title: Microfluidics-based point-of-care test for serodiagnosis of Lyme Disease.
abstract: Currently, diagnostic testing for Lyme disease is done by determination of the serologic responses to Borrelia burgdorferi antigens, with the exception of the early localized phase of disease where diagnosis must be done clinically. Here, we describe the use of microfluidics technology to develop a multiplexed rapid lab-on-a-chip point of care (POC) assay for the serologic diagnosis of human Lyme disease. Following ELISA screening of 12 candidate antigens, we tested 8 on a microfluidic diagnostic system, called mChip-Ld, using a set of 60 serological samples. The mChip-Ld test, which can be performed in 15 minutes at the point of care, showed promising performance for detection of antibodies to B. burgdorferi using the PPO triplex test (rP100 + PepVF + rOspC-K, AUC of 0.844) compared to a gold-standard reference of culture confirmed clinical samples. The performance is comparable to the commonly used C6 peptide by lab-based ELISA. In addition, the mChip-Ld test showed promising performance for early-stage diagnosis of the disease using the antigen OspC-K (sensitivity and specificity of 84% and 92%, respectively; AUC of 0.877). Overall, this study underscores the potential of using microfluidics to aid the diagnosis of Lyme disease at the point of care.
authors.affiliation: Department of Biomedical Engineering, Columbia University, 351 Engineering Terrace, 1210 Amsterdam Avenue, New York, NY 10027, USA.
authors.forename: Samiksha
authors.initials: S
authors.lastname: Nayak
authors.affiliation: Department of Biomedical Engineering, Columbia University, 351 Engineering Terrace, 1210 Amsterdam Avenue, New York, NY 10027, USA.
authors.forename: Archana
authors.initials: A
authors.lastname: Sridhara
authors.affiliation: Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, 858 Madison Ave, Memphis, TN, 38163, USA.
authors.forename: Rita
authors.initials: R
authors.lastname: Melo
authors.affiliation: Immuno Technologies Inc, 20 South Dudley St, Memphis TN 38103, USA.
authors.forename: Luciana
authors.initials: L
authors.lastname: Richer
authors.affiliation: Department of Biomedical Engineering, Columbia University, 351 Engineering Terrace, 1210 Amsterdam Avenue, New York, NY 10027, USA.
authors.forename: Natalie H
authors.initials: NH
authors.lastname: Chee
authors.affiliation: Department of Biomedical Engineering, Columbia University, 351 Engineering Terrace, 1210 Amsterdam Avenue, New York, NY 10027, USA.
authors.forename: Jiyoon
authors.initials: J
authors.lastname: Kim
authors.affiliation: OPKO Diagnostics, LLC, 4 Constitution Way, Suite E, Woburn, MA, 01801, USA.
authors.forename: Vincent
authors.initials: V
authors.lastname: Linder
authors.affiliation: OPKO Diagnostics, LLC, 4 Constitution Way, Suite E, Woburn, MA, 01801, USA.
authors.forename: David
authors.initials: D
authors.lastname: Steinmiller
authors.affiliation: Department of Biomedical Engineering, Columbia University, 351 Engineering Terrace, 1210 Amsterdam Avenue, New York, NY 10027, USA.
authors.forename: Samuel K
authors.initials: SK
authors.lastname: Sia
authors.affiliation: Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, 858 Madison Ave, Memphis, TN, 38163, USA.|Immuno Technologies Inc, 20 South Dudley St, Memphis TN 38103, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Gomes-Solecki
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology; D025065:Borrelia burgdorferi / Q000276:immunology; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis*; D044085:Microfluidics / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D013997:Time Factors
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial