MCL: Research Platforms and Projects
Introduction
One of the primary staples of Surgical Critical Care Initiative (SC2i) is our bench to bedside approach to connection translational research to patient care. The Molecular Core Laboratory (MCL) of the SC2i for its demonstrated expertise in and commitment to biobanking. The College of American Pathologists (CAP) consequentively recognized the MCL for The CAP Accreditation Program is widely recognized as the gold standard and serves as a model for various federal, state, and private laboratory accreditation programs throughout the world. Only 73 biorepositories in the United States are currently accredited. The SC2i MCL, in coordination and unison with the Clinical Research Team and Regulatory and Laboratory Compliance Team, have identified close to 400 biorepository requirements and modified existing documents, such as the Quality Management Plan, Standard Operating Procedures, guidance documents, and training manuals.
The MCL of SC2i, which is part of the Uniformed Services University of the Health Services and the Walter Reed National Military Medical Center, received its initial biorepository accreditation in February 2020. Receiving and maintaining CAP accreditation is an exciting milestone in accomplishing the SC2i mission of developing biomarker-driven Clinical Decision Support Tools (CDSTs). The next goal for SC2i is to get FDA approval for one of their CDSTs, which requires the CAP Laboratory Accreditation Program accreditation and Clinical Laboratory Improvement Program certification of their laboratories for high complexity clinical testing.
Platforms
- MesoScale Discovery (MSD):
Meso Scale Discovery (MSD) assay is a 96-well bioanalysis immunoassay-based platform (ELISA) that utilizes electrochemiluminescence for multiplexing. Multiplexing is a technique that allows multiple analytes to be quantitated within a single well. SC2i has worked diligently to expand the detection range for 56 immunological-related analytes. These analytes have been reported to play critical roles in angiogenesis, inflammation, immune cell activation/suppression, chemotaxis, and endothelial/epithelial homeostasis. SC2i continues to enhance the identification of potential prognostic and diagnostic biomarkers that may be present in various biospecimens (serum, wound effluent, peritoneal fluid vs lavage) to aid in the development of future CDSTs.
- B·R·A·H·M·S KRYPTOR:
B·R·A·H·M·S KRYPTOR is a fully automatic, closed laboratory analysis system that can perform numerous various analyses in random-access operations using a unique measuring principle called TRACE (Time Resolved Amplified Cryptate Emission). Precision is vital for the clinical decision making process that is supported by the measuring result of a biomarker. This requires both a stable and well-defined biomarker assay and a platform that safeguards a reliable and precise measurement of the biomarker. Precision technology paves the way for the development of innovative in-vitro diagnostic reagents for diverse clinical areas. SC2i is currently expanding the range of assays is designed to run on our B·R·A·H·M·S KRYPTOR Analyzer. These assays include: 1) Procalcitonin (PCT)(21 CFR 866.3215, Class II) – identify bacterial infections and development of sepsis 2) Copeptin (AVP/ADH) – surrogate marker for vasopressin to help monitor disease progression and critically ill patients.
- Nanostring:
Nanostring is novel and dynamic new technology within the field of spatial biology and is 21 CFR Part 11 compliant. Nanostring provides a cost-effective automated solution for multiplex analysis of 800+ gene targets within a simple yet highly reproducible workflow. Gene expression can be quantified and analysis using their ready-to- or custom panels for a multitude of nucleic acid-based sample types ( Total RNA, cell lysates in GTIC, FFPE-derived total RNA and PAXgene-lysed whole blood) and research fields (immunology, oncology, infectious disease, etc). These processes help identify unique gene signatures and cellular pathways that can be utilized to make better and more informed decisions regarding patient care.
- Bioprocessing:
Meso Scale Discovery (MSD) assay is a 96-well bioanalysis immunoassay-based platform (ELISA) that utilizes electrochemiluminescence for multiplexing. Multiplexing is a technique that allows multiple analytes to be quantitated within a single well. MCL has worked diligently to expand the detection range for 56 immunological-related analytes. These analytes have been reported to play critical roles in angiogenesis, inflammation, immune cell activation/suppression, chemotaxis, and endothelial/epithelial homeostasis. MCL continues to enhance the identification of potential prognostic and diagnostic biomarkers that may be present in various biospecimens (serum, wound effluent, peritoneal fluid vs lavage) to aid in the development of future CDSTs.
- MesoScale Discovery (MSD):
- Meso Scale Discovery (MSD) assay is a 96-well bioanalysis immunoassay-based platform (ELISA) that utilizes electrochemiluminescence for multiplexing. Multiplexing is a technique that allows multiple analytes to be quantitated within a single well. MCL has worked diligently to expand the detection range for 56 immunological-related analytes. These analytes have been reported to play critical roles in angiogenesis, inflammation, immune cell activation/suppression, chemotaxis, and endothelial/epithelial homeostasis. MCL continues to enhance the identification of potential prognostic and diagnostic biomarkers that may be present in various biospecimens (serum, wound effluent, peritoneal fluid vs lavage) to aid in the development of future CDSTs.