Office Action 1: Notice of Allowance (2025-01-31)

CLAIMS:
CLAIMS

What is claimed is:

1\. A method for performing a PCR reaction using a PCR reaction system, the PCR reaction system comprising:
a sample containing unit having a pyrolysis freeze-dried powder and a sample provided provided therein, the sample containing unit comprising a first liquid outlet/inlet;
a diluent containing unit having a diluent provided therein, the diluent containing unit comprising a diluent outlet;
a PCR reaction unit having a freeze-dried powder of a reverse transcriptase and PCR raw
materials provided, the PCR reaction unit comprising a PCR reaction solution outlet and a pyrolyzed sample mixture inlet; and
a piston unit comprising an injection chamber and a piston, the injection chamber comprising a second liquid outlet/inlet, wherein the second liquid outlet/inlet is connected to the first liquid outlet/inlet through a
first pipeline, the second liquid outlet/inlet is connected to the diluent outlet through a second pipeline, the second liquid outlet/inlet is connected to the pyrolyzed sample mixture inlet through a third pipeline, and the PCR reaction solution outlet is connected to the diluent outlet through a fourth pipeline, the method comprising:
subjecting the piston to a first movement processing, to allow a part of the diluent to enter the injection chamber, wherein the diluent is provided in the diluent containing unit;
subjecting the piston to a second movement processing, to subject the part of the diluent entering the injection chamber, the pyrolysis freeze-dried powder, and the sample to a first mixing processing, wherein the pyrolysis freeze-dried powder and the sample are provided in
the sample containing unit, and the first mixing processing is performed in the sample containing unit;
subjecting a product of the first mixing processing to a pyrolysis processing, wherein the pyrolysis processing is performed in the sample containing unit; subjecting the piston to a third movement processing, to allow a product of the pyrolysis processing to enter the injection chamber;
subjecting the piston to a fourth movement processing, to subject the product of the pyrolysis processing entering the injection chamber and the remaining part of the diluent to a
second mixing processing, wherein the second mixing processing is performed in the diluent containing unit;
subjecting the piston to a fifth movement processing, to allow a product of the second mixing processing to enter the injection chamber;
subjecting the piston to a sixth movement processing, to subject the product of the second
mixing processing entering the injection chamber and the freeze-dried powder of the reverse transcriptase and the PCR raw materials to a third mixing processing, wherein the freeze-dried powder of the reverse transcriptase and the PCR raw materials is provided in the PCR reaction unit, and the third mixing processing is performed in the PCR reaction unit; and
subjecting a product of the third mixing processing to a PCR temperature cycle
amplification processing, wherein the PCR temperature cycle amplification processing is performed in the PCR reaction unit.

2\. The method according to claim 1, wherein the PCR temperature cycle amplification processing comprises:
subjecting the product of the third mixing processing to a constant temperature processing;
and subjecting a product of the constant temperature processing to a temperature cycle processing.

3\. The method according to claim 2, wherein the PCR reaction system further comprises:
a sample control valve provided on the first pipeline and configured to control a connection
state between the first liquid outlet/inlet and the second liquid outlet/inlet;
a dilution control valve provided on the second pipeline and configured to control a connection state between the diluent outlet and the second liquid outlet/inlet;
a first PCR control valve provided on the third pipeline and configured to control a connection state between the pyrolyzed sample mixture inlet and the second liquid outlet/inlet; and a second PCR control valve provided on the fourth pipeline and configured to control a connection state between the diluent outlet and the PCR reaction solution outlet, and
wherein the method further comprises:
prior to the first movement processing, closing the sample control valve, the first PCR
control valve, and the second PCR control valve, and opening the dilution control valve;
subsequent to the first movement processing and prior to the second movement processing, closing the dilution control valve and opening the sample control valve;
subsequent to the third movement processing and prior to the fourth movement processing, closing the sample control valve and opening the dilution control valve;
subsequent to the fifth movement processing and prior to the sixth movement processing, closing the dilution control valve, and opening the first PCR control valve and the second PCR control valve; and
subsequent to the constant temperature processing and prior to the temperature cycle processing, closing the first PCR control valve and the second PCR control valve.

4\. The method according to claim 3, wherein the PCR reaction system further comprises:
a buffering unit provided on the fourth pipeline and comprising a PCR reaction solution inlet and a vent, wherein the second PCR control valve is connected to the PCR reaction solution inlet, and the diluent outlet is connected to the vent.

5\. The method according to claim 1, wherein the PCR reaction system further comprises:
a sample containing unit seal provided on a surface of the first liquid outlet/inlet and configured to be used in a first sealing processing of the sample containing unit; and
a diluent containing unit seal provided on a surface of the diluent outlet and configured to be used in a second sealing processing of the diluent containing unit, and
wherein the method further comprises:
a pre-piercing processing comprising: subjecting the sample containing unit seal to a first piercing processing in advance, and subjecting the diluent containing unit seal to a second piercing processing in advance.

6\. The method according to claim 5, wherein the first piercing processing is performed by a piercing device for the sample containing unit seal, and the second piercing processing is performed by a piercing device for the diluent containing unit seal.
7\. The method according to claim 5, wherein at least one of the diluent containing unit seal and the sample containing unit seal is a sealing film.

8\. The method according to claim 7, wherein the sealing film is formed of at least one of a tin foil paper, a laminating film, or a kraft paper.

9\. The method according to claim 7, wherein the sealing film has a thickness ranging from 0.01 mm to 0.2 mm.

10\. The method according to claim 7, wherein the sealing film has a thickness ranging from 0.05 mm to 0.1 mm.

11\. A PCR reaction system, comprising:
a sample containing unit having a freeze-dried powder of pyrolysis raw materials and a sample provided therein, the sample containing unit comprising a first liquid outlet/inlet;
a diluent containing unit having a diluent provided therein, the diluent containing unit comprising a diluent outlet;
a PCR reaction unit having a freeze-dried powder of a reverse transcriptase and PCR raw
materials provided therein, the PCR reaction unit comprising a PCR reaction solution outlet and a pyrolyzed sample mixture inlet; and
a piston unit comprising an injection chamber and a piston, the injection chamber comprising a second liquid outlet/inlet, wherein the second liquid outlet/inlet is connected to the first liquid outlet/inlet through a
first pipeline, the second liquid outlet/inlet is connected to the diluent outlet through a second pipeline, the second liquid outlet/inlet is connected to the pyrolyzed sample mixture inlet through a third pipeline, and the PCR reaction solution outlet is connected to the diluent outlet through a fourth pipeline.

12\. The system according to claim 11, further comprising:
a sample control valve provided on the first pipeline and configured to control a connection state between the first liquid outlet/inlet and the second liquid outlet/inlet;
a dilution control valve provided on the second pipeline and configured to control a connection state between the diluent outlet and the second liquid outlet/inlet;
a first PCR control valve provided on the third pipeline and configured to control a
connection state between the pyrolyzed sample mixture inlet and the second liquid outlet/inlet; and a second PCR control valve provided on the fourth pipeline and configured to control a connection state between the diluent outlet and the PCR reaction solution outlet.

13\. The system according to claim 12, further comprising:
a buffering unit provided on the fourth pipeline and comprising a PCR reaction solution inlet and a vent, wherein the second PCR control valve is connected to the PCR reaction solution inlet, and the diluent outlet is connected to the vent.

14\. The system according to claim 11, further comprising:
a sample containing unit seal provided on a surface of the first liquid outlet/inlet and
configured to be used in a first sealing processing of the sample containing unit; and
a diluent containing unit seal provided on a surface of the diluent outlet and configured to be used in a second sealing processing of the diluent containing unit.

15\. The system according to claim 14, further comprising:
a piercing device for the sample containing unit seal, wherein the piercing device for the
sample containing unit seal is configured to be used in a first piercing processing of the sample containing unit seal; and
a piercing device for the diluent containing unit seal, wherein the piercing device for the diluent containing unit seal is configured to be used in a second piercing processing of the diluent containing unit seal.

16\. The system according to claim 14, wherein at least one of the diluent containing unit seal and the sample containing unit seal is a sealing film.

17\. The system according to claim 16, wherein the sealing film is formed of at least one of a tin foil paper, a laminating film, or a kraft paper.

18\. The system according to claim 16, wherein the sealing film has a thickness ranging from 0.01 mm to 0.2 mm, preferably, from 0.05mm to 0.1mm.

19\. The system according to claim 11, wherein the freeze-dried powder of the pyrolysis raw materials comprises a metal ion chelating agent, sodium dodecyl sulfate, saponin, proteinase K, polyethylene glycol 3350, Tris-HCl, and water;
the freeze-dried powder of the reverse transcriptase and the PCR raw materials comprises mannitol, sucrose, chloride salt, bovine serum albumin, dNTPs, polyoxyethylene lauryl ether, HEPES, DNA polymerase, reverse transcriptase, RNase inhibitor, and water;
preferably, the metal ion chelating agent is EDTA and EGTA; and
preferably, the chloride salt is potassium chloride and magnesium chloride.

20\. The system according to claim I1, wherein the diluent comprises polyol, chloride salt, Tris-HCl, surfactant, and water; and
optionally, the polyol is glycerol. 46 47 48 49 50 51 5 10 15 20 25 30

OFFICE ACTION:
DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Copies of Chinese Applications CN201921011114.0; CN201910591817.3; CN201910585250.9; CN201910591847.4; CN201910684842.6; CN201921682904.1; CN201910953740.X; CN201910954105.3; CN201910953826.2; and CN201910954116.1 have been filed with priority dates of 01 July 2019; 01 July 2019; 01 July 2019; 01 July 2019; 26 July 2019; 09 October 2019; 09 October 2019; 09 October 2019; 09 October 2019; and 09 October 2019 respectively.
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Michael Wiersch on 17 January 2025.
The application has been amended as follows:
Claim 1. (Currently Amended) A method for performing a PCR reaction using a PCR reaction system, the PCR reaction system comprising:
a sample containing unit having a pyrolysis freeze-dried powder and a sample provided
a diluent containing unit having a diluent provided therein, the diluent containing unit comprising a diluent outlet;
a PCR reaction unit having a freeze-dried powder of a reverse transcriptase and PCR raw materials provided, the PCR reaction unit comprising a PCR reaction solution outlet and a pyrolyzed sample mixture inlet; and
a piston unit comprising an injection chamber and a piston, the injection chamber comprising a second liquid outlet/inlet,
wherein the second liquid outlet/inlet is connected to the first liquid outlet/inlet through a first pipeline, the second liquid outlet/inlet is connected to the diluent outlet through a second pipeline, the second liquid outlet/inlet is connected to the pyrolyzed sample mixture inlet through a third pipeline, and the PCR reaction solution outlet is connected to the diluent outlet through a fourth pipeline,
the method comprising:
subjecting the piston to a first movement processing, to allow a part of the diluent to enter the injection chamber, wherein the diluent is provided in the diluent containing unit;
subjecting the piston to a second movement processing, to subject the part of the diluent entering the injection chamber, the pyrolysis freeze-dried powder, and the sample to a first mixing processing, wherein the pyrolysis freeze-dried powder and the sample are provided in the sample containing unit, and the first mixing processing is performed in the sample containing unit;
subjecting a product of the first mixing processing to a pyrolysis processing, wherein the pyrolysis processing is performed in the sample containing unit;
subjecting the piston to a third movement processing, to allow a product of the pyrolysis processing to enter the injection chamber;
subjecting the piston to a fourth movement processing, to subject the product of the pyrolysis processing entering the injection chamber and the remaining part of the diluent to a second mixing processing, wherein the second mixing processing is performed in the diluent containing unit;
subjecting the piston to a fifth movement processing, to allow a product of the second mixing processing to enter the injection chamber;
subjecting the piston to a sixth movement processing, to subject the product of the second mixing processing entering the injection chamber and the freeze-dried powder of the reverse transcriptase and the PCR raw materials to a third mixing processing, wherein the freeze-dried powder of the reverse transcriptase and the PCR raw materials is provided in the PCR reaction unit, and the third mixing processing is performed in the PCR reaction unit; and
subjecting a product of the third mixing processing to a PCR temperature cycle amplification processing, wherein the PCR temperature cycle amplification processing is performed in the PCR reaction unit.
Claim 18. (Currently Amended) The system according to claim 16, wherein the sealing film has a thickness ranging from 0.01 mm to 0.2 mm
Claim 19. (Currently Amended) The system according to claim 11, wherein the freeze-dried powder of the pyrolysis raw materials comprises a metal ion chelating agent, sodium dodecyl sulfate, saponin, proteinase K, polyethylene glycol 3350, Tris-HCl, and water; and
the freeze-dried powder of the reverse transcriptase and the PCR raw materials comprises mannitol, sucrose, chloride salt, bovine serum albumin, dNTPs, polyoxyethylene lauryl ether, HEPES, DNA polymerase, reverse transcriptase, RNase inhibitor, and water[[;]]
Claim 20. (Currently Amended) The system according to claim 11, wherein the diluent comprises polyol, chloride salt, Tris-HCl, surfactant, and water
