Amplification vessel

Abstract

The present disclosure provides a vessel system (100) (e.g., for use in an amplification and / or detection system) having a vessel (110) and a cap (120). The vessel has a proximal end portion (112) defining an opening and including a top flange (114), a distal end portion (116) defining a conical region, and a central portion (118) extending between the proximal end portion (112) and the distal end portion (116) and defining a cylindrical region. The cap has a proximal end portion (122) including a cap flange (124), and a distal end portion (126) including a first elastomeric gasket seal (128) and a second elastomeric gasket seal (130), wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange (114).

Description

[0001] AMPLIFICATION VESSEL

[0002] BACKGROUND

[0003] Cross-Reference To Related Applications

[0004] The application claims priority to U.S. Provisional Application No. 63 / 663,023, filed June 21, 2024, the contents of which is incorporated herein by reference in its entirety.

[0005] Field of the Disclosed Subject Matter

[0006] The presently disclosed subject matter relates to vessel systems, e.g., amplification vessels and caps, for use in methods and systems for the amplification and / or detection of nucleic acids.

[0007] Background

[0008] Screening of donated blood and plasma has an essential role in safeguarding supply of life-saving whole blood, plasma, platelets, red blood cells and blood products manufactured from whole blood or plasma. Such screening involves performing rapid, sensitive, and high-throughput nucleic acid testing (NAT) of biological samples, e.g., blood, serum, or plasma samples from donors and / or patients. For example, systems and methods capable of performing rapid, sensitive, and high-throughput nucleic acid testing can be found in PCT Publication WO 2022 / 232601, filed on April 29, 2022, and PCT Publication WO 2022 / 232550, filed April 29, 2022, each of which is incorporated by reference in its entirety. NAT screening can include amplification and detection systems and methods, which use amplification vessels loaded with reagents and / or enzymes for amplifying target nucleic acids, e.g., nucleic acids derived from one or more pathogens.

[0009] Due to the nature of the biological materials tested during NAT screening, as well as the need to provide accurate results with high sensitivity, the amplification vessels need to be tightly sealed to prevent leaks and minimize or reduce contamination during the amplification and / or detection process. Current amplification vessel designs do not always perform as required.

[0010] Thus, there is a need for vessel systems (e.g. , amplification vessel systems) with vessels and caps designed to provide accurate results for NAT while also preventing leaks and minimizing contamination. The present disclosure fulfills these and other needs.

[0011] SUMMARY

[0012] The present disclosure provides a vessel system having a vessel and a cap (e.g. , having an amplification vessel and cap). The vessel system can be for use in amplification and / or detection systems and / or methods. The vessel system can be for use in amplification systems and / or methods. The vessel system can be for use in detection systems and / or methods. The vessel system can be for use in amplification and detection systems and / or methods. As an example, the vessel has a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region. Additionally or alternatively, the cap has a proximal end portion including a cap flange, and a distal end portion including one or more elastomeric gasket seals. For example, the vessel can include a first elastomeric gasket seal and a second elastomeric gasket seal, wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the one or more elastomeric gasket seals, e.g., the first elastomeric gasket seal and the second elastomeric gasket seal, engages an interior wall of the central portion and the cap flange is seated within the top flange. Additionally or alternatively, the cap can include a primary portion and an overmold portion.

[0013] The present disclosure further provides a vessel system having a vessel and a cap (e.g., having an amplification vessel and cap). The vessel system can be for use in amplification and / or detection systems and / or methods. The vessel system can be for use in amplification systems and / or methods. The vessel system can be for use in detection systems and / or methods. The vessel system can be for use in amplification and detection systems and / or methods. As an example, the vessel has a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region. Additionally or alternatively, the cap has a primary portion including a cap flange, and / or an overmold portion including one or more elastomeric gasket seals. The elastomeric gasket seals can include a first elastomeric gasket seal and a second elastomeric gasket seal, wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the one or more elastomeric gasket seals, e.g., the first elastomeric gasket seal and the second elastomeric gasket seal, engages an interior wall of the central portion and the cap flange is seated within the top flange.

