PUBLIC HEALTH PREPAREDNESS AND RESPONSE
LRN Laboratories Perform Multicenter Evaluation of Automated Nucleic Acid Extraction Platforms
By Jennifer Diethelm , MPH , specialist , Laboratory Response Network
Nucleic acid extraction is vital to the Laboratory Response Network ( LRN ) for identifying biological threat agents . Scientists use extraction methods to isolate nucleic acids from samples , which can then be amplified using standardized LRN protocols . The method may be done manually or with automated systems depending on the complexity of the sample type and available equipment .
In 2020 , the State Hygienic Laboratory at the University of Iowa and the New York State Department of Health Wadsworth Center , in collaboration with APHL and the
US Centers for Disease Control and Prevention ( CDC ), completed a multicenter evaluation ( MCE ) comparing existing automated nucleic acid extraction technology — the Roche
™ MagNA Pure Compact — with the next generation of systems — the QIAGEN EZ1
® Advanced XL and Roche
™ MagNA Pure 24 . These automated extraction systems are critical in replacing the existing systems being phased out by vendors . Results from the study concluded these two systems performed equally well to the Roche
™ MagNA Pure Compact .
This study is only one of many examples that highlights the significance of MCEs to public health . Michael Perry , MS , MS Ed , associate director , Biodefense Laboratory at New York State Department of Health - Wadsworth Center , who assisted in this study , describes his experience in conducting and managing these evaluations for his laboratory .
The RocheTM MagNA Pure 24 , evaluated during the MCE for automated nucleic acid extraction platforms . Photo : New York State Department of Health Wadsworth Center
The QIAGEN EZ1 ® Advanced XL , evaluated during the MCE for automated nucleic acid extraction platforms . Photo : State Hygienic Laboratory at the University of Iowa .
How does a laboratory conduct an MCE ?
Our laboratory follows strict guidelines when validating new assays and instruments . New York State is unique in that if a clinical test is being offered , the laboratory must conduct a method validation and submit all of the validation materials to the New York State Department of Health for approval . These method validation requirements also hold true for any test offered at the Wadsworth Center . For example , when our laboratory conducts a validation we follow a strict set of guidelines , which include submitting a completed standard operating procedure , test requisition and reports , references and the validation data .
Why are MCEs important to the LRN ?
Much like what would occur in our laboratory , validations are important for the LRN as well . Before laboratories commit to buying new instrumentation or investing in new assays or reagents , it is vital to determine the functionality of the change . Additionally , an MCE shows that the assay , procedure or instrument can be run in multiple laboratories while obtaining the same results . This reminds me of a form of “ McDonaldization ” in which no matter which LRN laboratory is testing the specimen , you can be confident that the test will be treated the same way and similar results will be obtained .
How have MCEs helped your lab prepare for the future ?
MCEs have helped our laboratory determine which new assays we should be transitioning to . As with any assay used to govern public health decision making , a critical performance element of a diagnostic assay ’ s performance includes the limit of detection ( LOD ). Understanding the LOD and limitations of these assays is critical for the administrative decision making by federal , state and local emergency management and public health laboratories .
MCEs are vital to the success of the LRN and its ability to respond to threats . Through the collaborative efforts of member laboratories , CDC and APHL , these studies also enable the LRN to continue modernizing as technology advances and ensure the Network is equipped with robust and reliable systems . n
The Laboratory Response Network serves as the nation ’ s laboratory emergency response system for all-hazard threats . This includes biological , chemical and radiological threats as well as emerging infectious diseases . To stay ahead of these threats the LRN works continuously with CDC subject matter experts and member laboratories to perform multicenter evaluations , which are key to replacing outdated platforms and integrating advanced technology and assays into the Network .
26 LAB MATTERS Fall 2020