Systems and methods for performing biological assays

Patent metadata

Field	Value
Publication number	US-12090482-B2
Application number	US-202117342533-A
Country	US
Kind code	B2
Filing date	Jun 8, 2021
Priority date	Mar 14, 2016
Publication date	Sep 17, 2024
Grant date	Sep 17, 2024

Abstract

Systems and methods for performing biological assays are provided herein. The systems and methods determine one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample. The nucleic acid amplification sample is reacted with an optical property modifying reagent in a reaction chamber of within a sample preparation device.

First claim

The invention claimed is:

1. A system for performing a biological assay, the system comprising:
a. a sample preparation device comprising:
i. a sample receiving module comprising a fluid container comprising a preparation solution, a first opening, and a second opening;
ii. a cap removably couplable to the sample receiving module, wherein coupling the cap to the sample receiving module seals the first opening; and
iii. a valve or a breakable seal operatively coupled to the sample receiving module so as to seal the second opening;

b. an optical property modifying device operatively couplable to the sample preparation device and comprising:
i. a sample receiving cartridge operatively coupled to the valve or the breakable seal comprising one or more reaction chambers each comprising an optical property modifying reagent;
ii. a substrate comprising a heating element; and
iii. a first sensor configured to detect the presence and/or absence of liquid in one or more of the reaction chambers and a control unit;
wherein when the optical property modifying device is operatively coupled to the sample preparation device and the valve is actuated from a sealed to unsealed conformation or the breakable seal is broken, the sample receiving module transmits at least a portion of the preparation solution through the valve or the breakable seal into the one or more reaction chambers, and wherein the first sensor, the control unit, and the heating element are operatively connected such that when liquid enters a reaction chamber, the first sensor senses the liquid and the heating element begins heating the reaction chamber automatically.

2. The system of claim 1 , wherein the cap further comprises a pressurizing component, wherein when the cap is operatively coupled to the sample receiving module, the pressurizing component of the cap pressurizes the sample receiving module, wherein when the optical property modifying device is operatively coupled to the sample preparation device and the valve is actuated from a sealed to unsealed conformation or the breakable seal is broken, the sample receiving module depressurizes by transmitting at least a portion of the preparation solution through the valve or the breakable seal into the one or more reaction chambers.

3. The system of claim 1 , wherein the cap comprises a first chamber, a plunger, a piercing member, and a breakable seal.

4. The system of claim 3 , wherein advancing the plunger pierces the breakable seal with the piercing member, thereby placing the first chamber and the fluid container in fluidic communication.

5. The system according to claim 1 , wherein the preparation solution is a nucleic acid amplification preparation solution.

6. The system according to claim 1 , wherein the substrate comprises a power source operatively connected to the heating element or a printed circuit board.

7. The system according to claim 1 , wherein the cap comprises a receptacle configured to receive an end of the sample receiving module therein when the cap is coupled to the sample receiving module.

8. The system according to claim 1 , wherein the sample preparation device and the optical property modifying device are each hand-held devices.

9. The system according to claim 1 , wherein the fluid container has a volume of 50 cm 3 or less.

10. The system according to claim 1 , further comprising a sample collector.

11. The system according to claim 1 , wherein the sample receiving module is shaped as a cylinder having a diameter of 5 cm or less and having a height of 20 cm or less.

12. The system according to claim 1 , wherein the fluid container has a volume ranging from 1 mL to 10 mL.

13. The system according to claim 1 , wherein the optical property modifying device further comprises an adhesive layer operatively connecting the sample receiving cartridge and the substrate and thereby forming a wall of each of the one or more reaction chambers.

14. The system according to claim 1 , wherein the sample receiving module is adapted to receive one or more portions of a sample collector.

15. The system according to claim 1 , wherein the sample receiving module comprises a first attachment element and the cap comprises a second attachment element operatively couplable with the first attachment element.

16. The system according to claim 1 , wherein the sample receiving module comprises an outer body forming a first chamber, and wherein the fluid container comprises a breakable seal and an inner body forming a second chamber, wherein the inner body is movable within the outer body.

17. A method of determining one or more characteristics of a nucleic acid amplification sample based on a modified optical property of the sample, the method comprising:
a. collecting a biological sample;
b. providing the system of claim 1 ;
c. inserting the biological sample comprising a nucleic acid into the preparation solution of the sample receiving module of the sample preparation device to produce a prepared nucleic acid amplification sample;
d. operatively coupling the sample preparation device with the optical property modifying device;
e. transmitting at least a portion of the prepared nucleic acid amplification sample out of the sample receiving module and into one or more reaction chambers of the optical property modifying device, wherein the chambers comprise an optical property modifying reagent and an amplification composition, and thereby generating a nucleic acid reaction mixture;
f. heating the reaction mixture with the heating element of the optical property modifying device, wherein the heating accelerates a nucleic acid amplification reaction comprising the nucleic acid and the amplification composition, the reaction generating an amplified nucleic acid and a plurality of protons;
g. reacting the protons with the optical property modifying reagent, wherein the reacting sufficiently modifies an optical property of the optical property modifying reagent to allow detection of the modified optical property; and
h. determining one or more characteristics of the sample based on the modified optical property.

Assignees

• Pfizer

Inventors

• Mitra Debkishore
• Myers Iii Frank B
• Waldeisen John Robert
• Dimov Ivan Krastev

Classifications

• B01L2400/0478

  pistons · CPC title

• C12Q1/6844

  Nucleic acid amplification reactions · CPC title

• B01L2400/0694

  vents used to stop and induce flow, backpressure valves · CPC title

• B01L2400/0683

  mechanically breaking a wall or membrane within a channel or chamber · CPC title

• B01L2400/0487

  fluid pressure, pneumatics · CPC title