[0014] In accordance with the disclosed subject matter, the cap can be coupled to the vessel by a snap lock. Additionally or alternatively, the cap can be coupled to the vessel by a press fit. Additionally or alternatively, each of the one or more elastomeric gasket seals, e.g., the first elastomeric gasket seal and the second elastomeric gasket seal, seals against the interior wall of the central portion of the vessel when the cap is received within the opening of the proximal end portion of the vessel. The top flange of the vessel can include a horizontal flange and a vertical wall to define a cap-flange receiving region. The cap flange can be seated within the cap-flange receiving region when the cap is received within the opening of the proximal end portion of the vessel. The top surface of the cap flange can be flush with a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel. As another example, the top surface of the cap flange can sit below a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

[0015] In accordance with the disclosed subject matter, the distal end portion of the vessel can define a rounded end. The vessel and / or the primary portion of the cap can be polypropylene (PP), e.g., a medical-grade copolymer PP. Additionally or alternatively, the cap and / or the overmold portion of the cap can be an elastomeric polymer, e.g., silicone. Additionally or alternatively, the vessel and / or the primary portion of the cap can be polypropylene (PP) and the overmold portion of the cap can be an elastomeric polymer, e.g., silicone.

[0016] The cap flange can define a top opening, e.g., a cavity. Additionally or alternatively, the cavity can be configured to receive a structure, e.g., a support pin. The insertion of the structure can enable manipulation of the vessel, e.g., to mix a sample.

[0017] The present disclosure provides systems, e.g., for amplifying and / or detecting nucleic acids obtained from a sample, that use the disclosed vessel system (e.g., amplification vessel system). The present disclosure further provides methods for amplifying and / or detecting nucleic acids obtained from a sample, e.g., a biological sample obtained from a subject, that use the disclosed vessel system (e.g., amplification vessel system). Although methods for amplifying and / or detecting nucleic acids are described herein, the disclosed vessel system (e.g. , amplification vessel system) can be used to detect any suitable biomarker obtained from a sample, e.g., a biological sample obtained from a subject.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1A depicts a cross-sectional side view of an exemplary vessel and cap coupled together in accordance with the disclosed subject matter.

[0020] FIG. IB depicts a cross-sectional side view of an exemplary cap in accordance with the disclosed subject matter. FIG. 1C depicts a perspective view of an exemplary vessel and cap coupled together in accordance with the disclosed subject matter.

[0021] FIGs. 2A-2B depict perspective views of an exemplary vessel in accordance with the disclosed subject matter.

[0022] FIG. 2C depicts a side view of the vessel of FIGs. 2A-2B.

[0023] FIGs. 2D-2E depict cross-sectional side views of the vessel of FIGs. 2A-2B and a portion of the vessel of FIGs. 2A-2B, respectively.

[0024] FIG. 2F depicts a bottom view of the vessel of FIGs. 2A-2B.

[0025] FIG. 2G depicts a cross-sectional bottom view of the proximal end portion of the vessel of FIGs. 2A-2B.

[0026] FIG. 2H depicts a top view of the vessel of FIGs. 2A-2B.

[0027] FIG. 21 depicts a side view of the vessel of FIGs. 2A-2B.

[0028] FIG. 2J depicts a bottom perspective view of the vessel of FIGs. 2A-2B.

[0029] FIG. 2K depicts a cut-away perspective view of the vessel of FIGs. 2A-2B.

[0030] FIG. 3A depicts a perspective view of an exemplary cap in accordance with the disclosed subject matter.

[0031] FIG. 3B depicts a top view of the cap of FIG. 3 A.

[0032] FIG. 3C depicts a side view of the cap of FIG. 3 A.

[0033] FIG. 3D depicts a bottom view of the cap of FIG. 3 A.

[0034] FIG. 3E depicts a cut-away bottom perspective view of the cap of FIG. 3 A.

[0035] FIG. 3F depicts a cut-away perspective view of the cap of FIG. 3 A.

[0036] FIG. 3G depicts a bottom perspective view of the cap of FIG. 3 A. DETAILED DESCRIPTION

[0037] Reference will now be made in detail to the disclosed subject matter, examples of which are illustrated in the accompanying drawings. The structure and corresponding method of operation of the disclosed subject matter will be described in conjunction with the detailed description of the system.

