INTEGRATED NUCLEIC ACID ASSAYS
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Abstract
Integrated microfluidic cartridges for nucleic acid extraction, amplification, and detection from clinical samples are disclosed. The devices are single-entry, sanitary, and disposable. The devices enable simplex or multiplex nucleic acid target detection, as for example: assay panels for multiple infectious agents, or assay panels for cancerous cell types. Methods for use of microfluidic cartridges in a fully automated, pneumatically controlled apparatus are also disclosed.
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Citations
64 Claims
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1-37. -37. (canceled)
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38. An integrated microfluidic cartridge comprising:
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(a) a means for extracting nucleic acids from a biosample, comprising a first fluidic subcircuit for extracting nucleic acids from a biosample, said first fluidic subcircuit having a solid phase nucleic acid affinity binding substrate; (b) a means for synthesizing amplicons, comprising a second fluidic subcircuit for synthesizing amplicons; and (c) a means for detecting amplicons, comprising a third fluidic subcircuit having a detection chamber and an optical window, wherein said first, second and third fluidic subcircuits are formed in a single integrated disposable member, and wherein said first, second and third fluidic subcircuits are fluidly interconnected and are controllable by a plurality of internal pneumatic control elements comprising diaphragm-operated valves and bellows chambers, and wherein said plurality of internal pneumatic control elements are provided with pneumatic interconnect circuitry for connection to an external controllable pneumatic actuation manifold. - View Dependent Claims (39, 41)
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40. (canceled)
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42-54. -54. (canceled)
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55. An apparatus for performing a nucleic acid assay on a biological sample, said apparatus comprising:
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(a) a plastic disposable cartridge body containing dry and fluid reagents for said nucleic acid assay, wherein said cartridge body comprises; (i) a first fluidic subcircuit for extracting a nucleic acid from said sample; (ii) a second fluidic subcircuit for synthesizing an amplicon product; (iii) a third fluidic subcircuit for detecting said amplicon product; (iv) a sanitary waste collection chamber; and (v) a pneumatic interconnect subcircuit with arms for pneumatically actuating said first, second and third fluidic subcircuits; and (b) an off-cartridge pneumatic actuation manifold with arms and solenoid valves for supplying a programmable train of positive and negative pneumatic pressure pulses to said pneumatic interconnect subcircuit of said cartridge body under control of a microprocessor configured for controlling said nucleic acid assay. - View Dependent Claims (56, 57, 58, 59, 60, 61, 62, 63, 64)
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Specification