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1. WO2020223257 - MOLECULAR DIAGNOSTIC DEVICES WITH DIGITAL DETECTION CAPABILITY AND WIRELESS CONNECTIVITY

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[ EN ]

What is claimed is:

1. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed; a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of an assay signal indicating a presence of a target polynucleotide sequence within the biological sample; and an electronic system within the housing, the electronic system including a photodetector assembly, a memory, a processing device and a digital read module implemented in at least one of the memory or the processing device, the digital read module configured to:

receive, from the photodetector assembly, a first light signal for a first time period before the biological sample and a reagent are reacted within the detection volume;

determine a first magnitude associated with the first light signal during the first time period;

receive, from the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the assay signal;

determine a second magnitude associated with the second light signal during the second time period; and

determine, based on a comparison of the first magnitude and the second magnitude, whether the target polynucleotide sequence is present in the biological sample;

the electronic system configured to produce an electronic output when the target polynucleotide sequence is determined to be present in the biological sample.

2. The molecular diagnostic test device of claim 1, wherein:

the first magnitude is any one of a slope of the first light signal during the first time period or an average intensity of the first light signal during the first time period; and

the second magnitude is any one of a slope of the second light signal during the second time period or an average intensity of the second light signal during the second time period.

3. The molecular diagnostic test device of claim 1, wherein the electronic output is any one of a light output, an audible output, a wireless signal, or a haptic output.

4. The molecular diagnostic test device of claim 3, wherein:

the electronic system includes a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol; and

the electronic output including the wireless signal indicating the presence of the target polynucleotide sequence.

5. The molecular diagnostic test device of claim 3, wherein:

the housing defines a status opening; and

the electronic system includes a light output device configured to produce the light output, the light output being visible via the status opening.

6. The molecular diagnostic test device of claim 1, further comprising:

a reagent module within the housing, the reagent module containing the reagent separate from the detection module during the first time period; and

a valve within the housing,

the electronic system including a flow control module implemented in at least one of the memory or the processing device, the flow control module configured to produce a reagent signal to actuate the valve to cause the reagent to flow from the reagent module into the detection module.

7. The molecular diagnostic test device of claim 1, further comprising:

an amplification module within the housing, the amplification module including a reaction volume and a heater, the reaction volume configured to receive the biological sample, the heater configured to convey thermal energy into the reaction volume to amplify the target polynucleotide sequence; and

a pump within the housing, the pump configured to produce a flow of the biological sample from the amplification module to the detection module.

8 The molecular diagnostic test device of claim 1, wherein:

the assay signal is a first assay signal;

the reagent is formulated to facilitate production of a second assay signal indicating the presence of a reference polynucleotide sequence; and

the digital read module is further configured to:

receive, from the photodetector assembly, a third light signal for a third time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the third light signal associated with the second assay signal;

determine a third magnitude associated with the third light signal during the third time period; and

determine, based on a comparison of the second magnitude and the third magnitude, whether the target polynucleotide sequence is present in the biological sample.

9. The molecular diagnostic test device of claim 8, wherein:

the reference polynucleotide sequence comprises at least one of a control polynucleotide sequence or an invariant polynucleotide sequence associated with the target polynucleotide sequence.

10. The molecular diagnostic test device of claim 1, wherein:

the assay signal is a colorimetric signal;

the detection module includes a detection surface, the colorimetric signal being produced at the detection surface; and

the electronic system includes a light source, the light source configured to produce a first light beam through the detection module at the detection surface during the first time and a second light beam through the detection module at the detection surface during the second time, the first magnitude associated with a first attenuation of the first light beam, the second magnitude associated with a second attenuation of the second light beam.

11. The molecular diagnostic test device of claim 1, wherein:

the detection module includes a probe adhered to the detection surface, the probe designed to bind an amplicon associated with the target polynucleotide sequence, the colorimetric signal being produced from the detection surface.

