Pooled Sputum Sample Testing for SARS-CoV-2
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Solution Overview
Problem
Current laboratory-based RT-PCR testing for SARS-CoV-2 is time-consuming and requires centralized facilities, leading to prolonged turnaround times, while point-of-care tests lack efficiency in handling multiple samples effectively.
Innovation Solution
A method involving the collection and pooling of sputum samples using an absorbent device, followed by analysis using a device capable of amplifying nucleic acid sequences, allowing for rapid detection of SARS-CoV-2 at the point of care without the need for laboratory facilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If pooled samples are tested using conventional laboratory RT-PCR, then testing throughput is improved, but turnaround time increases due to batch processing and transportation requirements
Solution Approach 1:
The invention divides the testing process into two distinct stages: a rapid pooled screening stage that processes multiple samples simultaneously, and a confirmatory individual testing stage. This segmentation allows high-throughput screening without compromising individual result accuracy, resolving the contradiction between testing throughput and turnaround time by handling different sample groups through different processing pathways.
Solution Approach 2:
The method performs preliminary pooled testing before individual confirmatory testing. By conducting the pooled screening first, the system identifies potential positives efficiently, allowing only those specific cases to undergo time-consuming individual testing. This preliminary action maximizes throughput while minimizing the time loss associated with comprehensive individual testing of all samples.
2Productivity
If pooled samples are tested, then resource utilization is improved, but sensitivity may decrease due to sample dilution
Solution Approach 1:
The invention adjusts the pooling ratio parameters to optimize both resource utilization and detection sensitivity. By carefully controlling the number of samples per pool and the volume of each sample contributed to the pool, the method maintains sufficient analyte concentration for reliable detection while achieving efficient resource utilization through pooled processing.
Solution Approach 2:
The system incorporates feedback mechanisms where pooled test results inform subsequent individual testing decisions. When a pooled sample tests positive, feedback triggers targeted individual confirmatory testing for all samples in that pool. This feedback loop ensures that resource utilization through pooling does not compromise sensitivity, as any potential false negatives are caught and verified through individual testing of positive pools.
3Measurement precision
If individual samples are tested separately, then detection accuracy is maintained, but testing efficiency decreases
Solution Approach 1:
The testing workflow is segmented into two distinct phases: pooled screening phase for efficiency and individual confirmatory testing phase for accuracy. This segmentation allows the system to achieve high testing efficiency through pooled processing while maintaining detection accuracy through subsequent individual testing of positive cases, thereby resolving the contradiction between these two parameters.
Solution Approach 2:
Instead of performing complete individual testing on all samples (excessive action), the method applies partial testing through pooled screening first. Only the subset of samples that test positive in the pooled phase undergo individual confirmatory testing. This partial action approach maintains detection accuracy for all potentially positive cases while significantly improving overall testing efficiency by avoiding redundant individual testing of clearly negative samples.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach significantly reduces turnaround time, increases testing throughput, and enables timely clinical decision-making by providing rapid results, while maintaining high sensitivity and specificity, even with larger sample pools.
Implementation Method 1
the device comprising an absorbent material for absorbing at least some of the portion of each sample in order to form a pooled sample absorbed to the absorbent material of the device
Implementation Method 2
an analyser capable of amplifying, if present in the pooled sample, one or more nucleic acid sequences associated with the disease or condition
Data Source
AI summary
The present invention relates to the use of pooled samples to optimise the efficiency and utility of a rapid, lab-free point-of-care test. It is applicable in particular, though not necessarily, to tests for SARS-CoV-2.