Systems and methods for molecular diagnostics
Inventors
Lei, Xiaojun • Yuan, Yuan • Xu, Qian • Fleming, Paul • Hayes, Ronan • Lewis, Brian • Richardson, Bruce
Assignees
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Publication Number
US-10427162-B2
Publication Date
2019-10-01
Expiration Date
Abstract
The present disclosure provides systems, devices and methods associates with processing and analyzing samples for molecular diagnostics. The system may process samples using assay cartridges including sample preparation modules and PCR modules. The system may include thermal cycler modules and optics modules to detect the specific nucleic acid sequences in the samples.
Core Innovation
The invention relates to a fully automated random-access molecular diagnostic device that uses an assay cartridge. The assay cartridge includes a sample preparation module and a PCR module, and the sample preparation module comprises an elongated body having an asymmetric sample loading well for loading a sample before nucleic acid is extracted. The sample loading well includes a generally vertical wall, a tilted cone shape bottom having a deepest portion, a sample loading well inlet covered by a removable cap, and a sample collecting channel with a sample loading well outlet at its top end and a fluid collecting area at its bottom end.
In the cartridge, the removable cap includes a cap inlet covered by a cap inlet septum having an inlet slit, and the sample loading well outlet is covered by a sample loading well outlet septum having an outlet slit. The fluid collecting area is arranged at the deepest portion of the bottom so that nucleic acid is collected from the fluid collecting area through the sample loading well outlet. The device further includes an automatic dispense system that uses a pipette to add the sample to the sample loading well through the sample loading well inlet and to collect nucleic acid via the sample loading well outlet.
The sample preparation module and the PCR module are detachably coupled, so the cartridge is interchangeably used within the automated random-access system. The described system includes an optics module for fluorescence detection using asynchronous multi-wavelength fluorescence detection over fiber termini, and cartridge interchangeability is supported by snap-coupled modules and cartridge marking, including barcode, RFID, direct reading electronic memory, or a dot code.
Claims Coverage
The independent claims cover two complementary aspects: a sample preparation module for a PCR-based molecular diagnostic device, and a complete assay cartridge including both the sample preparation module and a PCR module that is detachably coupled. Across the independent claims, the inventive structure is centered on the asymmetric, septum-sealed sample loading well and the pipette-driven loading and nucleic-acid collection to a deepest fluid-collecting area, followed by inclusion of a detachably coupled PCR module.
Asymmetric capped sample loading well for deepest fluid collection
An elongated body comprising a sample loading well of an asymmetric shape where a sample is loaded before nucleic acid is extracted, the sample loading well including a generally vertical wall around the sample loading well, a tilted cone shape bottom having a deepest portion, a sample loading well inlet covered by a removable cap, and a sample collecting channel having a sample loading well outlet at its top end and a fluid collecting area at its bottom end, with the fluid collecting area at the deepest portion of the bottom.
Septum-sealed inlet and outlet with slits for pipette routing
The removable cap has a cap inlet covered by a cap inlet septum having an inlet slit, and the sample loading well outlet is covered by a sample loading well outlet septum having an outlet slit.
Pipette-operated sample loading and nucleic-acid collection via the septums
The pipette is capable of adding the sample to the sample loading well through the sample loading well inlet and capable of collecting the nucleic acid from the fluid collecting area through the sample loading well outlet.
Detachably coupled PCR module in the assay cartridge
An assay cartridge comprising a PCR module, wherein the sample preparation module and the PCR module is detachably coupled.
Overall, the claim coverage centers on a sample preparation module with an asymmetric, septum-sealed loading well whose geometry routes material to a deepest fluid-collecting area for nucleic-acid collection by an automated pipette, and on an assay cartridge that includes a PCR module detachably coupled to that sample preparation module. Dependent claims further specify cartridge marking options and internal PCR module components and coupling structure.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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