12. A computer-implemented method of detecting the presence of a target polynucleotide sequence within a biological sample, the method performed by a molecular diagnostic test device including an electronic system and a detection module, the method comprising:

receiving, at a photodetector assembly of the electronic system, a first light signal for a first time period after the biological sample and a reagent are reacted within a detection volume of the detection module, the reagent formulated to facilitate production of a first assay signal and a second assay signal, the first assay signal indicating the presence of the target polynucleotide sequence, the second assay signal indicating the presence of a reference polynucleotide sequence, the first light signal associated with the first assay signal;

determining a first magnitude associated with the first light signal during the first time period;

receiving, at the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the second assay signal;

determining a second magnitude associated with the second light signal during the second time period; and

producing an electronic output when a comparison of the first magnitude and the second magnitude indicates that the target polynucleotide sequence is present.

13. The computer-implemented method of claim 12, wherein the comparison of the first magnitude and the second magnitude indicates that the target polynucleotide sequence is present when at least one of a difference between the first magnitude and the second magnitude is within a predetermined magnitude range or a ratio between the first magnitude and the second magnitude is within a predetermined ratio range.

14. The computer-implemented method of claim 12, wherein:

the first magnitude is any one of a slope of the first light signal during the first time period or an average intensity of the first light signal during the first time period; and

the second magnitude is any one of a slope of the second light signal during the second time period or an average intensity of the second light signal during the second time period.

15. The computer-implemented method of claim 12, wherein the determining the first magnitude, the determining the second magnitude, and the comparing of the first magnitude and the second magnitude are performed in a digital read module implemented in at least one of a memory or a processing device of the electronic system.

16. The computer-implemented method of claim 12, wherein:

the reference polynucleotide sequence comprises at least one of a control polynucleotide sequence or an invariant polynucleotide sequence associated with the target polynucleotide sequence.

17. The computer-implemented method of claim 12, wherein:

the first assay signal is any one of a colorimetric signal, a chemiluminescence signal, or a fluorescence signal.

18. The computer-implemented method of claim 12, wherein:

the detection module includes a first detection surface and a second detection surface; the first assay signal is a first colorimetric signal produced at the first detection surface, the first light signal being associated with a first light beam conveyed through the first detection surface, the first magnitude associated with a first attenuation of the first light beam; and

the second assay signal is a second colorimetric signal produced at the second detection surface, the second light signal being associated with a second light beam conveyed through the second detection surface, the second magnitude associated with a second attenuation of the second light beam.

19. The computer-implemented method of claim 18, wherein:

the determining the first magnitude, the determining the second magnitude, and the comparing of the first magnitude and the second magnitude are performed in a digital read module implemented in at least one of a memory or a processing device of the electronic system; and

the digital read module determines the presence of the target polynucleotide sequence based on at least one of a ratio of the second attenuation to the first attenuation or a difference between the second attenuation and the first attenuation.

20. The computer-implemented method of claim 18, wherein:

the detection module includes a first probe adhered to the first detection surface, the first probe designed to bind an amplicon associated with the target polynucleotide sequence; and

the detection module includes a second probe adhered to the second detection surface, the second probe designed to bind the amplicon associated with the reference polynucleotide sequence.

21. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed; a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of a colorimetric signal within the detection module after the biological sample and the reagent are reacted within the detection volume, the colorimetric signal indicating the presence of a target polynucleotide sequence within the biological sample; and

an electronic system within the housing, the electronic system including a light assembly, a photodetector assembly, a memory, a processing device and a digital read module implemented in at least one of the memory or the processing device,

the light assembly positioned on a first side of the detection module, the light assembly configured to produce a light beam that passes through detection volume of the detection module;

the photodetector assembly positioned on the first side of the detection module, the photodetector assembly configured to receive a light signal, the light signal associated with any of a reflection or an attenuation of the light beam; and

the digital read module configured to determine a magnitude of the light signal and produce, based on the magnitude, an indication whether the colorimetric signal is present in the detection volume.

