INDUSTRY MATTERS
Harnessing the Power of the Research Bench for Public Health Action
By Steven Kelly , technical product manager , Streck
Streck ARM-D ® Kits are multiplex qPCR kits capable of detecting AR variants across multiple resistance gene families , NDM , KPC , OXA-48 , VIM , IMP , OXA-143 , OXA-48 , OXA-24 / 40 , OXA-51 , OXA-58 , OXA-23 , OXA-198 , OXA-134 and OXA-372 . For Research Use Only . Not for use in diagnostic procedures . Photo : Streck .
As nucleic acid analysis technologies advance to become faster and more accurate , laboratories can acquire more genetic data for infectious diseases , cancers and hereditary diseases than ever before . However , these data are only impactful if they are verifiably correct .
To ensure accurate analysis , public health laboratories rely heavily on laboratorydeveloped tests ( LDTs ). These LDTs can range from verifying the reliability of complete blood count methodology to surveilling a hospital and surrounding community for antimicrobial-resistant microorganisms . The latter can be especially impactful , as the rapid genetic identification of the microorganisms causing an infection — and any associated antimicrobial resistance ( AR ) mechanisms — can result in faster , more appropriate treatments and improved patient outcomes . Public health programs such as the Antimicrobial Resistance Laboratory Network ( AR Lab Network ) and the National Wastewater Surveillance System ( NWSS ) rely on LDTs to verify their methods for detecting infectious disease microorganisms and resistance mechanisms .
Comprehensive and Economical LDT Options for AR Surveillance
Both the AR Lab Network and NWSS have included the Streck ARM-D ® Kits in their LDTs for AR detection and genetic confirmation of phenotypic analysis . These kits detect a comprehensive list of AR gene family variants , including NDM , KPC , OXA-48 , VIM and IMP . Because Streck ARM-D Kits have a wide range of coverage , they detect gene family variants that other kits may fail to detect , lowering the costs associated with having to retest bacterial isolates and wastewater samples and ensuring that only positive samples are sent for comprehensive whole genome sequencing .
Recent Changes to LDT Recommendations
Though laboratory technologies have advanced with relative ease , the evolution of LDTs has not been as smooth . In May 2024 , the US Food and Drug Administration ( FDA ) reached a final ruling for regulations that ensure the safety and effectiveness of LDTs , ending over a decade of discussions .
Per this rule , FDA regulations were amended to explicitly state that in vitro diagnostic products ( IVDs ) are to be considered devices under the US Food , Drug and Cosmetic Act , even when the IVD is manufactured or developed by a laboratory , as is the case with LDTs . This means that the FDA has expanded enforcement discretion with LDTs .
For laboratories that run surveillance tests that are not being used for diagnosis and / or patient treatment decisions , like the AR Lab Network and NWSS , a change in LDT regulation is less likely , as Section V . A . 2 . c ( third paragraph ) of the Final Rule states that the FDA will generally not expect compliance with these tests . In this case , we expect Streck ’ s ARM-D Kits will continue to serve as a valuable surveillance tool to support AR testing in the public health sector . g
Streck is an APHL Gold Level Sustaining Member .
8 LAB MATTERS Spring 2025
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