title: Integration of an optical CMOS sensor with a microfluidic channel allows a sensitive readout for biological assays in point-of-care tests.
abstract: In this manuscript, a microfluidic detection module, which allows a sensitive readout of biological assays in point-of-care (POC) tests, is presented. The proposed detection module consists of a microfluidic flow cell with an integrated Complementary Metal-Oxide-Semiconductor (CMOS)-based single photon counting optical sensor. Due to the integrated sensor-based readout, the detection module could be implemented as the core technology in stand-alone POC tests, for use in mobile or rural settings. The performance of the detection module was demonstrated in three assays: a peptide, a protein and an antibody detection assay. The antibody detection assay with readout in the detection module proved to be 7-fold more sensitive that the traditional colorimetric plate-based ELISA. The protein and peptide assay showed a lower limit of detection (LLOD) of 200 fM and 460 fM respectively. Results demonstrate that the sensitivity of the immunoassays is comparable with lab-based immunoassays and at least equal or better than current mainstream POC devices. This sensitive readout holds the potential to develop POC tests, which are able to detect low concentrations of biomarkers. This will broaden the diagnostic capabilities at the clinician's office and at patient's home, where currently only the less sensitive lateral flow and dipstick POC tests are implemented.
authors.affiliation: Janssen Diagnostics BVBA, Beerse, Belgium. Electronic address: bvandors@its.jnj.com.
authors.forename: Bieke
authors.initials: B
authors.lastname: Van Dorst
authors.affiliation: Micronit Microfluidics, Twente, The Netherlands.
authors.forename: Monica
authors.initials: M
authors.lastname: Brivio
authors.affiliation: NXP Semiconductors, Nijmegen, The Netherlands.
authors.forename: Elfried
authors.initials: E
authors.lastname: Van Der Sar
authors.affiliation: Micronit Microfluidics, Twente, The Netherlands.
authors.forename: Marko
authors.initials: M
authors.lastname: Blom
authors.affiliation: Micronit Microfluidics, Twente, The Netherlands.
authors.forename: Simon
authors.initials: S
authors.lastname: Reuvekamp
authors.affiliation: Micronit Microfluidics, Twente, The Netherlands.
authors.forename: Simone
authors.initials: S
authors.lastname: Tanzi
authors.affiliation: NXP Semiconductors, Nijmegen, The Netherlands.
authors.forename: Roelf
authors.initials: R
authors.lastname: Groenhuis
authors.affiliation: NXP Semiconductors, Nijmegen, The Netherlands.
authors.forename: Adewole
authors.initials: A
authors.lastname: Adojutelegan
authors.affiliation: NXP Semiconductors, Nijmegen, The Netherlands.
authors.forename: Erik-Jan
authors.initials: EJ
authors.lastname: Lous
authors.affiliation: NXP Semiconductors, Leuven, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Frederix
authors.affiliation: Janssen Diagnostics BVBA, Beerse, Belgium.
authors.forename: Lieven J
authors.initials: LJ
authors.lastname: Stuyver
mesh_terms: D000906:Antibodies / Q000737:chemistry / Q000302:isolation & purification*; D001681:Biological Assay; D015374:Biosensing Techniques; D003124:Colorimetry / Q000379:methods; D006801:Humans; D008670:Metals / Q000737:chemistry; D046210:Microfluidic Analytical Techniques / Q000295:instrumentation / Q000379:methods*; D010087:Oxides / Q000737:chemistry; D010455:Peptides / Q000737:chemistry / Q000302:isolation & purification*; D000067716:Point-of-Care Testing; D011506:Proteins / Q000737:chemistry / Q000302:isolation & purification*; D012666:Semiconductors
chemical_list: D000906:Antibodies; D008670:Metals; D010087:Oxides; D010455:Peptides; D011506:Proteins
keywords: Beads; CMOS-based optical sensor; Immunoassays; Microfluidic