22. The molecular diagnostic test device of claim 21, wherein:

the light signal is a first light signal;

the magnitude is a first magnitude; and

the digital read module is configured to:

receive, from the photodetector assembly, the first light signal for a first time period before the biological sample and a reagent are reacted within the detection volume;

determine the first magnitude associated with the first light signal during the first time period;

receive, from the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the colorimetric signal; and determine a second magnitude associated with the second light signal during the second time period; and

determine, based on a comparison of the first magnitude and the second magnitude, whether the colorimetric signal is present in the detection volume.

23. The molecular diagnostic test device of claim 21, wherein the electronic system is configured to produce any one of a light output, an audible output, a wireless signal, or a haptic output based on the indication whether the colorimetric signal is present in the detection volume.

24. The molecular diagnostic test device of claim 23, wherein:

the electronic system includes a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol; and

the electronic output including the wireless signal indicating the presence of the target polynucleotide sequence.

25. The molecular diagnostic test device of claim 21, wherein:

the detection module includes a detection flow cell and a heater, the detection flow cell defining the detection volume within which at least one of the biological sample or the reagent can be conveyed, the heater coupled to a surface of the detection flow cell on a second side of the detection module, the second side opposite the first side.

26. The molecular diagnostic test device of claim 25, wherein:

the detection flow cell includes a reflective portion on the second side of the detection module, the reflective portion configured to reflect the light beam produced by the light assembly positioned on the first side of the detection module back towards the photodetector assembly positioned on the first side of the detection module.

27. The molecular diagnostic test device of claim 26, wherein:

the detection flow cell includes a light-blocking portion on a third side of the detection module, the third side being nonparallel to the first side and the second side.

28. The molecular diagnostic test device of claim 25, wherein:

the colorimetric signal is a first colorimetric signal;

the light signal is a first light signal;

the magnitude is a first magnitude; and

the detection module includes a first detection surface and a second detection surface, the first colorimetric signal being produced at the first detection surface, the reagent formulated to facilitate production of a second colorimetric signal at the second detection surface after the biological sample and the reagent are reacted within the detection volume, the colorimetric signal indicating the presence of a reference polynucleotide sequence;

the light assembly is configured to produce a first light beam and a second light beam, the first light beam incident upon the first detection surface, the second light beam incident upon the second detection surface;

the photodetector assembly is configured to receive the first light signal and a second light signal, the first light signal associated with any of the reflection or the attenuation of the first light beam, the second light signal associated with any of a reflection or an attenuation of the second light beam; and

the digital read module is configured to determine a second magnitude of the second light signal.

29. The molecular diagnostic test device of claim 28, wherein:

the digital read module is configured to determine, based on a comparison of the first magnitude and the second magnitude, whether the first colorimetric signal is present at the first detection surface.

30. The molecular diagnostic test device of claim 28, wherein:

a first detection envelope is defined about the first detection surface, the first light beam and the first light signal each being within the first detection envelope; and

a second detection envelope is defined about the second detection surface, the second light beam and the second light signal each being within the second detection envelope;

the molecular diagnostic test device further comprising:

a light shield between the first detection envelope and the second detection envelope.

31. The molecular diagnostic test device of claim 30, wherein:

the housing defines a status opening;

the electronic system includes a light output device configured to produce a light output visible via the status opening; and

the light shield is a first light shield;

the molecular diagnostic test device further comprising:

a second light shield surrounding at least a portion of the light output device.

32. The molecular diagnostic test device of claim 28, wherein:

the digital read module is configured to cause production of the first light beam for a first time period and the second light beam for a second time period, the second time period different than the first time period.

33. The molecular diagnostic test device of claim 21, wherein:

the reagent is formulated to facilitate production of the colorimetric signal having a peak wavelength;

the light assembly is configured to produce the light beam having an emitted wavelength range that corresponds to the peak wavelength of the colorimetric signal; and

the photodetector assembly has a spectral sensitivity associated with the emitted wavelength range.