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: the closest prior art to the instant application is United States Patent Application Publication US 2003/0162304 to Dority et al. (herein Dority) (X Reference on European Search Report) as cited on the 11/29/22 IDS and Chinese Publication CN109661273A to Briones et al. (herein Briones) (see machine translation provided).
Dority discloses a PCR reaction system and method for performing a PCR reaction, wherein the PCR reaction system comprises a sample containing unit 460 having a sample provided therein, the sample containing unit comprising a first liquid outlet/inlet; a diluent containing unit 470 having a diluent provided therein, the diluent containing unit 470 comprising a diluent outlet; a reagent chamber 478 comprising PCR raw materials; a PCR reaction unit 418 comprising a PCR reaction solution outlet and a sample mixture inlet; and a piston unit 416 comprising an injection chamber 450 and a piston 454, the injection chamber comprising a second liquid outlet/inlet, wherein the second liquid outlet/inlet is connected to the first liquid outlet/inlet through a first pipeline (440, 430, 438), the second liquid outlet/inlet is also connected to the diluent outlet through the first pipeline, the second liquid outlet/inlet is connected to the sample mixture inlet through a third pipeline (484, 486), and the PCR reaction solution outlet is also connected to the reagent chamber outlet through the first pipeline, wherein fluid passes from the diluent containing unit 470 through the diluent outlet, the first pipeline, and the second liquid outlet/inlet into the injection chamber, back through the second liquid outlet/inlet and first chamber into the reagent chamber 478, and through the sample mixture inlet into the third pipeline connected to the PCR reaction solution outlet, the method comprising: (i) subjecting the piston to a first movement processing, to allow a fluid sample from the sample containing unit 460 to enter the injection chamber 450; subjecting the piston to a second movement processing, to allow the fluid sample from the injection chamber 450 to enter the diluent containing unit 470 and a first mixing processing wherein the sample and lysing fluid moves into the injection chamber 450 for mixing; subjecting the piston to a third movement processing, to allow the product of the first mixing processing to ender the injection chamber 450; subjecting the piston to a fourth movement processing, to allow the product of the first mixing processing to enter the reagent chamber 478; subjecting the piston to a fifth movement processing wherein said product is subjected to a third mixing processing by toggling the mixture between the injection chamber 450 and the reagent chamber 478; subjecting the piston to a sixth movement processing wherein said mixture is transferred to the PCR reaction unit 418 for nucleic acid ampflication and/or detection in a thermal reaction chamber (see [0097-0104]; Figs. 25-26).
Briones discloses a PCR reaction system and method for performing a PCR reaction comprising a sample containing unit 1200, a diluent containing unit 1260, a pyrolysis module 1300/4300 comprising a reagent for a lysis solution in the form of a lyophilized powder; a PCR reaction unit 1900 comprising the reverse transcriptase in the form of a lyophilized powder for mixing with the product of a second mixing process from the pyrolysis module; a piston unit 1400 for controlling flow of fluid through the device and a ampflication module configured to perform a thermal cycling operation (see Fig. 10; [0127-0174]).
Neither Dority nor Briones, alone or in combination, teaches nor fairly suggests “a sample containing unit having a pyrolysis freeze-dried powder… the second liquid outlet/inlet is connected to the diluent outlet through a second pipeline, … the PCR reaction solution outlet is connected to the diluent through a fourth pipeline” as recited in instant independent claims 1 and 11 or  “ … subject the part of the diluent entering the injection chamber, the pyrolysis freeze-dried powder, and the sample to a first mixing processing, … wherein the first mixing processing is performed in the sample containing unit … subjecting a product of the first mixing processing to a pyrolysis processing, wherein the pyrolysis processing is performed in the sample containing unit; …subject the product of the pyrolysis processing entering the injection chamber and the remaining part of the diluent to a second mixing processing, wherein the second mixing processing is performed in the diluent containing unit” as recited in instant independent claim 1. In other words, the cited prior art fails to disclose the recited configuration and thus all the method steps of the claimed invention. Dority discloses a piston unit that can be rotated to connect to various units of the PCR reaction system through a single pipeline and therefore there would be no reason to modify the device of Dority to comprise the multiple connections of the claimed invention. Nor is there a teaching or suggestion in either prior art for the mixing, pyrolysis, etc. to occur in the sample containing unit followed by another mixing step in a diluent containing unit.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion



