Patent ID: 11891671
Assignee: A9.COM, INC.
Field: Measurement (Instruments)
Classification: CPC C  B  G | IPC B  C  G

Claim 0:
1. A system for detecting whether a target virus is present in a biological sample, the system comprising:
a cartridge comprising an outer shell, a swab tube slidably mounted within the outer shell, a lysis buffer container storing a lysis buffer, a virus detection assembly (VDA), and a control detection assembly (CDA); wherein the VDA comprises a VDA vacuum port, a VDA vacuum chamber fluidly connected to the VDA vacuum port, a VDA fluid displacement port, a VDA hydration water chamber storing hydration water and fluidly connected to the VDA fluid displacement port, a VDA lysis transfer tube fluidly connected to the swab tube, a VDA lysis well fluidly connected to the VDA lysis transfer tube, the VDA vacuum chamber, and the VDA hydration water chamber, a VDA amplification cycle well fluidly connected to the VDA lysis well and containing a VDA amplification cycle bead, a VDA detection cycle well fluidly connected to the VDA amplification cycle well and containing a VDA detection cycle bead, and a VDA fluorescence reading chamber fluidly connected to the VDA amplification cycle well; wherein the CDA comprises a CDA vacuum port, a CDA vacuum chamber fluidly connected to the CDA vacuum port, a CDA fluid displacement port, a CDA hydration water chamber storing hydration water and fluidly connected to the CDA fluid displacement port, a CDA lysis transfer tube fluidly connected to the swab tube, a CDA vacuum port, a CDA fluid displacement port, a CDA hydration water chamber storing hydration water, a CDA lysis transfer tube, a CDA lysis well fluidly connected to the CDA lysis transfer tube, the CDA vacuum chamber, and the CDA hydration water chamber, a CDA amplification cycle well fluidly connected to the CDA lysis well and containing a CDA amplification cycle bead, a CDA detection cycle well containing a CDA detection cycle bead, and a CDA fluorescence reading chamber fluidly connected to the CDA amplification cycle well; wherein the swab tube is configured to receive a portion of a swab on which a biological sample is disposed; and wherein the swab tube comprises a swab tube distal end configured to create an opening in the lysis buffer container during a user-induced distal sliding of the swab tube relative to the outer shell to create an opening in the lysis buffer container to release the cartridge is reconfigurable to a portion of the lysis buffer to contact the swab to form a sample infused lysis buffer solution;
an analysis device comprising a housing, a cartridge support assembly, a controller, a VDA vacuum pump, a VDA vacuum pump nozzle fluidly connected to the VDA vacuum pump, a VDA positive displacement pump, a VDA positive displacement pump nozzle fluidly connected to the VDA positive displacement pump, a CDA vacuum pump, a CDA vacuum pump nozzle fluidly connected to the CDA vacuum pump, a CDA positive displacement pump, a CDA positive displacement pump nozzle fluidly connected to the CDA positive displacement pump, a VDA lysis well heating element, a VDA reaction well heating element, a VDA detection well heating element, a CDA lysis well heating element, a CDA reaction well heating element, a CDA detection well heating element, a VDA light emitter, a VDA fluorescence light detector, a CDA light emitter, a CDA fluorescence light detector, a cartridge support configured to receive and accommodate the cartridge, wherein the cartridge support assembly is operable to operably couple the VDA vacuum pump nozzle to the VDA vacuum port, the VDA positive displacement pump nozzle to the VDA fluid displacement port, the CDA vacuum pump nozzle to the CDA vacuum port, the CDA positive displacement pump nozzle to the CDA fluid displacement port; and wherein the controller is configured to:
operate the VDA vacuum pump to draw a portion of the sample infused lysis buffer solution through the VDA lysis transfer tube from the swab tube to the VDA lysis well,
operate the CDA vacuum pump to draw a portion of the sample infused lysis buffer solution through the CDA lysis transfer tube from the swab tube to the CDA lysis well,
operate the VDA lysis well heating element to heat the sample infused lysis buffer solution in the VDA lysis well to within a VDA lysis temperature range for a VDA lysis period of time to form a VDA post-lysis sample solution;
operate the CDA lysis well heating element to heat the sample infused lysis buffer solution in the CDA lysis well to within a CDA lysis temperature range for a CDA lysis period of time to form a CDA post-lysis solution;
operate the VDA positive displacement pump to transfer the VDA post-lysis sample solution from the VDA lysis well and hydration water from the VDA hydration water chamber to the VDA amplification cycle well to rehydrate the VDA amplification cycle bead and form a VDA amplification cycle liquid in the VDA amplification cycle well;
operate the CDA positive displacement pump to transfer the CDA post-lysis solution from the CDA lysis well and hydration water from the CDA hydration water chamber to the CDA amplification cycle well to rehydrate the CDA amplification cycle bead and form a CDA amplification cycle liquid in the CDA amplification cycle well;
operate the VDA amplification well heating element to heat the VDA amplification cycle liquid in the VDA amplification cycle well to within a VDA amplification cycle temperature range for a VDA amplification cycle period of time to form a VDA amplified sample solution;
operate the CDA amplification well heating element to heat the CDA amplification cycle liquid in the CDA amplification cycle well to within a CDA amplification cycle temperature range for a CDA amplification cycle period of time to form a CDA amplified sample solution;
operate the VDA positive displacement pump to transfer the VDA amplified sample solution from the VDA amplification cycle well to the VDA detection cycle well to rehydrate the VDA detection cycle bead to form a VDA detection cycle liquid in the VDA detection cycle well;
operate the CDA positive displacement pump to transfer the CDA amplified sample solution from the CDA amplification cycle well to the CDA detection cycle well to rehydrate the CDA detection cycle bead to form a CDA detection cycle liquid in the CDA detection cycle well;
operate the VDA detection well heating element to maintain the VDA detection cycle liquid in the VDA detection cycle well within a VDA detection cycle temperature range for a VDA detection cycle period of time;
operate the CDA detection well heating element to maintain the CDA detection cycle liquid in the CDA detection cycle well within a CDA detection cycle temperature range for a CDA detection cycle period of time;
operate the VDA positive displacement pump to transfer the VDA detection cycle liquid from the VDA detection cycle well to the VDA fluorescence reading chamber;
operate the CDA positive displacement pump to transfer the CDA detection cycle liquid from the CDA detection cycle well to the CDA fluorescence reading chamber;
operate the VDA light emitter to emit a VDA fluorescence excitation light onto the VDA detection cycle liquid in the VDA fluorescence reading chamber so that the VDA fluorescence light detector generates a VDA fluorescence light emission detection signal in response to a VDA fluorescence light emitted by the VDA detection cycle liquid in the VDA fluorescence reading chamber;
operate the CDA light emitter to emit a CDA fluorescence excitation light onto the CDA detection cycle liquid in the CDA fluorescence reading chamber so that the CDA fluorescence light detector generates a CDA fluorescence light emission detection signal in response to a CDA fluorescence light emitted by the CDA detection cycle liquid in the CDA fluorescence reading chamber;
generate, based on the VDA fluorescence light emission detection signal and the CDA fluorescence light emission detection signal, detection data indicative of whether the target virus is present in the biological sample and/or whether the biological sample is sufficient for detecting whether the target virus is present in a biological sample; and
transmit the detection data to an electronic device via a communication connection for processing and/or communication to a user.