[0038] The subject matter disclosed herein is directed to various methods and systems for providing a vessel system (e.g. , an amplification vessel system) for use in an amplification and / or detection system and method. For example, and not by way of limitation, the subject matter disclosed herein is directed to a vessel system (e.g. , an amplification vessel system) for use in an amplification and / or detection systems and / or methods having a vessel and a cap. The vessel has a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region. The cap has a proximal end portion including a cap flange, and a distal end portion including a first elastomeric gasket seal and a second elastomeric gasket seal. The cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

[0039] The subject matter disclosed herein is further directed to various methods and systems for providing a vessel system (e.g., an amplification vessel system) for use in an amplification and / or detection system and method. For example, and not by way of limitation, the subject matter disclosed herein is directed to a vessel system (e.g., an amplification vessel system) for use in an amplification and / or detection systems and / or methods having a vessel and a cap. The vessel has a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region. The cap has a primary portion including a cap flange, and an overmold portion including a first elastomeric gasket seal and a second elastomeric gasket seal. The cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

[0040] Referring to FIGs. 1-3 for purpose of illustration and not limitation, the present disclosure provides a vessel system (e.g., an amplification vessel system) 100 (e.g., for use in amplification and / or detection systems and methods) having a vessel 110 and a cap 120. As illustrated in FIGs. 2A-2D, vessel 110 has a proximal end portion 112 defining an opening and including a top flange 114, a distal end portion 116 defining a conical region, and a central portion 118 extending between the proximal end portion 112 and the distal end portion 116. The central portion 118 can define a cylindrical region. Although a conical region is described, the distal end portion 116 can be defined by any suitably shaped region, including for example, cylindrical, ovoidal or hemispherical.

[0041] As illustrated in FIGs. 3A and 3C, cap 120 has a proximal end portion 122 including a cap flange 124, and a distal end portion 126 including a first elastomeric gasket seal 128 and a second elastomeric gasket seal 130. As an example, as illustrated in FIG. 3G, the distal end portion 126 can include a sealing interface 162. The cap 120 can be shaped to be received within the opening of the proximal end portion 112 of the vessel 110 such that each of the first elastomeric gasket seal 128 and the second elastomeric gasket seal 130 engages an interior wall of the central portion 118 and the cap flange 124 is seated within the top flange 114. As an example, the first elastomeric gasket seal 128 and the second elastomeric gasket seal 130 can engage surfaces 150 and 148 (as illustrated in FIG. 2K), respectively. Such a configuration can make it difficult to remove the cap 120 from the vessel 110 once the cap 120 is seated within the vessel 110. This can help prevent unintentional opening of the vessel 110, which can help prevent unwanted contamination. For example, such a configuration can prevent unwanted contamination in a system for the amplification and / or detection of nucleic acids and / or during a method for the amplification and / or detection of nucleic acids.

[0042] Utilizing two elastomeric gasket seals 128, 130 can provide an improved seal between the cap 120 and vessel 110 as compared to a single seal. For example, the number of seals used can provide a tradeoff between quality of the seal between the cap 120 and vessel 110 and the difficulty of seating the cap 120 within the vessel 110. Accordingly, although the cap 120 is described with two elastomeric gasket seals 128, 130, any suitable number of elastomeric gasket seals can be used, for example, one, three, four or more seals, depending on specific requirements. Similarly, although the vessel 110 is described with two surfaces 150, 148, as illustrated in FIG. 2K, any suitable number of surfaces can be used, for example, one, three, four or more sections, corresponding to the number of elastomeric gasket seals of the cap.

[0043] In accordance with the disclosed subject matter, the distal end portion 126 of the cap can be formed by an overmold portion 140. The overmold portion 140 can include a first elastomeric gasket seal 128 and a second elastomeric gasket seal 130, that is molded onto the primary portion 138. As illustrated in FIG. IB, the overmold portion 140 is molded over the primary portion 138. Although described as a two-part element including the primary portion 138 and an overmold portion 140, the cap 120 can be formed of a single piece.

