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A paper-based immunoassay to determine HPV vaccination status at the point-of-care
- Source :
- Vaccine. (46):5656-5663
- Publisher :
- The Authors. Published by Elsevier Ltd.
-
Abstract
- Objective 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. Methods 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. Results 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. Conclusions 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.
- Subjects :
- Adult
Male
Paper
medicine.medical_specialty
HPV
Point-of-care testing
Point-of-Care Systems
Serologic tests
Pilot Projects
HPV vaccines
Antibodies, Viral
Article
Serology
03 medical and health sciences
Young Adult
0302 clinical medicine
Internal medicine
Immunology and Microbiology(all)
medicine
Humans
030212 general & internal medicine
Papillomavirus Vaccines
Antigens, Viral
Point of care
Immunoassay
Human papillomavirus 16
General Veterinary
General Immunology and Microbiology
medicine.diagnostic_test
business.industry
Papillomavirus Infections
Vaccination
Public Health, Environmental and Occupational Health
Hpv vaccination
Collodion
Paper based
veterinary(all)
3. Good health
Infectious Diseases
030220 oncology & carcinogenesis
Immunology
Molecular Medicine
Female
business
Subjects
Details
- Language :
- English
- ISSN :
- 0264410X
- Issue :
- 46
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....f3f5ae19f5f05aa6c5b3d43ef3d70415
- Full Text :
- https://doi.org/10.1016/j.vaccine.2016.09.021