Assay Configuration Software Separation for Protocol Customization
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Solution Overview
Problem
Existing assay devices face challenges in developing new or modified assays due to the integration of software and hardware, which requires extensive re-validation and limits user ability to create customized protocols and reports, thereby increasing costs and delaying market entry.
Innovation Solution
The separation of assay device software from assay configuration software allows for the creation and importation of assay protocols that specify sample preparation, thermal steps, signal processing, and reporting, enabling users to generate new or modified assays without extensive re-validation of the device's software and hardware.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If assay device software is integrated with hardware, then device control and operation are simplified, but any changes to assay protocols require extensive re-validation of the software and hardware
Solution Approach 1:
The patent segments the assay device into two independent components: device control software that manages hardware operations, and assay configuration software that defines assay protocols. This separation allows assay protocols to be modified without requiring re-validation of the device control software, thus resolving the contradiction between integration simplicity and customization flexibility.
Solution Approach 2:
The patent extracts the assay configuration functionality from the integrated device software into a separate, independent configuration system. This extracted configuration software can be developed, modified, and validated independently from the device control software, enabling assay protocol changes without extensive device re-validation.
2Reliability
If extensive re-validation is required for software changes, then device reliability is maintained, but time to market for new assays increases
Solution Approach 1:
By segmenting the software into device control and assay configuration components, the patent enables independent validation of each component. Changes to assay protocols only require validation of the configuration software, not the entire device system, thus reducing time to market while maintaining reliability through targeted validation.
Solution Approach 2:
The patent implements preliminary validation of the device control software during initial device certification. This preliminary action establishes a validated baseline that remains unchanged, allowing future assay protocol changes to be validated independently without repeating full device validation, thereby reducing time to market.
3Ease of operation
If users have limited ability to create customized assays, then device operation is simplified, but user flexibility and utility are reduced
Solution Approach 1:
The patent introduces an intermediary configuration software layer between the user and the device hardware. This intermediary provides user-friendly tools for creating and customizing assay protocols without requiring users to modify device control software, thus maintaining ease of operation while enabling extensive customization capabilities.
Solution Approach 2:
The patent enables users to independently create and customize assay protocols using the configuration software without requiring device manufacturer intervention or complex software modifications. Users can self-service their assay development needs while the device control software remains unchanged and validated.
Data Source
AI summary
Techniques are disclosed relating to assay configuration. Assay devices are often used to determine characteristics of test samples, e.g., using polymerase chain reaction (PCR) or Deoxyribonucleic Acid (DNA) melt techniques. Various disclosed techniques allow detailed specification of assay parameters. This may allow user modification of assays and/or assay development by third parties. In embodiments in which assay parameters are specified using a separate device, these techniques may reduce validation requirements resulting from modified assays. In some embodiments, assay configuration information that may be added/removed/modified may include: a sequence of operations, parameters for the sequence of operations, data processing parameters, call logic rules/dependencies, and/or reporting rules.