This effort grew out of the need to develop a highly sensitive, field-deployable platform to be used as a primary screening and early detection tool for serologic biomarkers for the high-risk human papillomavirus (hrHPV) infection. A hrHPV infection is a precursor for developing high-grade cervical intraepithelial neoplasia (CIN 2/3+). Early detection requires high sensitivity and a low limit-of-detection (LOD). To this end, the developed platform (DxArray) takes advantage of the specificity of immunoassays and the selectivity of fluorescence for early disease detection. The long term goal is to improve the quality of life for several hundred million women globally, at risk of being infected with hrHPV.
The developed platform uses fluorescent labels over the gold-standard colorimetric labels in a compact, high-sensitivity lateral flow assay configuration. It is also compatible with POC settings as it substitutes expensive and bulky light sources for LEDs, low-light CMOS cameras, and photomultiplier tubes for photodiodes, in a transillumination architecture, and eliminates the need for expensive focusing/transfer optics. The platform uses high-quality interference filters at less than $1 each, enabling a rugged and robust design suitable for field use.
The limit of detection (LOD) of the developed platform is within an order of magnitude of centralized laboratory diagnostic instruments. It enhances the LOD of absorbance or reflectometric and visual readout lateral flow assays by 2 - 3 orders of magnitude. This system could be applied toward any chemical or bioanalytical procedure that requires a high performance at low-cost.
The knowledge and techniques developed in this effort is relevant to the community of researchers and industry developers looking to deploy inexpensive, quantitative, and highly sensitive diagnostic devices to resource-limited settings.
Human papillomavirus (HPV) 16 proteins of interest, E7, E6 and CE2 were expressed and purified in E. coli for detection of specific antibodies using lateral flow assay because viral and host factors impact the serologic responses to HPV early antigens in HPV-positive oropharyngeal cancer. 17 samples and 5 controls with already known antibody reactivity from ELISA analysis were selected for HPV serologic responses. The lateral flow strip was evaluated for its color band intensity using Image J software. Peak area was used to quantify the color intensity of the lateral flow strip. Out of the 17 samples, 11 (64.7%) showed high antibody levels to E7, 12 (70.6%) showed high Ab levels to E6 and 6 (35.3%) showed high Ab levels to CE2. Correlation coefficient between antibody detection by sight and ELISA for E7, CE2 and E6 were 0.6614, 0.4845 and 0.2372 respectively and correlation coefficient between lateral flow assay and ELISA for E7, CE2 and E6 were 0.3480, 0.1716 and 0.1644 respectively. This further proves patients or samples with HPV 16 oropharyngeal cancer have detectable antibodies to early E7, E6 and E2 proteins, which are potential biomarkers for HPV-associated oropharyngeal cancer.
The purpose of this study was to examine the effect of educational videos on Human Papillomavirus (HPV) vaccination intent among young adults aged 18-26. A two-group randomized control trial (RCT) is conducted among 156 individuals (control group n = 79, intervention group n= 77). Inclusion criteria were English-speaking young adults aged 18-26 who have not been vaccinated against HPV. Participants who met the inclusion criteria based on an online screening form were recruited via Amazon Mechanical Turk (MTurk) and invited to join the study. They first completed a pretest (T0) online via REDCap, randomly assigned to the intervention or control group, and completed a posttest (T1) after viewing their assigned intervention. Participants assigned to the intervention group watched two brief animated videos while participants assigned to the control group examined an HPV educational brochure created by the Centers for Disease Control and Prevention (CDC). Guided by the Theory of Planned Behavior, survey questions measured HPV-related knowledge, attitudes, perceived severity, perceived susceptibility, vaccination intent (T0 and T1), sociodemographic characteristics, and health history (T0 only) of participants. The results showed the intervention group had an increase in vaccination intent while the control group had a decrease in vaccination intent. This shows that video education methods are more effective than traditional written education methods at increasing vaccination intention among young adults.