INDUSTRY MATTERS
What ’ s Next for Respiratory Diagnostic Testing by Emily Berlin , vice president , Marketing and Product Management , Cardinal Health
If there can be a positive takeaway from the COVID-19 pandemic , it would be the rapid and innovative diagnostic progress that has been made so far . The major strides the diagnostics community has made in developing new respiratory pathogen tests , methodologies and approaches in such a short time will have a lasting impact on healthcare moving forward .
In addition to test development , the pandemic has also raised the level of public awareness of laboratory testing . With schools , businesses and organizations of all kinds now employing COVID-19 testing , the public has become accustomed to more frequent testing and the ability to access testing in more settings .
The Rise of Molecular Point-of-care Testing
While molecular point-of-care ( POC ) test menus are still maturing — currently limited to respiratory infections and strep — the benefits of near-patient technologies and testing assays are clear . Decentralized POC testing can deliver rapid , accurate results to patients without the need for sample transport . There is potential to continue expanding new testing locations , as was seen with drivethrough COVID-19 testing , to increase convenience and minimize patient exposure .
The Growth of At-home Testing
In the early stages of the pandemic , the only at-home testing option available to the public was collection kits , where samples are collected at home and sent off to a laboratory for processing . Collection kits offer the benefit of PCR results without having to leave the house , but the wait for a result is much longer than for a true at-home test .
Today , there are several products available on the market for at-home COVID-19 detection . Rapid antigen tests include the Abbott BinaxNOW™ COVID-19 antigen self-test ( which received FDA Emergency Use Authorization ( EUA ) in December 2020 ) and the Quidel QuickVue At-Home OTC COVID-19 test ( which received FDA EUA in March 2021 .) In addition to antigen tests , Cue Health released the nation ’ s first molecular diagnostic test ( which received FDA EUA , November 2021 ) for at-home use without a prescription and is being distributed by Cardinal Health .
Doing More with Less
Multiplex testing for more than one type of virus has become more common , particularly with the concurrence of COVID-19 and influenza . Multiplex testing enables physicians to make more comprehensive diagnoses for patients presenting with multiple symptoms associated with multiple viral respiratory infections , like SARS-CoV-2 , influenza A and B and RSV . For laboratories , multiplex testing helps reduce waste and costs through the use of fewer consumables .
Genomic Sequencing to Detect Variants
Because viruses are constantly mutating , genomic sequencing is critical to learning more . In a worst-case scenario , there is potential for a SARS-CoV-2 variant to emerge that is both immunity- and vaccine-resistant . This means that we may see a greater number of laboratories start performing genetic sequencing .
A new development in genome sequencing is the recently announced collaboration between Cue Health and Google Cloud that enables real-time respiratory viral variant sequencing and tracking through artificial intelligence ( AI ). Technology that combines genome sequencing with AI-enabled predictive capabilities has potential to shape public health .
What Lies Beyond the Pandemic ?
What does all this mean for respiratory diagnostics moving forward ? It is likely that the trends we are seeing will continue in some manner . Ideally , the positive developments that have stemmed from the pandemic will continue , and the diagnostics landscape will see further collaboration and innovation .
What is clear is how the pandemic has shaped the expectations of both patients and clinicians moving forward . The tests and technology that enable faster results , improve the patient experience , save laboratorians time and empower clinicians will likely make the biggest impact on public health . n
Reference
Cardinal Health is an APHL Gold Level Sustaining Member .
20 LAB MATTERS Summer 2022