Polymerase chain reaction (PCR) tests are one of the most popular diagnostic tools for the detection and diagnosis of viral diseases, such as coronavirus (COVID-19), due to their ability to rapidly and accurately deliver results for guidance on treatment.
The global impact of the COVID-19 pandemic has sparked a renewed interest in molecular diagnostics, leading to an increased need for innovative testing alternatives. This demand has paved the way for the expansion of point-of-care (POC) testing options, leveraging advanced next-generation technologies that significantly reduce sample-to-answer turnaround times.
Advantages of point-of-care testing
Broadly speaking, point-of-care (POC) testing allows clinicians and patients to obtain diagnostic results at the point of use and, if the test is quick enough, during just one appointment. Where PCR is used in a POC device, this enables fast, accurate results to help inform timely treatment options for patients, even if they are asymptomatic.
The use of economical and portable POC devices can alleviate the workload in laboratories, general practitioner surgeries, and hospitals, while simultaneously boosting patient screening capacities. This, in turn, contributes to slowing the transmission of diseases by enabling efficient and widespread screening measures.
Technical challenges
Lateral flow devices, commonly used during the COVID-19 pandemic for rapid antigen testing, lack the sensitivity of lab-based PCR testing. The development of PCR-based POC testing for diseases like influenza and COVID-19 has the potential to significantly enhance patient outcomes and operational efficiencies. However, several technical challenges impede progress in this area.
- POC diagnostic test devices require portability and room temperature storage compatibility for use in GP surgeries and pharmacies.
- The reagents must perform multiple functions, including allowing viral extraction from a nasal swab while preserving lysed RNA to maintain high test sensitivity during RT-PCR.
- Reagents need to also exhibit advanced tolerance to diverse specimen inhibition, enabling amplification in the presence of non-target DNA and PCR inhibitors like cellular debris and proteins.
- Storage at room temperature is supported by lyophilization of the RT-PCR reagents, presenting a further challenge concerning fast and efficient rehydration of reagents, that need to be incorporated into an automated workflow.
- PCR-based POC tests must support rapid thermocycling to enable quick amplification of multiple targets at significantly faster speeds than current technologies.
- It is vital that whilst addressing these challenges, the test is economical and scalable to make it deliverable in care environments.
Find out how working with LGC Biosearch Technologies, the team at LEX Diagnostics developed a customised RT-PCR master mix suitable for the unique demands of fast, sensitive POC PCR testing, successfully solving the technical challenges they faced.
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