Method for pretreating specimen and method for assaying biological substance

摘要

This invention relates to an assay device and a method for pretreating a specimen containing a biologically-relevant substance and then assaying the biologically-relevant substance. Biologically-relevant substances used in the assay method include microorganisms, cells, viruses, nucleic acids, polysaccharides, proteins (including antigens, antibodies, chromoproteins, and enzymes), peptides, nucleic acids, and small molecules. This pretreatment method removes contaminants from the biologically-relevant substances using supports such as magnetic particles, gels, resins, membranes, and solid-phased reagents. Therefore, in the assay method the following steps are generally carried out (i) a pretreatment step of treating a specimen using one or more first supports and then one or more second supports, and (ii) the assay step carried out after the pretreatment step. In particular, the pretreatment method reduces false positives and false negatives in the assay.

主权项

1. A biologically-relevant substance assay device, comprising:
(a) a specimen holding portion in which a specimen is held; (b) a first holding portion in which magnetic particles for trapping a biologically-relevant substance from the specimen are held; (c) a second holding portion in which a reagent for detecting the biologically-relevant substance is held; and (d) a dispensing mechanism for dispensing the specimen into the specimen holding portion; wherein the specimen holding portion, the first holding portion, and the second holding portion are arranged in line and in the order according to the content of the treatment of the specimen and the biologically-relevant substance, and each of the first holding portion and the second holding portion includes a plurality of wells, each well being separated from adjacent wells by a well wall, wherein the device further comprises a dispensing position controller configured for controlling the position of the dispensing mechanism, a magnet configured for constraining the magnetic particles in a nozzle of the dispensing mechanism, and a magnetic field controller configured for managing the placement of the magnet to control the strength of the magnetic field provided to the nozzle of the dispensing mechanism, the dispensing position controller moves the dispensing mechanism in a perpendicular direction with respect to the line and in a horizontal direction parallel to the line, and the magnetic field controller moves the magnet in the horizontal direction parallel to the line, and wherein a tip portion of the nozzle has a pumping opening, at least one optical fiber configured for sending a trigger light and a lens for receiving light from the biologically-relevant substance.