A paper-based immunoassay to determine HPV vaccination status at the point-of-care.
To develop and evaluate a paper-based point-of-care HPV serology test to determine if an individual has received two or more HPV immunizations.



The paper-based immunoassay was constructed using a nitrocellulose lateral flow strip with adsorbed HPV16 virus-like particles serving as the capturing moiety. Three capture zones containing virus-like particles were placed in series to allow for visual discrimination between high and low HPV16 plasma antibody concentrations. A plasma separation membrane was used to allow whole blood to be applied directly to the assay. All reagents were dried on glass fiber pads during device fabrication and were rehydrated with buffer at the time of use. A pilot study consisting of 35 subjects with a history of zero, one, two or three HPV vaccines was conducted to evaluate the immunoassay. The completed paper-based immunoassays were scanned for visual interpretation by three researchers who were blinded to the true results and separately evaluated quantitatively using MATLAB.



For the 28 tests valid for analysis, fifteen subjects reported receiving two or more HPV vaccines, three reported receiving one, and ten reported having no HPV vaccinations. The paper-based immunoassays for all fifteen subjects who reported having received two or more HPV vaccines were judged positive by all researchers. Twelve of the thirteen tests from individuals reporting one or zero vaccinations were deemed negative by all observers. One test from an unvaccinated individual was judged positive by two out of three reviewers. Quantitatively, all tests were correctly separated between the two groups.



We successfully designed and tested a HPV serology test amenable to the point-of-care. The device showed promising results in a pilot study for discriminating between those who received two or more HPV vaccinations and those who did not. Furthermore, this device offers a platform for producing other semi-quantitative point-of-care serological tests.
Department of Bioengineering, Rice University, 6100 Main Street, Houston, TX 77005, United States. Electronic address: bgrant@intven.com.
Benjamin D
BD
Grant
Department of Bioengineering, Rice University, 6100 Main Street, Houston, TX 77005, United States. Electronic address: cas16@rice.edu.
Chelsey A
CA
Smith
Global Coalition Against Cervical Cancer, United States; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Block Room 341, Bronx, NY 10461, United States. Electronic address: castle.philip@gmail.com.
Philip E
PE
Castle
Department of Hematology/Oncology, Baylor College of Medicine, ABBR R517, MS: BCM305, Houston, TX 77030, United States. Electronic address: scheurer@bcm.edu.
Michael E
ME
Scheurer
Department of Bioengineering, Rice University, 6100 Main Street, Houston, TX 77005, United States. Electronic address: rkortum@rice.edu.
Rebecca
R
Richards-Kortum
D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000276:immunology; D003101:Collodion; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D008297:Male; D010209:Paper; D030361:Papillomavirus Infections / Q000276:immunology*; D053918:Papillomavirus Vaccines / Q000276:immunology*; D010865:Pilot Projects; D019095:Point-of-Care Systems; D014611:Vaccination; D055815:Young Adult
D000914:Antibodies, Viral; D000956:Antigens, Viral; D053918:Papillomavirus Vaccines; D003101:Collodion
HPV; Point-of-care testing; Serologic tests
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