Molecular Diagnostics Development Laboratory
The Center's Molecular Diagnostics Development Laboratory brings together expertise and existing infrastructure of the Genomic Assay & Diagnostic Device Development Lab (GAD3 lab) and the Molecular Epidemiology Research Lab (MERL) to support discovery and development of host response diagnostic assays and next-generation point-of-care molecular diagnostic devices.
About the GAD3 Lab
The GAD3 Lab was established in partnership between CAGPM and the Pratt School of Engineering to leverage expertise of the Center in developing host-based genomic signatures of health and disease with the cutting-edge engineering and material science programs in Pratt to advance development of next-generation diagnostic technologies.
The GAD3 lab has standardized protocols and workflows to perform RNA and protein sample processing, QC, and handling, as well as to perform quantitative PCR and immunoassay measurements of specific gene products from endogenous or synthetic samples. This includes the migration of gene transcripts or protein expression signatures from whole genome discovery studies to targeted, multi-analyte assays using currently available technologies, and resulting in the development of optimized biomarkers or signatures capable of diagnosing and differentiating host gene expression profiles, and informing the content of novel sensor assays. The lab interfaces as well with the Duke -omics core facilities, including Genome Sequencing and Proteomics and Metabolomics Cores, to generate -omics data in support of genome-inspired discovery studies. Key capabilities include:
- Specimen processing and quality assessment
- Real-time qPCR with automated plate loading
- Targeted assay development, refinement, and performance assessment
The GAD3 lab has 1000 sq. ft. of dedicated wet-lab workspace located on the second floor of the Fitzpatrick CIEMAS building. The laboratory is upfitted well with infrastructure and equipment including Applied Biosystems 7900HT real-time PCR system, Agilent Bioanalyzer 2100, Nanodrop 2000, biological safety cabinets, refrigerated centrifuge and microcentrifuge, -80C freezers (monitored, alarmed, and power backup). Other equipment includes: -20C freezer and +4C refrigerator, PCR thermal cycler, gel electrophoresis systems and power supplies, hand-held liquid handling equipment, and analytic and top-loading balance.
About the MERL Lab
The MERL is a developmental extension of the Durham Veterans Affairs Medical Center Clinical laboratory, and is directed by Dr. Christopher Woods, Chief of Molecular Microbiology at the Durham VAMC and is supervised by Bradly Nicholson, PhD. The laboratory brings to bear expertise in classical clinical microbiology, epidemiology, clinical research, and molecular microbiology.
The laboratory has developed standardized operating procedures for the collection, processing, and storage of clinical research samples for use in a diverse range of clinical and epidemiological diagnostic studies. For example, the laboratory directed the sample collection, processing, and detection of diverse respiratory viral pathogens for studies that examined early phase host response diagnostic development following human challenge studies in several offsite clinical research locations. From the 7 total challenge cohorts enrolled, more than 100 volunteer subjects produced over 50,000 clinical samples that were processed and analyzed at the MERL as part of our diagnostic development program. In addition, the MERL supports several large, ongoing cohort studies for the development and validation of host response diagnostic tests. These include the Community-Acquired Respiratory Disease Study (CARDS) of Duke University Freshman and a similar study in the Durham VA Medical Center long-term care unit.
In addition to the 2400 square foot comprising the Clinical Microbiology Laboratory at the Durham VAMC, the MERL includes an additional ~1500 sf, 225 office, and 1275 wet lab of which 330 is shared space. Standard laboratory equipment includes an autoclave, laboratory oven, 2 Monitored –80°C freezers, -20°C freezer, Table Top Centrifuge (Processing blood), 3 Micro-centrifuge (Molecular assays), Agarose Gel Electrophoresis equipment & power supplies, 2 Refrigerators, a Cold Room, 2 Fume Hoods, 2 Biosafety Cabinets,1 Dead-Air Box. Other major