Development of an Integrated Laboratory Diagnostics Software Platform for Rapid Infectious Disease Phenotyping

The client faces difficulties in integrating laboratory hardware, interfacing with existing Laboratory Information Systems (LIS), and providing comprehensive, real-time analysis and interpretation of complex diagnostic data. This hampers rapid turnaround times, accuracy of antibiotic susceptibility testing, and effective communication with healthcare providers, thereby impacting patient care quality and public health outcomes.

A mid-sized biotech or diagnostic laboratory company focused on infectious disease testing and personalized treatment support, seeking to enhance operational efficiency and result accuracy through advanced software solutions.

• Implement a unified software platform that seamlessly interfaces with laboratory hardware, LIS, and databases to streamline specimen processing workflows.
• Develop guided sample preparation interfaces to improve technician accuracy and consistency.
• Incorporate machine learning algorithms to analyze raw measurement data and generate clinically relevant antibiotic susceptibility results.
• Enable comprehensive review and troubleshooting tools for complex and failed test results.
• Ensure compliance with healthcare regulations such as FDA standards, facilitating results export and reporting.
• Improve laboratory throughput and data accuracy, reducing result turnaround times and enhancing diagnostic confidence.

• Interface to laboratory hardware instruments such as separators, inoculators, analyzers for real-time communication and data exchange.
• Integration with Laboratory Information Systems (LIS) for receiving orders and transmitting test results.
• Guided, step-by-step sample preparation interface with visual aids to assist technicians.
• Data collection and transmission from laboratory instruments to centralized software platform.
• Machine learning infrastructure to analyze raw data and determine Minimum Inhibitory Concentrations (MICs).
• Automated interpretation of MIC results based on regulatory guidelines for susceptibility or resistance.
• Web-based user interface for result review, troubleshooting of failed tests, and report generation.
• Export functionality for PDF reports compatible with healthcare documentation standards.
• Administrative tools for system configuration, user management, and data backup.

• Laboratory Instruments (Separators, Analyzers, Inoculators) for real-time data transmission
• Laboratory Information Systems (LIS) for receiving orders and sending results
• Healthcare regulatory systems for compliance validation
• Data storage and backup solutions

• System must support concurrent users with at least 99.9% uptime
• Data processing latency should not exceed 2 minutes for analysis results
• Ensure compliance with healthcare security standards such as HIPAA and FDA regulations
• Scalable architecture to support future increases in data volume and device integrations
• Automated testing and quality assurance protocols for high software reliability

This project aims to significantly reduce turnaround times for antibiotic susceptibility test results, improve the accuracy and consistency of data interpretation through machine learning, and enhance laboratory workflow efficiency. Ultimately, these improvements should lead to faster patient treatment decisions, better infection control, and support public health initiatives by providing high-quality, automated diagnostic reporting.