34. A computer-implemented method of detecting the presence of a colorimetric signal produced by a molecular diagnostic test device to indicate the presence of a target polynucleotide sequence within a biological sample, the method comprising:

receiving, at a photodetector of an electronic system of the molecular diagnostic test device, a first light signal for a first time period before the biological sample and a reagent are reacted within a detection volume of a detection module of the molecular diagnostic test device, the reagent formulated to facilitate production of the colorimetric signal within the detection volume, the colorimetric signal indicating the presence of the target polynucleotide sequence, the first light signal associated with a light beam conveyed through the detection module and into the detection volume;

determining a first slope of the first light signal during the first time period;

receiving, at the photodetector, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the light beam conveyed through the detection module and into the detection volume;

determining a second slope of the second light signal during the second time period; and producing an electronic output indicating the presence of the colorimetric signal when a slope difference between the first slope and the second slope exceeds a predetermined slope threshold.

35. The computer-implemented method of claim 34, wherein the determining the first slope and the determining the second slope is performed in a digital read module implemented in at least one of a memory or a processing device of the electronic system.

36. The computer-implemented method of claim 34, wherein the first light signal and the second light signal are each associated with an attenuation of the light beam through the detection volume of the detection module.

37. The method of claim 34, wherein the electronic output is any one of a light output, an audible output, a wireless signal, or a haptic output.

38. The method of claim 34, wherein:

the housing defines a status opening; and

the electronic output includes the light output, the light output being visible via the status opening.

39. The method of claim 34, wherein the molecular diagnostic test device is a stand-alone molecular diagnostic test device and the method of detecting is performed without any external instrument.

40. The computer-implemented method of claim 34, wherein:

the detection module includes a probe and a detection surface within the detection volume, the probe being adhered to the detection surface, the probe designed to bind an amplicon associated with the target polynucleotide sequence, the colorimetric signal being produced from the detection surface.

41. The computer-implemented method of claim 40, wherein the electronic system and the detection module are coupled within a housing of the molecular diagnostic test device, the electronic system includes a control module implemented in at least one of a memory or a processing device of the electronic system, the method further comprising:

producing sample flow signal to cause the biological sample to flow into the detection module, the probe binding the amplicon when the biological sample flows into the detection module; and

producing a reagent signal to cause the reagent to flow from a reagent module within the housing of the molecular diagnostic test device into the detection module.

42. The method of claim 40, wherein:

the detection surface is a first detection surface;

the colorimetric signal is a first colorimetric signal;

the probe is a first probe;

the photodetector is a first photodetector;

the light beam is a first light beam; and

the detection module includes a second probe adhered to a second detection surface within the detection module, the second probe designed to bind the amplicon associated with a reference polynucleotide sequence, a second colorimetric signal indicating the presence of the reference polynucleotide sequence being produced from the second detection surface when the biological sample and the reagent are reacted within the detection module;

the method further comprising:

receiving, at a second photodetector, a third light signal for the first time period, the third light signal associated with a second light beam conveyed through the detection module and into the detection volume; and

receiving, at the second photodetector, a fourth light signal for the second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the fourth light signal associated with the second light beam conveyed through the detection module and into the detection volume,

wherein the producing the electronic output indicating the presence of the first colorimetric signal is performed when a difference between a magnitude of the second light signal and the fourth light signal exceeds a predetermined magnitude threshold.

43. The method of claim 42, wherein the electronic output is a first electronic output, the method further comprising:

determining a third slope of the third light signal during the first time period; and determining a fourth slope of the second light signal during the second time period;

the producing a second electronic output indicating the presence of the second colorimetric signal when a slope difference between the third slope and the fourth slope exceeds the predetermined slope threshold.

