CAPSULE FOR LYOPHILIZED REAGENT STORAGE AND DELIVERY

• US 20190309344A1
• Filed: 04/10/2018
• Published: 10/10/2019
• Est. Priority Date: 04/10/2018
• Status: Active Grant

• Current Assignee: Stem Arts Projects, LLC
• Original Assignee: Stem Arts Projects, LLC
• Inventors: Oommen, Abraham, Piscatelli, Heather, Manning, Molly, Hangman, Alyssa
• Granted Patent: US 10,927,402 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 3/523 with means for closing or opening
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 1/6848 characterised by the means for preventing contamination or increasing the specificity or sensitivity of an amplification reaction

Abstract

A capsule to store and deliver lyophilized reagents is described. The lyophilized reagent capsule is configured to store a lyophilized reagent for at least five days, and is further configured to deliver a lyophilized reagent to a biological sample. The capsule includes a top, a bottom, and a lyophilized reagent. A method for delivering the lyophilized reagent via the capsule and without the use of pipettes to deliver the lyophilized reagents is described. The capsule may be part of a lyophilized reagent capsule kit.

Claims

1. A lyophilized reagent capsule to store and deliver lyophilized reagents, comprising:

a capsule configured to store a lyophilized reagent, the capsule comprising a top, a bottom, and the lyophilized reagent, wherein

the top is configured to receive the bottom to form an airtight seal and is from 6 to 13 millimeters in length, and wherein

the bottom is configured to be received by the top to form an airtight seal and is from 10 to 22 millimeters in length, and wherein

the lyophilized reagent is configured to be received by and reside within the capsule, and wherein

the lyophilized reagent is configured to complete a biological reaction.

3. The capsule of claim 1, wherein

The top has a radius from 4 to 9 millimeters, and wherein

The bottom has a radius from 4 to 9 millimeters.

4. The capsule of claim 3, wherein

The top and the bottom are gelatin.

5. The capsule of claim 3, wherein

The top and the bottom are hypromellose.

6. The capsule of claim 5, wherein

The lyophilized reagent is configured to complete deoxyribonucleic acid amplification by polymerase chain reaction amplification having fluorescence detection.

7. The capsule of claim 5, wherein,

The lyophilized reagent is configured to complete deoxyribonucleic acid amplification by rolling circle amplification with fluorescence detection.

8. The capsule of claim 5, wherein

The lyophilized reagent is configured to complete an immoassay by antigen detection.

17. The capsule of claim 3, wherein

The top and the bottom of the lyophilized reagent capsule are hypromellose, and wherein

The lyophilized reagents are configured to perform a biological reaction selected from the group consisting of deoxyribonucleic acid amplification by polymerase chain reaction amplification having fluorescence detection, deoxyribonucleic acid amplification by rolling circle amplification with fluorescence detection, an immoassay by antigen detection.

19. The kit of claim 17, wherein

The packaging is further configured to prevent light from reaching the lyophilized reagent.

2. The capsule of claim 2, wherein

The capsule is from 11 to 25 millimeters in length.

9. A method for performing a biological reaction with a lyophilized reagent capsule without the use of pipettes to deliver the lyophilized reagents, comprising:

Predetermining a sample to perform a biological reaction via a lyophilized reagent capsule, wherein

The lyophilized reagent capsule comprises a top, a bottom, and a lyophilized reagent configured to complete the biological reaction;

Delivering the lyophilized reagent to the sample to perform the biological reaction; and

Analyzing the completed biological reaction.

10. The method of claim 9, wherein

The delivering further comprises opening the lyophilized reagent capsule and depositing the lyophilized reagent in a reaction tube having the predetermined sample within ten minutes of opening the lyophilized reagent capsule.

11. The method of claim 9, wherein

The biological reaction is deoxyribonucleic acid amplification by polymerase chain reaction amplification having fluorescence detection.

12. The method of claim 10, wherein

The lyophilized reagent is configured to complete deoxyribonucleic acid amplification by rolling circle amplification with fluorescence detection.

13. The method of claim 10, wherein,

The lyophilized reagent is configured to complete an immoassay by antigen detection.

14. A lyophilized reagent capsule kit, comprising:

One or more lyophilized reagent capsules configured to store a lyophilized reagent, the one or more lyophilized reagent capsules comprising a top, a bottom, and the lyophilized reagent;

A packaging configured to store the one or more lyophilized reagent capsules;

Instructions configured to detail a method for using the one or more lyophilized reagent capsules.

15. The kit of claim 14, further comprising:

At least one reaction tube configured to receive the lyophilized reagent; and

A container configured to contain the at least one lyophilized reagent capsule, the packaging, the instructions, and the at least one reaction tube.

16. The kit of claim 15, wherein

The top and the bottom of the lyophilized reagent capsule are gelatin, and wherein

The lyophilized reagents are configured to perform a biological reaction selected from the group consisting of deoxyribonucleic acid amplification by polymerase chain reaction amplification having fluorescence detection, deoxyribonucleic acid amplification by rolling circle amplification with fluorescence detection, an immoassay by antigen detection.

18. The kit of claim 16, wherein

The packaging is further configured to minimize absorption of moisture by the lyophilized reagent capsule.