US 12,461,100 B2
Apparatus and method for detecting microbial contamination
Majed El-Dweik, Columbia, MO (US); and Elijah Sharpe, Columbia, MO (US)
Assigned to S D Systems, Inc., Columbia, MO (US)
Filed by S D Systems, Inc., Columbia, MO (US)
Filed on May 22, 2020, as Appl. No. 16/881,729.
Application 16/881,729 is a division of application No. 16/671,022, filed on Oct. 31, 2019, granted, now 11,150,244.
Application 16/671,022 is a continuation of application No. PCT/US2018/031679, filed on May 8, 2018.
Claims priority of provisional application 62/502,987, filed on May 8, 2017.
Claims priority of provisional application 62/503,147, filed on May 8, 2017.
Prior Publication US 2020/0355682 A1, Nov. 12, 2020
Int. Cl. G01N 33/569 (2006.01); C07K 16/12 (2006.01); G01N 33/541 (2006.01); G01N 33/543 (2006.01); G01N 33/577 (2006.01)
CPC G01N 33/56916 (2013.01) [C07K 16/1235 (2013.01); G01N 33/541 (2013.01); G01N 33/54326 (2013.01); G01N 33/54393 (2013.01); G01N 33/577 (2013.01)] 17 Claims
 
1. An automated apparatus for capture and quantitation of microbial contamination within a sample solution comprising a test sample, the apparatus comprising:
a plurality of sample containers comprising a plurality of Protein A-coated magnetic particles, wherein a capture antibody is linked to the Protein-A coating, wherein each of the plurality of sample containers is configured to receive a volume of the sample solution, to receive a volume of a detector antibody solution, and to transmit electromagnetic energy, wherein the detector antibody solution comprises a detector antibody linked to a fluorescent label, wherein the capture antibody and detector antibody specifically bind to a common antigen on the surface of a microbial contaminant at distinct sites when present in the sample solution, wherein the total volume of the sample solution and the detector antibody solution is within a range of 50 μL to 1.5 mL, and
a portable casing comprising an optical instrument, wherein the portable casing is light-proof;
wherein the optical instrument comprises:
a light source for providing illumination at a wavelength between 450 nm to 700 nm;
a photodetector for selectively detecting the energy of fluorescent light emitted by the fluorescent label and for generating an electrical signal corresponding to the detected energy, wherein the photodetector is configured to detect the energy of fluorescent light emitted by the detector antibody bound to the common antigen at a concentration of at least 1 cell microbial contaminant per 100 mL sample solution;
an amplifier for amplifying the electrical signal output;
a digital decoder for converting the amplified electrical signal output to a detectable signal,
a digital display configured to display a numeric value corresponding to a quantitative measure of the antigen, wherein the digital display is configured to correlate the detectable signal to a concentration of the contaminating microbe in the test sample; and
a sample holder comprising a plurality of sample container receiving positions oriented in a substantially circular or continuous loop, wherein each of the plurality of sample container receiving positions is configured to receive a respective one of the plurality of sample containers and project a magnetic field to manipulate the magnetic particles in the respective one, wherein the sample holder is motorized to move the respective one of the plurality from a first position in the optical instrument to a second position for illumination by the light source, wherein the second position is adjacent the photodetector.