44. The method of claim 42, wherein the first photodetector is the same as the second photodetector.

45. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed; a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of an assay signal within the detection module after the biological sample and the reagent are reacted within the detection volume, the assay signal indicating the presence of a target polynucleotide sequence within the biological sample; and

an electronic system within the housing, the electronic system including:

a sensor configured to produce a sensor signal associated with the assay signal; a digital read module implemented in at least one of a memory or a processing device, the digital read module configured to determine, based on at least one of an intensity of the sensor signal, a slope of the sensor signal, or a variability of the sensor signal, whether the assay signal is present in the detection volume; and

a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol, the radio sending a first wireless signal to establish a communications link between the computing device and the molecular diagnostic test device, the radio sending a second wireless signal indicating whether the assay signal is present.

46. A computer-implemented method, comprising:

establishing a communications link, via a short-range wireless protocol, between a mobile computing device and a molecular diagnostic test device, the molecular diagnostic test device including a housing, a detection module within the housing, a reagent within the housing, and an electronic system within the housing, the detection module defining a detection volume into which a biological sample can be conveyed, the reagent formulated to facilitate production of an assay signal within the detection module after the biological sample and the reagent are reacted within the detection volume, the assay signal indicating the presence of a target polynucleotide sequence within the biological sample, the electronic system including a sensor configured to produce a sensor signal associated with the assay signal;

receiving, from the electronic system of the molecular diagnostic test device, a first wireless signal associated with any one of a patient, an identifier associated with the molecular diagnostic test result, or the target polynucleotide sequence;

receiving, from the electronic system of the molecular diagnostic test device, a second wireless signal associated with the sensor signal; and

producing a test result notification based on the first wireless signal and the second wireless signal.

47. The computer-implemented method of claim 46, further comprising:

transmitting a third wireless signal associated with the test result notification, the third wireless signal indicating a location of the molecular diagnostic test device.

48. The computer-implemented method of claim 47, wherein the third wireless signal is devoid of information associated with a patient identity and includes information associated with at least one patient characteristic.

49. The computer-implemented method of claim 46, further comprising:

transmitting a third wireless signal to a first remote system, the third wireless signal including information associated with the presence of a target polynucleotide sequence within the biological sample and a patient identity; and

transmitting a fourth wireless signal to a second remote system, the fourth wireless signal including information associated with the presence of the target polynucleotide sequence within the biological sample and being devoid of information associated with a patient identity.

50. The computer-implemented method of claim 46, wherein the second wireless signal includes information associated with at least one of an intensity of the sensor signal, a slope of the sensor signal, or a variability of the sensor signal, the method further comprising:

determining based on the first wireless signal and the second wireless signal whether the target polynucleotide sequence is present within the biological sample.

51. The computer-implemented method of claim 46, wherein the producing the test result notification is performed by a first application that is executed by a processor of a mobile computing device, the method further comprising:

transmitting information associated with the presence of a target polynucleotide sequence within the biological sample and a patient identity to a second application executed by the processor of the mobile computing device; and

receiving, from the second application, a prescription information when the target polynucleotide sequence is present within the biological sample.

52. The computer-implemented method of claim 46, further comprising:

producing, in response to receiving the first wireless signal, an instruction for use associated with the molecular diagnostic test device.

53. The computer-implemented method of claim 46, wherein the instruction for use is a video instruction displayed by the mobile computing device, the instruction for use including a swab instruction for obtaining the biological sample from the patient.

54. The computer-implemented method of claim 46, wherein the producing the test result notification is performed by a first application that is executed by a processor of a mobile computing device, the method further comprising:

transmitting information associated with the first wireless signal to a second application executed by the processor of the mobile computing device; and

receiving, from the second application, an instruction for use associated with the molecular diagnostic test device.

55. The computer-implemented method of claim 54, wherein the second application is a telemedicine application.

56. The computer-implemented method of claim 55, further comprising:

receiving, from the second application, a validation code, the test result notification including an error message indicating an invalid test when the validation code is not received.