CITED REFERENCE SUMMARIES: Ref CN109661273A: Claims:
a kind of molecular diagnosis test device comprising:
B. reverse transcription module is configured as receiving input sample, and includes heater, allows the reverse transcription module right
The input sample carries out reverse transcriptase reaction；And
C. module is expanded, is configured as receiving input sample, the amplification module defined reaction volume and include heater makes
Polymerase chain reaction (PCR) can be carried out to the input sample by obtaining the amplification module；And
D. detection module is configured as receiving output and a reagent, the reagent from the amplification module and is prepared for
It generates and indicates in the input sample there are the signal of target amplicon,
E. wherein the amplification module and the detection module are integrated in the shell, and wherein the molecular diagnosis is surveyed
It is hand-held that trial assembly, which is set,.
molecular diagnosis test device as described in claim 1, wherein the signal is non-fluorescence signal.
molecular diagnosis test device as described in claim 1, in which:
The signal is visible signal, the visible signal by the target amplicon there are characterized by relevant color；And
And
The detection module includes the detection surface for generating the visible signal, and the detection surface is limited via by the shell
Detection opening it is visible.
molecular diagnosis test device as described in claim 1, wherein the signal is visible signal, the visible signal with
The target amplicon there are relevant colors to be characterized, the reagent be configured to so that the visible signal keep exist
At least about 30 minutes.
molecular diagnosis test device as described in claim 1, further comprising: being placed in the shell and being configured
For to the power supply of the amplification module for power supply, the power supply includes the DC battery that nominal voltage is about 9V, and the power supply capacity is small
In about 1200mAh.
molecular diagnosis test device as described in claim 1, further comprising:
It is placed in the intracorporal power supply of the shell；And
The intracorporal reagent modules of the shell are placed in, the reagent modules include the sealed volume containing the reagent, the examination
Agent module includes reagent actuator, and the reagent actuator is configured as being moved to the from first position when the reagent actuator
When two positions by the reagent be transmitted to in the holding room of the detection module fluid coupling, when the reagent actuator is in
When the first position, the power supply and the amplification module are electrically isolated, when the reagent actuator is in the second position
When, the power supply is electrically coupled at least one of processor or the amplification module.
It is placed in the intracorporal sample input module of the shell, the sample input module includes ingress port, outlet port, described
Ingress port is configured as receiving the input sample；And
Sample actuator is configured as when the sample actuator is moved to the second position from first position, will be described defeated
Enter sample transmission by outlet port and by filter assemblies, the sample actuator is configured as protecting in the second position
Hold locking.
molecular diagnosis test device as claimed in claim 7, wherein when the sample actuator is in the second position, institute
Sample actuator is stated to be in a fixed position relative at least one of the amplification module or described detection module.
molecular diagnosis test device as claimed in claim 7, wherein the sample actuator is configured as from described
One position is irreversibly moved to the non-electronic actuator of the second position.
molecular diagnosis test device as described in claim 1, wherein the molecular diagnosis test device is configured as only making
It with primary, and is disposable.
a kind of equipment comprising:
Limit the shell of detection openingï¼
It is placed in the intracorporal reverse transcription module of the shell, the reverse transcription module includes mobile parts and heater, the flowing
Component limits reverse transcription flow path, which has the intake section for being configured as receiving sample, described to add
Hot device is fixedly coupled to the mobile parts, so that the heater and the amplification flow path intersect in multiple positionsï¼
It is placed in the intracorporal amplification module of the shell, the amplification module includes mobile parts and heater, the mobile parts
Amplification flow path is limited, which has the intake section for being configured as receiving sample, and the heater is fixed
Ground is coupled to the mobile parts, so that the heater and the amplification flow path intersect in multiple positionsï¼
Be placed in the intracorporal reagent modules of the shell, the reagent modules include matrix, the matrix be configured as by with target
