INDUSTRY MATTERS
The Role of High-Throughput Open Channel Platforms in a Pandemic Response and Beyond
by Ashley Nenninger , PhD , Scientific Affairs , Hologic
In the face of a rapidly emerging public health threat , an equally rapid diagnostic response is critical . As SARS-CoV-2 accelerated into a pandemic , public health laboratories were called to manage the significant diagnostic challenges presented by this global crisis and act quickly to implement new assays while dealing with an overwhelming testing volume never before experienced .
Open channel automated platforms are well-suited to meet these specific challenges , allowing swift implementation of laboratory developed tests ( LDTs ) to address new , urgent diagnostic needs while still providing high-volume testing capacity . Compared to the manual workflows traditionally used to run LDTs , automation significantly alleviates hands-on labor requirements , giving staff more walkaway time for other tasks .
Open channel automated systems give individual labs the opportunity to quickly make high-throughput LDTs available during outbreak responses , potentially ahead of availability of manufacturerdeveloped tests . As shown by Cordes and Heim , previously published SARS-CoV-2 real time PCR assays targeting the E and RdRp genes were readily adapted for use on a fully automated open channel platform — the Panther Fusion ® system — prior to commercial test availability . 1 Details of the primer / probe sets and cycling protocol were included in the publication , allowing other Panther Fusion instrument users to quickly adopt these LDTs in their labs .
While the open channel feature of the Panther Fusion ® system ( Open Access ™ ) gave individual labs the agility to rapidly develop SARS-CoV-2 LDTs , 1 it also allowed for expedited Emergency Use Authorization ( EUA ) test development by Hologic . The Panther Fusion SARS-CoV-2 assay made use of an established Hologic product , the Open Access Enzyme Cartridge , which contains dNTPs , enzymes and buffer necessary for RT-PCR reactions , and only required design and validation of SARS-CoV-2-specific primers and probes . This expedited test development led to an EUA test early in the pandemic response on March 16 , 2020 .
Beyond their utility in outbreak response efforts , open channel platforms enable laboratories to build upon an in vitro diagnostic ( IVD ) test menu with LDTs . Test menus can be customized based on local infectious disease or public health challenges , changing clinical needs facing specific communities , patient testing needs for which a commercially available test does not exist , or platform consolidation where even low-volume , esoteric tests can be kept in-house rather than sent out . The Panther Fusion ® system can run IVDs alongside LDTs , using the same eluate from a single sample extraction . This was recently demonstrated by Stellrecht et al ., where a Flu A / B / RSV IVD assay was complemented with influenza A typing LDTs . 2 The influenza A typing LDTs run on the Panther Fusion ® system had clinical sensitivities superior to other commercially available Flu A assays ; meanwhile , the automation and platform consolidation improved laboratory efficiency and reduced labor needs significantly .
When the coronavirus pandemic subsides , automated platforms with an open channel feature will continue to provide flexibility to adapt test menus as routine testing needs evolve , while maintaining high-throughput , rapid response capabilities when future public health threats emerge . n
1
Cordes AK , Heim A . Rapid random access detection of the novel SARS-coronavirus-2 ( SARS-CoV-2 , previously 2019-nCoV ) using an open access protocol for the Panther Fusion . J Clin Virol . 2020 ; 125:104305 .
2
Stellrecht KA , Cimino JL , Maceira VP . The Panther Fusion system with Open Access functionality for laboratorydeveloped tests for influenza A virus subtyping . J Clin Microbiol . 2020 ; 58 : e00188-20 .
Hologic is a Diamond Sustaining Member of APHL .
The Panther Fusion ® SARS-CoV-2 assay :
• has not been FDA cleared or approved ;
• has been authorized by FDA under EUA for use by authorized laboratories ;
• has been authorized only for detection of nucleic acid from SARS-CoV-2 , not for any other viruses or pathogens ;
• is only authorized for the duration of the declaration that circumstances exist justifying authorization of emergency use of IVD tests for detection and / or diagnosis of COVID-19 under Section 564 ( b )( 1 ) of the Act , 21 U . S . C . § 360bbb-3 ( b )( 1 ), unless authorization is terminated or revoked sooner .
A scientist loads Open Access cartridges onto the Panther Fusion system . Photo : Hologic
18 LAB MATTERS Winter 2021