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Next-Gen Rapid Testing and Point-of-Care Diagnosis for Oral Pathogens

AIDS and Immunosuppression Program
Integrative Biology and Infectious Diseases Branch
Division of Extramural Research


OBJECTIVE
The high demand for improved rapid tests and point of care (POC) diagnostics for oral infections and cancers is driven by global health problems. In order to improve patient care and stem disease epidemics, there is a need to bring quick, robust and exquisitely accurate diagnosis to all at risk populations. Improved diagnostics could save, extend and improve lives. Nevertheless, early diagnosis and rapid treatment initiation face challenges due to the lack of next generation clinical diagnostic tools with improved sensitivity and specificity. The goal of this initiative is to support research projects focused on producing rapid tests and POC diagnostic devices for detecting oral pathogens using oral biospecimens and disease biomarkers with exquisite sensitivity and specificity. Specifically, this initiative will stimulate research to: 

  • Develop, validate and optimize the 4th generation of oral biospecimen-based rapid tests for the detection of pathogens such as HIV, oral HPV, EBV, KSHV, CMV, BKV, and bacterial and fungal species causing oral diseases
  • Develop, validate and optimize POC devices using oral biospecimen for clinical diagnosis in resource-limited settings and in POC settings outside the traditional clinic without the use of adjunctive laboratory equipment
  • Focus on diagnostic technologies that can detect more than one oral pathogen at a time
  • Optimize assays and POC devices to determine changes in thresholds of pathogen load to link them with disease development, clinical manifestations and progression
  • Utilize an optimal visual format for unambiguous test results, that can be reliably transferred electronically to central databases, and that use the appropriate positive and negative internal controls

BACKGROUND
Accurate and prompt delivery of clinical care in oral medicine relies on early detection and early and exquisitely accurate identification of disease that are often based on the detection of disease-causing pathogens or disease biomarkers present in oral biospecimens. Diagnostics tests that would have more clinical utility would be simple and sturdy enough to identify disease outside of traditional healthcare settings. Such tests could be administered in settings such as homes, stores, schools, markets, remote villages and other resource poor places where populations gather and could be effectively screened. The goal of this initiative is to promote research to improve the sensitivity, specificity and robustness of existing assays, and to create the next generation of rapid tests and POC devices needed to enhance rapid clinical diagnosis for screening and monitoring of oral diseases effectively at the POC. For this purpose, the rapid tests and POC devices that have the greatest clinical utility are those that require minimal laboratory equipment and involve few steps and handling, represent low costs, involve easy to use procedures, require noninvasive or minimally invasive collection of oral biospecimens, deliver reliable and electronically transferable results promptly and securely, and are optimized for high-throughput multiplex detection of oral pathogens and diseases biomarkers. In addition, oral biospecimens-based rapid tests and POC devices offer the advantage of serving special populations such as children and the elderly at POC, or in clinical situations during which standard volumes of blood typically used in standard assays cannot be obtained.

The successful implementation of the “test and treat” strategy for screening, monitoring and treating HIV infection and its comorbidities to manage the HIV epidemic depends on the development and application of state-of-the-art emerging technologies. For example, while substantial advances have been made in developing and applying rapid diagnostic tools for HIV, less progress has been made for the equally rapid diagnosis of AIDS-related infectious comorbidities. Yet, per epidemiological reports, some of these infectious comorbidities such as oral candidiasis, caused by Candida albicans, and HPV-associated oral cancer, seem to be persisting or increasing in some populations whether or not they receive antiretroviral therapy (ART). Further, the situation is less clear for the rapid diagnosis of persisting agents such as KSHV, the etiological agent for oral and systemic Kaposi’s sarcoma; EBV, causing Hairy Leukoplakia; and HSV, inducing Vestibular Neuronitis and Oral Ulceration. For these agents that latently persist in oral cells, pathogen detection is insufficient to diagnose the associated oral diseases. Therefore, measuring changes in viral load thresholds through rapid tests and POC devices is necessary to quickly tie them with pathology, disease development, clinical manifestations, progression and the subsequent remission upon effective treatment.

Examples of research topics of interest for this initiative include, but are not limited to: 

  • Developing innovative rapid diagnostic approaches and POC devices that could be used in settings outside the traditional clinic for initial screening, diagnosis and monitoring of pathogens and biomarkers linked to oral diseases
  • Applying advanced technologies such as those using nanomaterials, microfluidics and chip-based diagnostics that include algorithms to perform diverse assays on a single platform, and that improve oral fluid-based assay sensitivity and specificity, miniaturization in POC device design, and high-throughput multiplex detection of oral pathogens and biomarkers for oral diseases
  • Developing novel, rapid tests and POC devices to detect a low number of copies of nucleic acids for oral pathogens in latently infected oral cells and tissues as well as pathogen persistence and reactivation in oral reservoirs
  • Developing, standardizing and validating rapid diagnostic tools and POC devices to reliably measure surrogate biomarkers indicative of responses to therapeutic strategies, including HIV and oral pathogen drug resistance and adherence to treatment

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This page last updated: February 26, 2014