Microfluidics-based point-of-care test for serodiagnosis of Lyme Disease

Scientific Reports

Volumn 6, Issue , 2016, Pages

  Nayak, Samiksha ^a   Sridhara, Archana ^a   Melo, Rita ^b   Richer, Luciana ^c   Chee, Natalie H ^a   Kim, Jiyoon ^a   Linder, Vincent ^d   Steinmiller, David ^d   Sia, Samuel K ^a   Gomes Solecki, Maria ^b,c  

^a Department of Earth and Environmental Sciences   (United States)

^b UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^c Immuno Technologies Inc   (United States)

^d OPKO Health Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL ANTIGEN; BACTERIUM ANTIBODY;

BLOOD; BORRELIA BURGDORFERI; HUMAN; IMMUNOLOGY; LYME DISEASE; MICROFLUIDICS; POINT OF CARE SYSTEM; PROCEDURES; SENSITIVITY AND SPECIFICITY; SEROLOGY; TIME FACTOR;

ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BORRELIA BURGDORFERI; HUMANS; LYME DISEASE; MICROFLUIDICS; POINT-OF-CARE SYSTEMS; SENSITIVITY AND SPECIFICITY; SEROLOGIC TESTS; TIME FACTORS;

EID: 84991461047     PISSN: None     EISSN: 20452322     Source Type: Journal    
DOI: 10.1038/srep35069     Document Type: Article

References (37)

