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MHRP Diagnostics: A Unique Capability within the DoD
MHRP’s Department of Laboratory Diagnostics and Monitoring (DLDM) conducts state-of-the-art HIV and HIV-related infections diagnostics and cutting-edge diagnostic research. The diagnostics program boasts unique capabilities that aren’t replicated within the Department of Defense (DoD). The following is a Q&A with MHRP Diagnostics Chief, Sheila Peel, MSPH, Ph.D.
What is DLDM’s diagnostics mission?
The first mission focus of MHRP was the development, optimization, and deployment of HIV diagnostic, clinical and therapeutic monitoring technologies for soldiers. It was one of two original departments—Retrovirology Diagnostics and Retrovirology Research—authorized by Congress in 1986. Today, MHRP remains a DoD leader in the development of infectious diseases diagnostic countermeasures and militarily-relevant research. Our diagnostics program is intensely focused on solving problems for the warfighter and DoD beneficiary.
What are MHRP’s clinical diagnostic capabilities?
DLDM’s HIV Diagnostics and Reference Laboratory (HDRL) provides direct HIV testing support to the U.S. Military European and Central Commands and by request to 51 medical treatment facilities. We conduct all U.S. Army HIV confirmatory testing; thus, determine the HIV infection status classification for all Army personnel.
To do this, we developed the most advanced HIV diagnostic algorithm in the U.S., setting the standard for HIV diagnostics. Additionally, we provide HIV clinical monitoring (viral load) services for all Army and Navy HIV-infected personnel and HIV resistance genotyping for all HIV-infected DoD service members. Finally, we are the Tri-Service HIV Reference laboratory and provide diagnostic consultative services and resolution of HIV and related disease infection status.
How does Diagnostics play a role in protecting soldiers?
The ability to quickly detect and sequence sexual and/or transfusion- transmitted infections—not just HIV, but others such as hepatitis C and HTLV—ensures a safe battlefield blood supply, informs clinical decision making and countermeasure development.
Emergency blood transfusion with non-FDA compliant blood products voluntarily donated by service members is a life-saving procedure used on today’s battlefields; HIV infection screening of all service members before they deploy and the use of highly sensitive and specific point-of-care (POC) tests for infection detection prior to fresh whole blood transfusion is critical for the well-being of our injured troops. We have been engaged in evaluating and selecting POC products not only for the battlefield, but areas of operation where troops do not have ready access to care.
Are you involved in HIV/AIDS threat assessment for the military?
We work closely with MHRP epidemiologists to monitor HIV infections among soldiers. Our laboratory data assists public health investigations in determining time, location and mode of acquisition for all deployment-related infections as well as identifying potential HIV transmission networks. Data we generate facilitates identification of targets for preventive interventions and informs policy development within the DoD.
What is your role in product development?
DLDM’s HDRL and Technology Assessment Laboratory evaluate and deploy new serological and molecular-based tests for HIV and related diseases. We work with many industry partners to develop, license, and acquire new assays, or “products,” to guarantee DoD is using the best products available to support the warfighter. DLDM participates in two to five premarket application FDA clinical trials for new U.S. product approvals per year; 50% of currently used FDA-licensed HIV screening and monitoring assays were evaluated in our laboratories.
How does Diagnostics support MHRP’s clinical research and global health programs?
We develop and deploy diagnostic approaches to advance MHRP’s HIV cohort, vaccine, and therapeutic clinical trials. For example, we developed a novel way to screen for HIV in RV217, the acute HIV infection study. We are currently developing a diagnostic tool to distinguish a vaccine-induced test result, or Vaccine- induced Seropositivity (VISR), from that of a true HIV infection- induced positive test. We manage MHRP’s 2.7 million sample biorepository; receiving and reposing ~60,000 samples per annum and redistributing to our collaborators ~8,000 samples per year. We support our colleagues in global health through diagnostic consultations, laboratory audits, and human and infrastructure capacity building.