The relevant signaling molecule of amplicon is catalyzed the generation of signal；And
Detection module, the detection module limit sense channel, the sense channel and it is described amplification flow path exit portion and
The reagent modules are in fluid communication, and the detection module includes the detection surface in the sense channel, the detection surface
Be configured as keeping the target amplicon, the detection module is placed in the shell so that the detection surface via
The detection opening of the shell is visible.
equipment as claimed in claim 11, wherein the amplification and/or reverse transcription flow path are serpentine flow paths,
And the heater is the linear heat device for being irreversibly coupled to the mobile parts.
equipment as claimed in claim 11, in which:
The amplification and/or reverse transcription flow path are serpentine flow pathsï¼
Heater is heater assembly, and it includes the first linear heater, the couplings of the first end for being coupled to the mobile parts
It is bonded to the third of the second linear heat device of the second end of the mobile parts, the central part for being coupled to the mobile parts
Linear heat device, the heater assembly are coupled via adhesive with the first side of the mobile parts.
equipment as claimed in claim 11, further comprises:
It is placed in the shell and is configured as the power supply to the heating installation power supply, the nominal voltage of the power supply is about
9VDC and capacity are less than about 1200mAh.
equipment as claimed in claim 11, further comprising:
It is detachably coupled to the power module of shell, the power module is about 9VDC comprising nominal voltage and capacity is less than about
The power supply of 1200mAh, when the power module is coupled to shell, the power module includes to be electrically coupled to the heater
Electronic circuit.
Nominal voltage is about 9VDC and capacity is less than about the power supply of 1200mAh；And
It is detachably coupled to the isolated part of the shell, when the isolated part is coupled to the shell, the power supply
It is electrically isolated with the heater, when the isolated part is removed from the shell, the power supply is electrically coupled with the heater,
The reagent modules comprising reagent actuator, the reagent actuator are configured as: when the reagent actuator is from
When one position is moved to the second position, the matrix is discharged into and is kept in room, when the reagent actuator is in described first
When position, the movement of the isolated part is restricted.
It is placed in the intracorporal power supply of the shell, the reagent modules include reagent actuator, are configured as causing when the reagent
When dynamic device is moved to the second position from first position, the matrix is discharged into and is kept in room, when the reagent actuator is in
When the first position, the power supply and the heater are electrically isolated, when the reagent actuator is in the second position,
The power supply is electrically coupled with the heater.
It is placed in the intracorporal controller of the shell, the controller, institute are realized at least one of memory or processor
Stating controller includes to be configured as generating thermal control module of the thermal control signal to adjust the output of the heater.
The signal is visible signal, the visible signal by there are characterized by the relevant color of the target amplicon；And
The width of the sense channel is at least about 4mm.
equipment as claimed in claim 11, wherein the shell includes to be configured around the detection opening at least
The masking part of a part, the masking part are configured as enhancing the visible of the detection surface by the detection opening
Property.
The reagent modules include the reagent for being prepared for generating the signal；And
The signal is non-fluorescence visible signal, the non-fluorescence visible signal with to there are the relevant colors of the target amplicon
It is characterized, the reagent of the preparation makes the visible signal keep existing at least about 30 minutes.
Sample preparation module is placed in the shell and is configured as receiving input sample, the sample preparation module
Include filter assembliesï¼
Reverse transcription module is placed in the shell and is configured as receiving the output from the sample preparation module,
The reverse transcription module includes mobile parts and heater, and the mobile parts limit reverse transcription flow path, the reverse transcription stream
Dynamic path has the intake section for being configured as receiving sample, and the heater is fixedly coupled to the mobile parts, so that
The heater and the amplification flow path intersect in multiple positionsï¼
Module is expanded, be placed in the shell and is configured as receiving the output from the reverse transcription module, it is described
