Localized diagnostic testing module

Patent metadata

Field	Value
Publication number	US-12220705-B2
Application number	US-202217703792-A
Country	US
Kind code	B2
Filing date	Mar 24, 2022
Priority date	Oct 12, 2021
Publication date	Feb 11, 2025
Grant date	Feb 11, 2025

Abstract

Systems and methods are disclosed for rapid PCR testing. Example embodiments may include a PCR testing module that includes a housing having a PCR machine disposed therein; a sample input station on the housing, wherein the sample input station is configured to receive a sample collection device (SCD) comprising a biological specimen sample provided by the patient; an SCD processing mechanism configured to transfer a lysed microportion of the biological specimen sample into a PCR sample tube attached to the SCD; at least one mechanism configured to separate the PCR sample tube from the SCD and transfer the PCR sample tube to the PCR machine; and a controller configured to (i) use the PCR machine to conduct a PCR test on contents of the PCR sample tube, and (ii) generate results of the PCR test.

First claim

That which is claimed is:

1. A PCR testing module, comprising:
a main cabinet comprising an enclosure that houses a PCR machine;
a patient interface disposed on an exterior of the main cabinet, the patient interface configured to accept input from a user;
a sample input station accessible at the exterior of the main cabinet, the sample input station being configured to receive a sample collection device (SCD) comprising a saliva sample;
a barcode scanner configured to read a barcode on the SCD;
an oven within the enclosure configured to thermally lyse the saliva sample in the SCD;
an SCD processing mechanism configured to transfer a lysed microportion of the saliva sample and water into a PCR sample tube that comprises a lyophilized master mix;
a sonicator configured to ultrasonically mix the lysed microportion of the saliva sample, the water, and the lyophilized master mix in the PCR sample tube attached to the SCD;
a robotic manipulator configured to (i) separate the PCR sample tube from the SCD and discard the SCD into a biohazard waste bin within the cabinet, (ii) seal the PCR sample tube to output a sealed PCR tube, and (iii) transfer the sealed PCR sample tube to the PCR machine; and
a controller configured to:
cause the PCR machine to conduct a PCR test on the contents of the PCR sample tube;
determine a result of the PCR test; and
provide results of the PCR test.

2. The PCR testing module of claim 1 , wherein the PCR machine comprises a continuous PCR system comprising:
a sample scanner configured to read a bar code on the PCR sample tube;
a conveyor system for moving a plurality of received PCR sample tubes through heating and cooling zones within the PCR machine; and
an array of laser diodes and photodetectors to detect the fluorescent intensity in each PCR sample tube,
wherein the conveyor system is configured to eject the PCR sample tube into the biohazard bin upon completion of testing.

3. The PCR testing module of claim 1 , wherein the main cabinet further comprises:
a disposal bay door for accessing the biohazard waste bin;
a maintenance access door for accessing an electrical cabinet;
a HEPA filter, and
an exhaust port configured to exhaust air from the enclosure after passing through the HEPA filter.

4. A testing module, comprising:
a housing having a PCR machine disposed therein;
an input station on the housing, wherein the input station is configured to receive a sample collection device (SCD) comprising a biological specimen sample;
an SCD processing mechanism configured to transfer a lysed microportion of the biological specimen sample into a PCR sample tube;
at least one mechanism configured to transfer the PCR sample tube to the PCR machine; and
a controller configured to cause the PCR machine to (i) conduct a PCR test on the contents of the PCR sample tube, and (ii) generate results of the PCR test.

5. The testing module of claim 4 , further comprising an input interface disposed on the housing, the input interface configured to accept input associated with conducting the PCR test.

6. The testing module of claim 4 , further comprising a first scanner configured to read a first machine-readable code on the SCD and a second scanner configured to read a second machine-readable code on the PCR sample tube.

7. The testing module of claim 4 , further comprising a heater configured to lyse the biological specimen sample in the SCD.

8. The testing module of claim 4 , further comprising a sonicator configured to ultrasonically mix the lysed microportion of the biological specimen sample with other materials in the PCR sample tube.

9. The testing module of claim 4 , further comprising a mechanism configured to separate the PCR sample tube from the SCD.

10. The testing module of claim 4 , further comprising:
a conveyor system configured to move a plurality of PCR sample tubes through heating and cooling zones within the PCR machine;
a sample scanner configured to read a machine-readable code on each of the plurality of PCR sample tubes; and
an array of laser diodes and photodetectors to detect the fluorescent intensity in each of the plurality of PCR sample tubes.

11. The testing module of claim 4 , further comprising:
a robotic manipulator configured to separate the biological specimen sample from a swab within the SCD.

12. The testing module of claim 4 , further comprising:
a sealing machine configured to apply a film or closure over an opening of the PCR sample tube.

13. The testing module of claim 4 , wherein the housing further comprises:
a biohazard bin positioned to receive the PCR sample tube upon completion of the PCR test; and
a disposal bay door for accessing the biohazard waste bin.

14. The testing module of claim 4 , wherein the housing further comprises:
a HEPA filter, and
an exhaust port configured to exhaust air from the housing after passing through the HEPA filter.

15. The testing module of claim 4 , wherein the PCR machine comprises a continuous PCR system.

16. The testing module of claim 15 , wherein the continuous PCR machine comprises:
a track;
a plurality of stationary thermal holders disposed along the track which are configured to expose the PCR sample tube to thermal cycles; and
a conveyor belt configured to convey the PCR sample tube among the plurality of stationary thermal holders.

17. The testing module of claim 16 , wherein the continuous PCR machine further comprises:
one or more sensors configured to detect fluorescent intensity in the PCR sample tube as the PCR sample tube undergoes thermal cycling; and
vacuum grippers configured to move the PCR sample tube to, along, and from the track.

18. The testing module of claim 4 , further comprising:
a user interface configured to accept payment for the test, to identify the user, and/or to output test results.

19. A testing module, comprising:
a housing having a PCR machine disposed therein;
an input station on the housing, wherein the input station is configured to receive a sample collection device (SCD) comprising a biological specimen sample;
a robotic manipulator configured to separate the biological specimen sample from a swab within the SCD;
an SCD processing mechanism configured to transfer a lysed microportion of the biological specimen sample into a PCR sample tube;
at least one mechanism configured to transfer the PCR sample tube to the PCR machine; and
a controller configured to cause the PCR machine to (i) conduct a PCR test on the contents of the PCR sample tube, and (ii) generate results of the PCR test.

20. The testing module of claim 19 , further comprising:
a first scanner configured to read a first machine-readable code on the SCD;
a second scanner configured to read a second machine-readable code on the PCR sample tube;
a mechanism configured to separate the PCR sample tube from the SCD; and
a sealing machine configured to apply a film or closure over an opening of the separated PCR sample tube.

Assignees

• Amazon Tech Inc

Inventors

• Farshi Jasmin B
• Zhang Pan
• Hirst Jonathan Barry
• Ziaie Babak
• Incze Bela
• Koraishy Babar M

Classifications

• B01L2300/1894

  Cooling means; Cryo cooling · CPC title

• B01L2300/1805

  Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks · CPC title

• B01L2300/0681

  Filter · CPC title

• B01L2300/0654

  Lenses; Optical fibres · CPC title

• B01L2300/0609

  Holders integrated in container to position an object · CPC title