[0044] For purpose of illustration and not limitation, the cap 120 can be coupled to the vessel 110 by any suitable means, including but not limited to snap lock or press fit. Although specific coupling is described, the cap 120 can be coupled to the vessel 110 by any suitable means, including for example, friction fit, threading, or snapping, press on, heat stake tape, and / or PSA tape. Each of the first elastomeric gasket seal 128 and the second elastomeric gasket seal 130 can seal against the interior wall of the central portion 118 when the cap is received within the opening of the proximal end portion 112 of the vessel 110. As an example, the first elastomeric gasket seal 128 and the second elastomeric gasket seal 130 can engage surfaces 150 and 148 (as illustrated in FIG. 2K), respectively. Additionally or alternatively, the overmold portion 140 can seal against the interior wall of the central portion 118 when the cap is received within the opening of the proximal end portion 112 of the vessel 110.

[0045] For purpose of illustration and not limitation, the top flange 114 of the vessel 110 can include a horizontal flange 132 and a vertical wall 134 to define a cap-flange receiving region 136 (e.g., as illustrated in FIGs. 2A-2B). The cap flange 124 can be seated within the cap-flange receiving region 136 when the cap 120 is received within the opening of the proximal end portion 112 of the vessel 110. Bottom surface 154 of the cap flange 124 can be flat against horizontal flange 132 to ensure proper positioning and / or orientation of the cap. Similarly, side surface 158 of the cap flange 124 can be guided by the surface 164 of the vertical wall 134 to ensure proper positioning and / or orientation of the cap. A top surface of the cap flange 124 can be flush with a top surface of the vertical wall 134 when the cap 120 is received within the opening of the proximal end portion 112 of the vessel 110. Alternatively, the top surface of the cap flange 124 can be below the top surface of the vertical wall 134 when the cap 120 is received within the opening of the proximal end portion 112 of the vessel 110 (for example, as shown in FIG. 1A). As illustrated in FIG. 3B, the cap flange 124 can define a top opening 142, e.g., a cavity 142. The cavity 142 can be configured to receive a structure, such as a support pin. The insertion of the support pin can enable manipulation of the vessel. For example, the support pin can support the vessel and cap when a vortex mixer is applied to the bottom of the vessel, or the support pin can be used to mix the contents of the vessel and cap.

[0046] Fur purpose of illustration and not limitation, the disclosed features of the vessel 110 and cap 120 can enable functional positioning and orientation by a system, e.g., a system for performing NAT. As an example, as illustrated in FIGs. 2G-2H and 2J-2K, axial structures 146 can provide a reference frame for a system to position and / or orient the vessel 110. Additionally or alternatively, as illustrated in FIG. 2 J, the outer surface of the vertical wall 134 can provide a reference frame for a system to position and / or orient the vessel 110. Additionally or alternatively, as illustrated in FIG. 3F, the top surface 156 of the cap flange 124 and / or the inner surface 160 can provide a reference frame for a system to position and / or orient the cap 120. Additionally or alternatively, the top surface 152 of the vertical wall 134 and / or the top surface 156 of the cap flange 124 can provide a reference frame for a system to position and / or orient the vessel 110 and / or cap 120. As an example, top surfaces 152, 156 can provide a sealing surface for a suction cup that is used to position and / or orient the vessel 110 and / or cap 120. Although the use of a suction cup is described, the structures and / or surfaces of the vessel 110 and / or cap 120 can be manipulated by any suitable means, e.g., direct force, frictional force, suctional force.

[0047] As illustrated in FIGs. 2C-2D, the central portion 118 and / or the distal portion 116 of the vessel 110 can include an optics viewing area 144. As an example, the optics viewing area 144 can be used for any purpose that requires visualizing, e.g., taking a picture, or detecting a signal, e.g., fluorescence, from a sample in the vessel. For illustration, and not limitation, the optics viewing area 144 can be used to detect nucleic acids (e.g., detecting fluorescence from fluorescent probes bound to nucleic acids), conduct quality control, or any other function that requires visualizing or detecting a signal from a sample in the vessel. Additionally or alternatively, the central portion 118 of the vessel 110 comprises a material suitable for use by a detection system, e.g., a nucleic acid detection system (e.g., a nucleic acid detection system that detects one or more fluorescence signals). For example, central portion 118 comprises a transparent material. For purpose of illustration and not limitation, the distal end portion of the vessel 110 can define any suitable shape or configuration, including but not limited to a rounded end. The vessel 110 and cap 120 can be located in the same consumable tray in a system for performing NAT, e.g., a system that includes an amplification and / or detection system, to minimize space requirements.