Expanding module includes mobile parts and heater, and the mobile parts limit serpentine flow path, the heater and the stream
Dynamic component coupling, the amplification module are configured as carrying out polymerase chain reaction to the output from the sample preparation module
(PCR)；And
Detection module is placed in the shell and is configured for receiving the output from the amplification module,
Wherein the equipment is configured as disposable.
equipment as claimed in claim 22, wherein the detection module is configured as receiving a reagent, which is formulated
For generating, there are the colorimetric signals of target organism in the instruction input sample.
equipment as claimed in claim 22, further comprising:
Sample actuator, when the sample actuator is moved to the second position from first position, the sample actuator is matched
It is set to the power for generating and the input sample being transported through to the filter assemblies, the sample actuator is configured as second
Position keeps locking, and the sample actuator includes locking shoulder, which is configured as shell is matingly engaged one
Part is so that the sample actuator is maintained at the second position.
equipment as claimed in claim 22, wherein the sample preparation module fixed coupling is in the shell.
equipment as claimed in claim 22, wherein the detection module fixed coupling is in the shell and includes detection
Surface, which, which generates, indicates in the input sample there are the colorimetric signal of target organism, the detection surface via
The detection opening limited from the shell.
It is placed in the intracorporal fluid transmission module of the shell, the fluid transmission module limits an internal capacity, described in actuating
When fluid transmission module, the output of the sample preparation module is flowed in the internal capacity, the fluid transmission module quilt
It is configured to the output of the sample preparation module being transmitted to the amplification module from the internal capacity, the fluid transmits mould
Block fixedly and is fluidly coupled to the sample preparation module.
equipment as claimed in claim 27, wherein the fluid transmission module includes to be movably disposed on the inside
Plunger in volume, so that the output of the sample preparation module is transmitted to institute from the internal capacity by the movement of the plunger
State amplification module.
It is placed in the shell and is configured as the power supply to the amplification module for power supply, the capacity of the power supply is less than about
1200mAhã
equipment as claimed in claim 22, wherein the sample preparation module includes washing container, which contains
Gas scrubbing and liquid scrubbing, the sample preparation module are configured as the gas scrubbing and the liquid scrubbing in order
Filter assemblies are transported through, the equipment further comprises:
Actuator is washed, is configured as generating power when the washing actuator is moved to the second position from first position, make
In first time the gas scrubbing is transported through into the filter assemblies, and between first after the second time
The liquid scrubbing is transported through into the filter assemblies.
device as described in claim 1, wherein the liquid in mixing chamber can be heated to by the heating element of step (b)
20 DEG C to 100 DEG C of temperature.
device as claimed in claim 31, wherein the liquid in the mixing chamber can be heated to by the heating element
20 DEG C to 50 DEG C of temperature.
device as claimed in claim 31, wherein the liquid in the mixing chamber can be heated to by the heating element
85 DEG C to 95 DEG C of temperature.
device as claimed in claim 31, wherein the heating element can be under 20 DEG C to 50 DEG C of constant temperature by liquid
It is maintained in the mixing chamber.
device as claimed in claim 31, wherein the heating element can be under 85 DEG C to 95 DEG C of constant temperature by liquid
Keep described in mixing chamber.
device as claimed in claim 31, wherein the heating element can be at a constant temperature by liquid in the mixing chamber
The time of middle holding 0.1 to 24 hour.
device as claimed in claim 31, wherein the heating element can be at a constant temperature by liquid in the mixing chamber
The time of middle holding 0.1 to 1 hour.
device as claimed in claim 31, wherein the heating element can be at a constant temperature by liquid in the mixing chamber
The time of middle holding 1 second to 30 minutes.
device as claimed in claim 31, wherein the heating element can be at a constant temperature by liquid in the mixing chamber
The time of middle holding 1 second to 10 minutes.
device as described in claim 1, wherein the reverse transcription room of step (b) further comprises mixing chamber and serpentine channel.
device as claimed in claim 40, wherein the mixing chamber can accommodate the volume of 10ul to 10ml.