1. Hanincova, K., Kurtenbach, K., Diuk-Wasser, M., Brei, B. & Fish, D. Epidemic spread of Lyme borreliosis, northeastern United States. Emerg. Infect. Dis. 12, 604-611, doi: 10.3201/eid1204.051016 (2006).
2. CDC. (ed Bacterial Diseases Branch CDC) (2011).
3. Young, J. D. Underreporting of Lyme disease. N. Engl. J. Med. 338, 1629, doi: 10.1056/NEJM199805283382216 (1998).
4. Kuehn, B. M. CDC estimates 300, 000 US cases of Lyme disease annually. Jama 310, 1110, doi: 10.1001/jama.2013.278331 (2013).
5. Steere, A. C. Lyme disease. N. Engl. J. Med. 321, 586-596, doi: 10.1056/NEJM198908313210906 (1989).
6. Shapiro, E. D. Clinical practice. Lyme disease. N. Engl. J. Med. 370, 1724-1731, doi: 10.1056/NEJMcp1314325 (2014).
7. Schutzer, S. E. et al. Atypical erythema migrans in patients with PCR-positive Lyme disease. Emerg. Infect. Dis. 19, 815-817, doi: 10.3201/eid1905.120796 (2013).
8. Pritt, B. S. et al. Identification of a novel pathogenic Borrelia species causing Lyme borreliosis with unusually high spirochaetaemia: a descriptive study. Lancet Infect. Dis., doi: 10.1016/S1473-3099(15)00464-8 (2016).
9. CDC. Recommendations for test performance and interpretation from the second national conference on serologic diagnosis of Lyme disease. MMWR, Morb Mortal Wkly Rep 590-591 (1995).
10. Liang, F. T. et al. Sensitive and specific serodiagnosis of Lyme disease by enzyme-linked immunosorbent assay with a peptide based on an immunodominant conserved region of Borrelia burgdorferi vlsE. J. Clin. Microbiol. 37, 3990-3996 (1999).
11. Nowakowski, J. et al. Laboratory diagnostic techniques for patients with early Lyme disease associated with erythema migrans: a comparison of different techniques. Clin. Infect. Dis. 33, 2023-2027, doi: 10.1086/324490 (2001).
12. Gomes-Solecki, M. J. et al. A first-tier rapid assay for the serodiagnosis of Borrelia burgdorferi infection. Arch. Intern. Med. 161, 2015-2020 (2001).
13. Gomes-Solecki, M. J. et al. Recombinant assay for serodiagnosis of Lyme disease regardless of OspA vaccination status. J. Clin. Microbiol. 40, 193-197 (2002).
14. Wormser, G. P. et al. Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease. Diagn. Microbiol. Infect. Dis. 75, 9-15, doi: 10.1016/j.diagmicrobio.2012.09.003 (2013).
15. Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I. & Wormser, G. P. Diagnosis of lyme borreliosis. Clin. Microbiol. Rev. 18, 484-509, doi: 10.1128/CMR.18.3.484-509.2005 (2005).
16. Marques, A. R. Laboratory diagnosis of Lyme disease: advances and challenges. Infect. Dis. Clin. North Am. 29, 295-307, doi: 10.1016/j.idc.2015.02.005 (2015).
17. Wormser, G. P. et al. Comparative cost-effectiveness of two-tiered testing strategies for serodiagnosis of lyme disease with noncutaneous manifestations. J. Clin. Microbiol. 51, 4045-4049, doi: 10.1128/JCM.01853-13 (2013).
18. Gomes-Solecki, M. J., Meirelles, L., Glass, J. & Dattwyler, R. J. Epitope length, genospecies dependency, and serum panel effect in the IR6 enzyme-linked immunosorbent assay for detection of antibodies to Borrelia burgdorferi. Clin. Vaccine Immunol. 14, 875-879, doi: 10.1128/CVI.00122-07 (2007).
19. Chin, C. D. et al. Microfluidics-based diagnostics of infectious diseases in the developing world. Nat. Med. 17, 1015-1019 (2011).
20. Guo, T., Patnaik, R., Kuhlmann, K., Rai, A. J. & Sia, S. K. Smartphone dongle for simultaneous measurement of hemoglobin concentration and detection of HIV antibodies. Lab on a Chip 15, 3514-3520 (2015).
21. Laksanasopin, T. et al. A smartphone dongle for diagnosis of infectious diseases at the point of care. Science translational medicine 7, 273re271-273re271 (2015).
22. Chin, C. D. et al. Mobile device for disease diagnosis and data tracking in resource-limited settings. Clin. Chem. 59, 629-640 (2013).
23. Linder, V., Sia, S. K. & Whitesides, G. M. Reagent-loaded cartridges for valveless and automated fluid delivery in microfluidic devices. Anal. Chem. 77, 64-71 (2005).
24. Salami, S. S. et al. In Urologic Oncology: Seminars and Original Investigations 566-571 (Elsevier, 2013).
25. O'Bryant, S. E. et al. A serum protein-based algorithm for the detection of Alzheimer disease. Arch. Neurol. 67, 1077-1081 (2010).
26. Binnicker, M. J. et al. Evaluation of two commercial systems for automated processing, reading, and interpretation of Lyme borreliosis Western blots. J. Clin. Microbiol. 46, 2216-2221, doi: 10.1128/JCM.00200-08 (2008).
27. Theel, E. S. The Past, Present and (Possible) Future of Serologic Testing for Lyme Disease. J. Clin. Microbiol., doi: 10.1128/ JCM.03394-15 (2016).
28. Ivanova, L. et al. Comprehensive seroprofiling of sixteen B. burgdorferi OspC: implications for Lyme disease diagnostics design. Clin. Immunol. 132, 393-400, doi: 10.1016/j.clim.2009.05.017 (2009).
29. Vaz, A. et al. Cellular and humoral immune responses to Borrelia burgdorferi antigens in patients with culture-positive early Lyme disease. Infect. Immun. 69, 7437-7444, doi: 10.1128/IAI.69.12.7437-7444.2001 (2001).
30. Coleman, A. S. & Pal, U. BBK07, a dominant in vivo antigen of Borrelia burgdorferi, is a potential marker for serodiagnosis of Lyme disease. Clin. Vaccine Immunol. 16, 1569-1575, doi: 10.1128/CVI.00301-09 (2009).
31. Coleman, A. S. et al. BBK07 immunodominant peptides as serodiagnostic markers of Lyme disease. Clin. Vaccine Immunol. 18, 406-413, doi: 10.1128/CVI.00461-10 (2011).
32. Liang, F. T. & Philipp, M. T. Epitope mapping of the immunodominant invariable region of Borrelia burgdorferi VlsE in three host species. Infect. Immun. 68, 2349-2352 (2000).
33. Philipp, M. T. et al. Antibody response to IR6, a conserved immunodominant region of the VlsE lipoprotein, wanes rapidly after antibiotic treatment of Borrelia burgdorferi infection in experimental animals and in humans. J. Infect. Dis. 184, 870-878, doi: 10.1086/323392 (2001).
34. Bacon, R. M. et al. Serodiagnosis of Lyme disease by kinetic enzyme-linked immunosorbent assay using recombinant VlsE1 or peptide antigens of Borrelia burgdorferi compared with 2-tiered testing using whole-cell lysates. J. Infect. Dis. 187, 1187-1199, doi: 10.1086/374395 (2003).
35. Rhodes, D. R., Sanda, M. G., Otte, A. P., Chinnaiyan, A. M. & Rubin, M. A. Multiplex biomarker approach for determining risk of prostate-specific antigen-defined recurrence of prostate cancer. J. Natl. Cancer Inst. 95, 661-668 (2003).
36. Liang, F. T. et al. Antigenic conservation of an immunodominant invariable region of the VlsE lipoprotein among European pathogenic genospecies of Borrelia burgdorferi SL. J. Infect. Dis. 182, 1455-1462, doi: 10.1086/315862 (2000).
37. DeBiasi, R. L. A concise critical analysis of serologic testing for the diagnosis of lyme disease. Curr. Infect. Dis. Rep. 16, 450, doi: 10.1007/s11908-014-0450-9 (2014).