PUBLIC HEALTH PREPAREDNESS & RESPONSE
The Future of Real-time PCR in the LRN-B
By Rana Rahmat , specialist , Laboratory Response Network
cost should be considered from a public health laboratory perspective .
Before the LRN-B can invest in a new testing instrument , its functionality and repeatability must be evaluated to confirm that it will produce the same results under the same conditions , regardless of where the test is performed . Protocols need to be updated and standard operating procedures either revised or written anew . The process of choosing , validating and implementing new instruments and technology is one that can take years to finalize .
Biodefense Laboratory Associate Director Michael Perry performs testing at New York State ' s Wadsworth Center . Photo : Wadsworth Center
Change is inevitable . In scientific and technological advancement , this inevitability leads to the evolution of previous iterations of technology . However , change from the status quo is not without its consequences , particularly when it comes to technology in the
Laboratory Response Network for Biological Threats Preparedness ( LRN-B ).
From Old to New
The Applied Biosystems
TM 7500 Fast Dx Real-Time Polymerase Chain Reaction ( PCR ) instrument has been a reliable workhorse for LRN-B testing for many years . In early February 2022 , the
US Centers for Disease Control and Prevention ( CDC ), issued a network broadcast message to all LRN-B laboratories announcing the discontinuation timeline for the ABI 7500 Fast Dx , with production ceasing in May 2022 and technical support being phased out by 2027 . The news has had a substantial impact on diagnostic assays throughout public health , especially for diagnostic and surveillance assays that are developed at CDC and deployed through the LRN-B and other public health laboratory programs . News of the ABI 7500 Fast Dx ’ s departure leads to a time of transition for its users as programs at CDC along with other stakeholders work together to identify the next generation of real-time PCR platforms .
Such changes are not easy to implement and take significant coordination between CDC , public health laboratories , APHL and vendors . CDC must provide guidance on any new standards , for which they must gather as much information as possible . Changes to instrumentation also require validation studies for both existing assays and the instrument and may alter existing strategic plans for future studies .
… And New Technicalities
A major limiting factor in the availability of platforms to choose from is
US Food and Drug Administration ( FDA ) 510 ( k ) clearance , an FDA requirement that manufacturers must register devices if there is an intent to market the instrument as a medical device . A realtime PCR instrument that has already received FDA 510 ( k ) clearance is preferred for CDC ’ s influenza program and the LRN-B , two groups that are a driving force in approving the use of new platforms in their respective programs . Other factors , such as throughput capacity , footprint and
While it may be difficult initially to deal with drastic deviations that have a significant impact on its member laboratories , the LRN will rise to the occasion and meet these changes head on , leading to an even stronger and well-prepared public health laboratory system . n
One of the long-term goals for APHL , CDC and public health laboratories has been to standardize testing platforms and reagents across the public health laboratory system . To achieve this , the Laboratory Efficiencies Initiative was co-sponsored by APHL and CDC with the goal to build a sustainable public health laboratory system . Over the years there has been success in homogenizing instrument use and testing across public health laboratories .
A lineup of various PCR instruments located at New York State ’ s Wadsworth Center . Photo : Wadsworth Center
24 LAB MATTERS Summer 2022