[0048] For purpose of illustration and not limitation, the vessel 110 can include any suitable material, including but not limited to polypropylene (PP), e.g., medical-grade copolymer PP. The cap 120 can include any suitable material, including but not limited to an elastomeric material, e.g., silicone, and PP, e.g., medical-grade copolymer PP. Cap 120 can comprise a silicone polymer. Additionally or alternatively, the primary portion 138 of the cap 120 comprises PP, e.g., medical-grade copolymer PP, and / or the overmold portion 140 of the cap 120 comprises an elastomeric polymer, e.g., silicone, e.g., a silicone polymer. Additionally or alternatively, the vessel 110 comprises PP and the cap 120 comprises PP (e.g., a primary portion 138 of the cap 120) and an elastomeric polymer (e.g., the overmold portion 140 of the cap 120).

[0049] The present disclosure further provides systems that include the use of the disclosed vessel for amplifying and / or detecting nucleic acids (e.g., obtained from a sample, e.g., a biological sample, of a subject). For purpose of illustration and not limitation, a system of the present disclosure can include one or more vessels and / or caps (e.g., amplification vessels and caps) disclosed herein. Non-limiting examples of systems that include and / or use one or more vessels and / or caps of the present disclosure are disclosed in WO 2022 / 232601, the contents of which are incorporated by reference in its entirety.

[0050] The present disclosure further provides methods that include the use of the disclosed vessel for amplifying and / or detecting nucleic acids (e.g., obtained from a sample, e.g., a biological sample, of a subject). For purpose of illustration and not limitation, a method of the present disclosure includes providing a sample, e.g., a sample including nucleic acids (e.g., purified nucleic acids) and / or amplified nucleic acids, and performing a nucleic acid amplification and / or detection technique. Non-limiting examples of such amplification and detection techniques are disclosed in in WO 2022 / 232601, the contents of which are incorporated by reference in its entirety. For purpose of illustration and not limitation, the amplification technique is an isothermal amplification technique.

[0051] Although methods for amplifying and / or detecting nucleic acids are described herein, the disclosed vessel system (e.g. , amplification vessel system) can be used to detect any suitable biomarker obtained from a sample, e.g., a biological sample obtained from a subject. For example, but not by way of limitation, the disclosed vessel system can be used for samples that include protein biomarkers and / or used in a system and / or method for detecting a protein biomarker.

[0052] In addition to the disclosed subject matter claimed below, the disclosed subject matter is also directed to other aspects of the disclosed subject matter having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other aspects of the disclosed subject matter having any other possible combinations. Thus, the foregoing description of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to the aspects of the disclosed subject matter disclosed.

[0053] It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.

[0054] EXEMPLARY EMBODIMENTS

[0055] A. A vessel system, comprising: a vessel having a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region; and a cap having a proximal end portion including a cap flange, and a distal end portion including a first elastomeric gasket seal and a second elastomeric gasket seal; wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

[0056] Al. The vessel system of A, wherein the cap comprises a primary portion and an overmold portion.

[0057] A2. The vessel system of A or Al, wherein the cap is coupled to the vessel by a snap lock.

[0058] A3. The vessel system of A or Al, wherein the cap is coupled to the vessel by a press fit.

[0059] A4. The vessel system of any one of A- A3, wherein each of the first elastomeric gasket seal and the second elastomeric gasket seal seals against the interior wall of the central portion when the cap is received within the opening of the proximal end portion of the vessel.

[0060] A5. The vessel system of any one of A-A4, wherein the top flange of the vessel comprises a horizontal flange and a vertical wall to define a cap-flange receiving region. A6. The vessel system of A5, wherein the cap flange is seated within the cap-flange receiving region when the cap is received within the opening of the proximal end portion of the vessel.

[0061] A7. The vessel system of A6, wherein a top surface of the cap flange is flush with a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

[0062] A8. The vessel system of A6, wherein a top surface of the cap flange sits below a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

[0063] A9. The vessel system of any one of A-A8, wherein the distal end portion of the vessel defines a rounded end.

[0064] A10. The vessel system of any one of A-A9, wherein the vessel comprises polypropylene (PP).

[0065] Al l. The vessel system of any one of A1-A10, wherein the primary portion of the cap comprises PP.

