Single-Swab Sample Splitting for POC and Lab Testing
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Solution Overview
Problem
Current methods for point of care (POC) testing do not allow for both rapid testing and laboratory-based testing using the same sample, often resulting in sample dilution that diminishes test performance and requires additional sample collection, leading to potential errors and inefficiencies.
Innovation Solution
A method involving the collection of a sample for POC testing using a gentle lysis reagent, with a portion used for POC testing and the remaining portion combined with a stabilization transport diluent for laboratory testing, enabling both POC immunoassay and laboratory tests like PCR without significant sample dilution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If samples are diluted in liquid transport media for transfer to laboratory, then samples can be transported for lab-based testing, but sample dilution effects diminish rapid test performance
Solution Approach 1:
The sample processing is segmented into two distinct pathways: one portion of the processed sample is used for immediate POC rapid testing, while another portion is preserved in liquid transport media for subsequent laboratory-based testing. This segmentation allows each test type to receive appropriately concentrated samples without compromising the other.
Solution Approach 2:
The invention extracts a portion of the processed sample from the main sample pool after POC testing. By taking out a specific aliquot of the processed sample and placing it in liquid transport media, the system enables laboratory testing without requiring dilution of the original sample, thereby maintaining test performance.
2Adaptability or versatility
If a second swab is collected at POC site for laboratory testing, then laboratory-based testing can be performed, but the number of samples to be taken doubles and collection methods may lead to erroneous results
Solution Approach 1:
The single swab specimen serves multiple functions: it is used for both POC rapid testing and laboratory-based testing. By processing the sample once and then dividing it into two portions (one for POC, one for lab), the system eliminates the need for a second swab collection while maintaining both testing capabilities.
Solution Approach 2:
The invention merges the sample collection step for both POC and laboratory testing into a single swab collection event. The single collected sample is then processed and split, combining the benefits of both test types without requiring separate collection procedures, thereby reducing the total number of samples needed.
3Productivity
If the portion of processed sample not used in rapid test is discarded, then rapid test can be performed, but opportunity to perform lab-based testing is lost
Solution Approach 1:
Instead of discarding the portion of processed sample not used in rapid testing, the invention recovers this material by transferring it to liquid transport media. This recovered sample portion can then be used for laboratory-based confirmatory or reflex testing, maximizing the utility of the original sample collection.
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 allows for effective POC testing while preserving the sample for laboratory confirmation or subtyping, maintaining nucleic acid integrity and enabling accurate PCR results, even with extended storage and transport, thus enhancing clinical performance and reducing the need for additional sample collection.
Implementation Method 1
combining the collected sample with a POC processing reagent configured for use with a POC test, wherein the POC processing reagent consists essentially of a gentle lysis reagent
Implementation Method 2
the remaining portion combined with a stabilization transport diluent for laboratory testing, maintaining nucleic acid integrity and enabling accurate PCR results, even with extended storage and transport
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A method for using a single sample suspected of containing a microorganism for both a local rapid test immunoassay and a remote laboratory test. The sample is collected from a patient at a physician's office or from the environment to be tested. The sample is collected using a swab or other implement, combined with a rapid test processing reagent and a portion of the processed sample is used for the local rapid test. The rapid test processing reagent typically consists of a buffer, a salt, and a detergent and is compatible with the local rapid test immunoassay. Only a portion of the processed sample is used for the local rapid test, leaving a remaining portion of the processed sample to be used in a remote laboratory assay. At least some of the remaining portion of the processed sample is combined with a stabilization agent that preserves at least the nucleic acid in the processed sample for the remote laboratory assay.