validated assay in production would be routine and would not itself qualify as further eligible development.
Documentation
Sensitivity and specificity data across chemistry iterations, validation study records, and technical notes explaining why standard chemistries were insufficient would support this claim.