[0066] Al 2. The vessel system of A10 or Al l, wherein the PP is a medical-grade copolymer PP.

[0067] A13. The vessel system of any one of A-A12, wherein the cap comprises an elastomeric polymer.

[0068] Al 4. The vessel system of any one of Al -Al 3, wherein the overmold portion of the cap comprises an elastomeric polymer.

[0069] A15. The vessel system of A13 or A14, wherein the elastomeric polymer comprises silicone.

[0070] Al 6. The vessel system of any one of A-A15, wherein the cap flange defines a top opening. Al 7. The vessel system of Al 6, wherein the top opening comprises a cavity.

[0071] A18. The vessel system of A17, wherein the cavity is configured to receive a pin.

[0072] B. A vessel system, comprising: a vessel having a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region; and a cap having a primary portion including a cap flange, and an overmold portion including a first elastomeric gasket seal and a second elastomeric gasket seal; wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

[0073] Bl. The vessel system of B, wherein the cap is coupled to the vessel by a snap lock.

[0074] B2. The vessel system of B, wherein the cap is coupled to the vessel by a press fit.

[0075] B3. The vessel system of any one of B-B2, wherein each of the first elastomeric gasket seal and the second elastomeric gasket seal seals against the interior wall of the central portion when the cap is received within the opening of the proximal end portion of the vessel.

[0076] B4. The vessel system of any one of B-B3, wherein the top flange of the vessel comprises a horizontal flange and a vertical wall to define a cap-flange receiving region.

[0077] B5. The vessel system of B4, wherein the cap flange is seated within the capflange receiving region when the cap is received within the opening of the proximal end portion of the vessel. B6. The vessel system of B5, wherein a top surface of the cap flange is flush with a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

[0078] B7. The vessel system of B6, wherein a top surface of the cap flange sits below a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

[0079] B8. The vessel system of any one of B-B7, wherein the distal end portion of the vessel defines a rounded end.

[0080] B9. The vessel system of any one of B-B8, wherein the vessel comprises polypropylene (PP).

[0081] BIO. The vessel system of any one of B-B9, wherein the primary portion of the cap comprises PP.

[0082] Bl l. The vessel system of B9 or BIO, wherein the PP is a medical-grade copolymer PP.

[0083] B12. The vessel system of any one of B-Bl 1, wherein the cap comprises an elastomeric polymer.

[0084] B13. The vessel system of any one of B-B12, wherein the overmold portion of the cap comprises an elastomeric polymer.

[0085] B14. The vessel system of B12 or B13, wherein the elastomeric polymer comprises silicone.

[0086] B15. The vessel system of any one of B-B14, wherein the cap flange defines a top opening.

[0087] Bl 6. The vessel system of Bl 5, wherein the top opening comprises a cavity.

[0088] Bl 7. The vessel system of Bl 6, wherein the cavity is configured to receive a pin. c. The vessel system of any one of A-B 17 for use in an amplification and / or detection system.

[0089] Cl. The vessel system of C, wherein the amplification system is a nucleic acid amplification system.

[0090] C2. The vessel system of C or Cl, wherein the detection system is a nucleic acid detection system.

[0091] D. The vessel system of any one of A-B17 for use in a method for amplifying and / or detecting nucleic acids obtained from a sample.

[0092] DI. The vessel system for use of D, wherein the sample is a biological sample obtained from a subject. The vessel system of any one of A-B17 for use in an amplification method.

[0093] El. The vessel of E, wherein the amplification method is a nucleic acid amplification method.

[0094] F. The vessel system of any one of A-B 17 for use in a detection method.

[0095] Fl. The vessel system of F, wherein the detection method is a nucleic acid detection method.

Claims

CLAIMS1. A vessel system, comprising: a vessel having a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region; and a cap having a proximal end portion including a cap flange, and a distal end portion including a first elastomeric gasket seal and a second elastomeric gasket seal; wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

2. The vessel system of claim 1, wherein the cap comprises a primary portion and an overmold portion.

3. The vessel system of claim 1 or claim 2, wherein the cap is coupled to the vessel by a snap lock.

4. The vessel system of claim 1 or claim 2, wherein the cap is coupled to the vessel by a press fit.

5. The vessel system of any one of claims 1-4, wherein each of the first elastomeric gasket seal and the second elastomeric gasket seal seals against the interior wall of the central portion when the cap is received within the opening of the proximal end portion of the vessel.

