Laboratory of Viral Diagnostic (LVD)
The Laboratory of Viral Diagnostics (LVD) is a research unit that specializes in clinical trials, development of a variety simple and advanced of medical tests, and provides services for other investigators. Educational programs are offered, primarily to international colleagues. Although viral infectious diseases are targeted, research is also conducted on parasitic infections, bacterial infections, cellular analysis, and prion detection. Test platforms vary from simple and rapid assays to sophisticated combinations of molecular and serologic assays. In addition, the activities include dedicated quality assurance programs that meet FDA standards, Good Laboratory Practices, high level processing and shipping, and data management.
The LVD develops, refines, and evaluates a number of serologic and nucleic acid tests, primarily for HIV, hepatitis B&C, and herpes viruses (HSV, HHV-8, HTLV). In addition, current or past activities include the development of simple and manual tests for CD4 levels, development and application of novel serologic techniques (including simple and rapid tests), assays to determine HIV incidence (S/LS or TRI tests), and combination tests to detect more than one infectious agent simultaneously. Among the international studies are those for prevalence, incidence, establishing QA and QC programs, designing laboratories, and providing support for a number of studies.
The LVD has been a clinical site for all 7 of the FDA licensed HIV rapid tests, and is currently performing several large trials for FDA approval and/or 510K submissions. Included in the trials are local recruitment of high risk, low risk, and positive subjects, collection of a variety of types of samples, local and reference testing, managing data, and compliance with all IRB, FDA, and Maryland agencies. The LVD possesses a large sample repository, including serum/saliva pairs, seroconversion panels, and samples from all risk groups. Many of the samples were collected by the staff or international collaborators from many countries. Fee-for-service activities include systematic sample processing, storage, and archiving, and test evaluations.
The LVD is headed by Dr. Niel Constantine, Ph.D. (MT (ASCP) who acts as the Principle Investigator for the studies. He is also Director of the CAP-accredited Clinical Immunology Laboratory at the University of Maryland Medical Center, where a large number of tests are performed for infectious agents, autoimmune diseases, cancer biomarkers, and cell counts by flow cytometry
The Laboratory of Viral Diagnostics, housed in the Institute of Human Virology at the University of Maryland Baltimore possesses the following capabilities:
LVD activities for IRB reviewed and FDA approved clinical studies
Click on the the Clinical Trials Overview
List of participating clinics