Development of a 36-Channel Instrument for Assaying Biomarkers of Ultralow Concentrations Utilizing Immunomagnetic Reduction.

With the demands of the high-throughput assay of biomarkers of ultralow concentrations in clinics, a 36-channel instrument utilizing immunomagnetic reduction (IMR) has been developed. The instrument involves the use of a high- T c superconducting-quantum-interference-device (SQUID) magnetometer to detect the signals due to the associations between target biomarker molecules and the antibody-functionalized magnetic nanoparticles in the reagent of IMR. In addition to illustrating the design and the measurements of the instrument, the assay characterizations for eight kinds of biomarkers related to neurodegenerative disease are investigated. Furthermore, the assay results among three independent instruments were compared. For an instrument, the channel-to-channel variations in measured concentrations of biomarkers are within a range of 2.09 to 5.62%. The assay accuracy was found to be from 99 to 103.7%. The p values in measured concentrations for any of the tested biomarkers were higher than 0.05 among the three instruments. The results demonstrate high throughput, high stability, and high consistency for the SQUID-IMR instruments.