Molecular Detection and Characterization
Molecular based laboratory testing was initiated in 1997 as a new service to the Commonwealth of VA with testing performed on a very limited basis. As the volume of testing increased these activities were reorganized into its own analytical group called the Molecular Detection and Characterization (MDC) Group. Today, more than 118,000 molecular tests are performed annually on over 86,000 specimens from across the Commonwealth. The MDC group performs testing for many local, state, and federal partners including the Virginia Department of Health, the Virginia Department of Agriculture and Consumer Services, the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the State Department, the Department of Homeland Security, the Centers for Disease Control and Prevention (CDC), and the Federal Bureau of Investigation (FBI).
The MDC group uses state-of- the art technologies to rapidly detect biological agents and toxins that are of public health importance or that could be potentially associated with bio-terrorism activity. To fully characterize the organisms at the molecular level, the group uses both novel and well-established molecular-based testing approaches. Collectively, these testing services are critical to minimizing disease transmission and limiting statewide morbidity and mortality during local, state, and national disease outbreaks. The MDC group at DCLS continues to take the lead with respect to testing for novel or emerging infectious diseases.
Notable molecular testing highlights include:
- Shortening the time for Bordetella pertussis (Whooping Cough) detection from 4-10 days to less than 5 hours by employing real-time Polymerase Chain Reaction (PCR) technology.
- Early detection of the emerging West Nile and Severe Acute Respiratory Syndrome (SARS) viruses in 2000-2003. The West Nile testing program enabled the Commonwealth to track the spread of the virus in birds and mosquitoes and initiated a process for testing large numbers of specimens in a very short time. High throughput PCR procedures established for WNV testing were invaluable during the 2009 influenza pandemic and enabled rapid real-time result reporting.
- PCR testing allowed for the routine detection of Norovirus in outbreak related situations beginning in 1999. Prior to molecular detection techniques, Norovirus was not readily detectable in public health settings. Norovirus is now considered the most common cause of acute gastroenteritis in the United States.Molecular testing is instrumental to the rapid detection and characterization of these highly infectious viruses. DCLS has participated in the CDC CaliciNet program since its founding in 2009, to aid in the national tracking and characterization of outbreak-related Norovirus strains.
- MDC detected Bacillus anthracis, the causative agent of Anthrax, in postal workers from Northern Virginia postal facilities following the Anthrax attacks of 2001. DCLS was able to detect Bacillus anthracis in nearly an hour of receipt of specimens utilizing real-time PCR methods. DCLS also assisted the CDC/APHL and the New Hampshire Public Health Laboratories in characterizing a NH gastrointestinal anthrax outbreak in 2009.
- DCLS is the only confirmatory Laboratory Response Network (LRN) reference laboratory in the Commonwealth that can use rapid molecular detection methods to identify bioterrorism-threat agents in clinical and environmental specimens. In 2014, DCLS was designated as one of 12 national Advanced Reference laboratories for the LRN. A few of the threat agents that can be detected are Bacillus anthracis, Yersinia pestis, Ricin toxin, and Francisella tularensis. DCLS has assisted the national LRN program in multi-lab validations of new test methods, proficiency testing evaluations prior to distribution of the panels to all LRN laboratories, and assessments of new technologies. MDC also works with our federal partners FBI, EPA, DHS, and the State Department in the critical detection of threats to public health in the Commonwealth and nationally.
- DCLS has been a member of the Food Emergency Response Network (FERN) since its inception in 2004. DCLS Scientists are trained to use FERN methods for rapid molecular detection of foodborne and biothreat agents from food matrices and have participated in numerous surveillance exercises including the 2012 national Presidential nomination conventions and the 2013 Presidential Inauguration.
- In 2006, MDC was able to rapidly deploy a new PCR test method to meet the growing concerns over cases of Mumps in the Commonwealth. In 2013, MDC was again able to assist the VDH in detecting and tracking the spread of Mumps cases in university outbreaks across the Commonwealth.
- In 2009, MDC performed a same day validation of the newly released molecular detection method for the pandemic H1 strain of influenza. The rapid kit deployment and validation allowed DCLS to confirm and track pandemic flu in the Commonwealth as soon as the kit was released. The DCLS MDC lab was the only laboratory in Virginia capable of performing the rapid molecular detection for public health and safety purposes. The CDC partnered with the MDC group at DCLS to validate the new kit for the diagnosis of human influenza infections and the highly pathogenic influenza A (H5N1) viruses. The kit was later released for diagnostic use to all 50 states.
- In 2011, MDC validated a PCR assay for the detection of Measles virus. Our first molecular detection of Measles virus occurred in 2014.
- MDC performs nucleic acid amplification testing for the VDH Division of Disease Prevention to detect the sexually transmitted Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) organisms submitted by VDH STD and Family Planning clinics. This testing provides the public health infrastructure to detect and treat affected individuals and to prevent further spread of disease.
- MDC has partnered with the DCLS Newborn Screening group to implement molecular testing, and enhancing screening analyses, for Cystic Fibrosis in newborns.
- The MDC group at DCLS routinely improves the detection of pathogens or disease conditions with the evaluation of new technologies and instrumentation. A few of the latest test offerings include Measles, H7N9 influenza currently circulating in China, the Novel 2012 Middle Eastern Respiratory Syndrome - Coronavirus (MERS-CoV) circulating in parts of Europe and the Middle East, a respiratory virus panel that can simultaneously identify 7 different viruses from a single specimen, Salmonella “serotyping” by molecular methods, and Whole Genome Sequencing of select food borne related pathogens through a collaboration with the FDA.
- In August of 2014, the DCLS was designated as one of 13 laboratories nationwide qualified and approved by the CDC to perform the Department of Defense (DOD) Emergency Use Authorization (EUA) Ebola Zaire (EZ1) rRT-PCR TaqMan® assay. DCLS is the only laboratory in Virginia that has this testing capability.
- Bordetella pertussis (distinguishing between Bordetella pertussis and Bordetella holmesii).
- Shiga-toxin producing Escherichia coli (STEC) including, E. coli O157:H7
- Plasmodium Speciation (Malaria)
- Influenza, including 2009 pandemic H1N1 strain, highly pathogenic H5N1 and the emerging H7N9 strains.
- Select Agents using LRN molecular methods
- Foodborne and high threat agents using FERN molecular methods
- MERS-CoV (2012 novel Coronavirus)
- Respiratory virus panel (including: Adenovirus, RSV, hMPV, Influenza, Parainfluenza, and Rhinovirus)
- Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC)
- Salmonella serotyping