device as claimed in claim 41, wherein the mixing chamber can accommodate the volume of 10ul to 1ml.
device as claimed in claim 42, wherein the mixing chamber can accommodate the volume of 300ul.
device as claimed in claim 43, wherein the serpentine channel is configured to have a cross section, the transversal mask
There is the aspect ratio (channel height for making to allow to carry out effective thermal coupling with the fluid with the area maximum of heater contacts
Than width).
molecular diagnosis test device as described in claim 1, wherein described device is designed to carry out and analyze multiple
PCRã
molecular diagnosis test device as described in claim 1, wherein the reverse transcription module further comprises comprising reversing
Record the freeze-drying particle of enzyme and reagent.
molecular diagnosis test device as described in claim 1, wherein the reverse transcription module includes reagent chamber, the reagent
Reagent needed for reverse transcriptase and Reverse transcript polymerase chain reaction are contained in room.
molecular diagnosis test device as claimed in claim 47, wherein the reverse transcriptase and reagent are to be lyophilized granulated
Formula exists.
a kind of method for DNA preparation comprising:
(a) biological sample is obtained, which includes one or more biological entities comprising RNAï¼
(b) one or more of biological entities are captured on the filterï¼
(c) one or more of biological entities are eluted from the filter；And
(d) one or more of biological entities are cracked,
(e) biological entities of the cracking are incubated together with reverse transcriptase and enough reagents, to carry out reverse transcription reaction, from
And multiple DNA moleculars are prepared,
Wherein the method prepares the DNA molecular from one or more of biological entities in 10 minutes or shorter time,
Its quality is enough successfully to carry out polymerase chain reaction (PCR).
method as claimed in claim 49, wherein the filter is by two filtration modules at wherein the second filter membrane
Aperture of the aperture less than the first filter membrane.
method as claimed in claim 49 further comprises washing step, thus once being captured on the filter
The biological entities then use filter and biological entities described in air washing.
(a) biological sample comprising one or more biological entities is obtained, wherein the biological entities include RNAï¼
(b) one or more of biological entities are cracked, to therefrom discharge multiple RNA molecules；And
(c) reverse transcriptase reaction is carried out to the RNA molecule of the release, to generate multiple DNA moleculars,
Wherein the method extracts the nucleic acid molecules from one or more of biological entities in 5 minutes or shorter time,
Its quality is enough successfully to carry out polymerase chain reaction (PCR).
method as claimed in claim 52, wherein carrying out the method by hand-held device.
method as claimed in claim 52, wherein the quality for being enough successfully to carry out polymerase chain reaction includes passing through
The nucleic acid molecules expanded at least 70% efficiency that qPCR standard curve determines.
method as claimed in claim 52, wherein the method generation at least 100 Î¼ L contain the molten of the nucleic acid molecules
Liquid.
method as claimed in claim 52, wherein the method generation at least 300 Î¼ L contain the molten of the nucleic acid molecules
Liquid.
method as claimed in claim 52, wherein the method generation at least 500 Î¼ L contain the molten of the nucleic acid molecules
Liquid.
method as claimed in claim 52 further comprises capturing biological entities on the filter, and keep the biology real
Body and filter undergo air washing.
method as claimed in claim 58, wherein with the air washing institute for the certain volume for being enough to dry the filter
State biological entities.
method as claimed in claim 58, wherein the biological entities described in at least about air washing of 1.5mL.
a kind of device for being configured for method as claimed in claim 49, wherein described device includes:
(a) input port is configured as receiving the biological sample comprising one or more biological entitiesï¼
(b) holding tank is operably coupled to the input port,
(c) part is inactivated, and includes heating element；And
(d) output port.
device as claimed in claim 61 further comprises permanent ventilation opening.
device as claimed in claim 61, wherein the holding tank further comprises that can sense to deposit in the holding tank
In the electric probe of liquid.
device as claimed in claim 61, wherein inactivation room includes serpentine path.
a kind of method of DNA preparation comprising:
Biological sample comprising RNA is transmitted in the sample input module of molecular diagnosis test device；And
Activate the molecular diagnosis test device with:
(a) biological sample is cracked in cracking module,
(b) biological sample is tr
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