System and method for conducting an assay

Patent metadata

Field	Value
Publication number	US-11279967-B2
Application number	US-202017036730-A
Country	US
Kind code	B2
Filing date	Sep 29, 2020
Priority date	Mar 14, 2013
Publication date	Mar 22, 2022
Grant date	Mar 22, 2022

Abstract

A system for performing a nucleic acid amplification assay that includes a receptacle holder formed from a thermally conductive material and having a receptacle well for receiving a lower portion of a vial; a thermal element for cycling the temperature of the receptacle holder; a signal detection module in optical communication with the receptacle well; and a robotic pipettor. The receptacle holder supports a capped vial having a plastic, opaque cap in a snap-fit with a single plastic vial containing a nucleic acid amplification reagent. An upper portion of the cap includes a probe recess that is configured to be removably engaged by an end of a probe of the robotic pipettor. A lower portion of the vial is contained within the receptacle well, and the cap is situated above a top surface of the receptacle holder.

First claim

The invention claimed is:

1. A system for performing a nucleic acid amplification assay, the system comprising:
a receptacle holder formed from a thermally-conductive material and comprising a receptacle well, wherein the receptacle well is configured to conform to an outer surface of a lower portion of a vial, and wherein the receptacle holder includes a through-hole extending from a bottom center of an inner surface of the receptacle well to a bottom outer surface of the receptacle holder;
a thermal element positioned proximal to the receptacle holder for altering a temperature of the receptacle holder;
a signal detection module in optical communication with the receptacle well via the through-hole of the receptacle well, wherein the signal detection module is configured to generate an excitation signal that is directed through the through-hole of the receptacle well and to detect an optical emission from a fluid contained in a vial supported by the receptacle well and through the through-hole of the receptacle well;
a capped vial comprising a cap and a vial containing a fluid comprising a sample and a nucleic acid amplification reagent; and
a robotic pipettor; comprising a probe configured to be inserted into the cap;
wherein the receptacle well supports the capped vial, the cap of the capped vial comprising an opaque cap in a snap-fit relationship with the vial containing the fluid comprising the sample and the nucleic acid amplification reagent, the cap and the vial each being a single piece of plastic, wherein an upper portion of the cap is situated above the vial and defines a probe recess, a rim at a top end of the cap and fully circumscribing the upper portion of the cap, the upper portion of the cap being configured for frictional engagement with an end of the probe of the robotic pipettor when the end of the probe is inserted into the probe recess;
wherein a lower portion of the vial is contained within the receptacle well, and
wherein the cap is situated above a top surface of the receptacle holder.

2. The system of claim 1 , wherein an outer surface of a lower portion of the cap of the capped vial is in sealing contact with an inner surface of an upper portion of the vial.

3. The system of claim 2 , wherein the vial comprises a lock collar and the cap comprises a corresponding latch collar, the latch collar including one or more locking members extending toward a lower portion of the cap, and wherein the one or more locking members are in inter-locking engagement with the lock collar.

4. The system of claim 1 , wherein the thermal element is positioned proximal to a side surface of the receptacle holder, and wherein the thermal element provides thermal energy through the receptacle holder to the receptacle well.

5. The system of claim 1 , wherein the thermal element is configured to cyclically vary the temperature of the receptacle holder.

6. The system of claim 1 , wherein the signal detection module comprises an excitation signal source and an emission signal detector, and the system further comprises at least one optical fiber comprising a first end and a second end, the first end of the at least one optical fiber being in optical communication with the receptacle well through the through-hole of the receptacle well, and the second end of the at least one optical fiber being in optical communication with at least one of the excitation signal source and the emission signal detector.

7. The system of claim 6 , wherein the excitation signal source is configured to generate an excitation signal at a predetermined wavelength.

8. The system of claim 7 , wherein the emission signal detector is configured to detect the optical emission signal by receiving an optical emission from the fluid contained in the vial and generating a voltage signal corresponding to an intensity of the received optical emission.

9. The system of claim 6 , wherein the second end of the at least one optical fiber is in optical communication with the excitation signal source and the emission signal detector.

10. The system of claim 6 , wherein the excitation signal source is configured to generate an excitation signal at a predetermined wavelength, and wherein the emission signal detector is configured to detect the optical emission signal by receiving an optical emission from the fluid contained in the vial and generating a voltage signal corresponding to an intensity of the received optical emission.

11. The system of claim 1 , wherein the system does not include a cover configured to move between a first position blocking access of the robotic pipettor to the capped vial and a second position allowing the robotic pipettor to access the capped vial.

12. The system of claim 1 , further comprising a centrifuge configured to receive the capped vial, wherein the robotic pipettor is configured to transfer the capped vial to a first location of the centrifuge when the end of the probe of the robotic pipettor is frictionally engaged with the upper portion of the cap.

13. The system of claim 12 , the robotic pipettor further comprising a vial transfer arm comprising the probe configured for frictional engagement with the upper portion of the cap when the probe is inserted into the probe recess, the vial transfer arm being further configured to transfer the capped vial from a second location of the centrifuge to the receptacle well, the first and second locations of the centrifuge being different locations.

14. The system of claim 12 , wherein the robotic pipettor is further configured to transfer the capped vial from a second location of the centrifuge to the receptacle well, the first and second locations of the centrifuge being different locations.

15. The system of claim 2 , wherein the vial comprises a pair of opposed latch hooks and the cap comprises a latch collar, the latch hooks in inter-locking engagement with the latch collar, where the latch collar is situated beneath the latch hooks.

16. The system of claim 15 , wherein the cap further comprises an annular collar and a lower portion situated beneath the annular collar, the lower portion of the cap being frictionally fit within the upper portion of the vial.

17. The system of claim 16 , wherein the lower portion of the cap comprises a plug having a closed end that extends into the upper portion of the vial.

18. The system of claim 17 , wherein the plug comprises a seal ring that is in contact with the inner surface of the upper portion of the vial, thereby providing the sealing contact.

19. The system of claim 16 , wherein the plug has a convex distal end surface.

20. The system of claim 1 , wherein the nucleic acid amplification reagent includes a polymerase and nucleoside triphosphates, and wherein the fluid further comprises a detection reagent including a detection probe having interacting labels, the interacting labels including an emission moiety and a quencher moiety.

21. The system of claim 20 , wherein the signal detection module is configured to periodically detect emissions from the emission moiety during a nucleic acid amplification reaction performed in the fluid contained in the capped vial.

22. The system of claim 21 , wherein the emission moiety is a fluorescent moiety.

23. The system of claim 3 , wherein the cap further comprises a lower portion having a closed lower end, the closed lower end defining a plug that extends into the upper portion of the vial, and wherein an annular rib on an outer surface of the pl

Assignees

• Gen Probe Inc

Inventors

• Buse David A
• Combs David Howard
• Knight Byron J
• Hagen Norbert D
• Opalsky David
• Rhubottom Jason F
• Moravick Keith
• Moore Tyler
• Prasad Anita
• Richardson Bruce

Classifications

• B01L3/50825 Primary

  Closing or opening means, corks, bungs · CPC title

• B01L2200/026

  Fluid interfacing between devices or objects, e.g. connectors, inlet details · CPC title

• B01L2200/0689

  Sealing · CPC title

• B01L3/565

  Seals · CPC title

• C12Q1/6806 Primary

  Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence) · CPC title