6. The vessel system of any one of claims 1-5, wherein the top flange of the vessel comprises a horizontal flange and a vertical wall to define a cap-flange receiving region.

7. The vessel system of claim 6, wherein the cap flange is seated within the cap-flange receiving region when the cap is received within the opening of the proximal end portion of the vessel.

8. The vessel system of claim 7, wherein a top surface of the cap flange is flush with a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

9. The vessel system of claim 7, wherein a top surface of the cap flange sits below a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

10. The vessel system of any one of claims 1-9, wherein the distal end portion of the vessel defines a rounded end.

11. The vessel system of any one of claims 1-10, wherein the vessel comprises polypropylene (PP).

12. The vessel system of any one of claims 2-11, wherein the primary portion of the cap comprises PP.

13. The vessel system of claim 11 or claim 12, wherein the PP is a medical-grade copolymer PP.

14. The vessel system of any one of claims 1-13, wherein the cap comprises an elastomeric polymer.

15. The vessel system of any one of claims 2-14, wherein the overmold portion of the cap comprises an elastomeric polymer.

16. The vessel system of claim 14 or claim 15, wherein the elastomeric polymer comprises silicone.

17. The vessel system of any one of claims 1-16, wherein the cap flange defines a top opening.

18. The vessel system of claim 17, wherein the top opening comprises a cavity.

19. The vessel system of claim 18, wherein the cavity is configured to receive a pin.

20. A vessel system, comprising: a vessel having a proximal end portion defining an opening and including a top flange, a distal end portion defining a conical region, and a central portion extending between the proximal end portion and the distal end portion and defining a cylindrical region; and a cap having a primary portion including a cap flange, and an overmold portion including a first elastomeric gasket seal and a second elastomeric gasket seal; wherein the cap is shaped to be received within the opening of the proximal end portion of the vessel such that each of the first elastomeric gasket seal and the second elastomeric gasket seal engages an interior wall of the central portion and the cap flange is seated within the top flange.

21. The vessel system of claim 20, wherein the cap is coupled to the vessel by a snap lock.

22. The vessel system of claim 20, wherein the cap is coupled to the vessel by a press fit.

23. The vessel system of any one of claims 20-22, wherein each of the first elastomeric gasket seal and the second elastomeric gasket seal seals against the interior wall of the central portion when the cap is received within the opening of the proximal end portion of the vessel.

24. The vessel system of any one of claims 20-23, wherein the top flange of the vessel comprises a horizontal flange and a vertical wall to define a cap-flange receiving region.

25. The vessel system of claim 24, wherein the cap flange is seated within the cap-flange receiving region when the cap is received within the opening of the proximal end portion of the vessel.

26. The vessel system of claim 25, wherein a top surface of the cap flange is flush with a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

27. The vessel system of claim 26, wherein a top surface of the cap flange sits below a top surface of the vertical wall when the cap is received within the opening of the proximal end portion of the vessel.

28. The vessel system of any one of claims 20-27, wherein the distal end portion of the vessel defines a rounded end.

29. The vessel system of any one of claims 20-28, wherein the vessel comprises polypropylene (PP).

30. The vessel system of any one of claims 20-29, wherein the primary portion of the cap comprises PP.

31. The vessel system of claim 29 or claim 30, wherein the PP is a medical-grade copolymer PP.

32. The vessel system of any one of claims 20-31 , wherein the cap comprises an elastomeric polymer.

33. The vessel system of any one of claims 20-32, wherein the overmold portion of the cap comprises an elastomeric polymer.

34. The vessel system of claim 32 or claim 33, wherein the elastomeric polymer comprises silicone.

35. The vessel system of any one of claims 20-34, wherein the cap flange defines a top opening.

36. The vessel system of claim 35, wherein the top opening comprises a cavity.

37. The vessel system of claim 36, wherein the cavity is configured to receive a pin.

38. The vessel system of any one of claims 1-37 for use in an amplification and / or detection system.

39. The vessel system of any one of claims 1-38 for use in a method for amplifying and / or detecting nucleic acids obtained from a sample.

40. The vessel system for use of claim 39, wherein the sample is a biological sample obtained from a subject.

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