Sample transfer element and kit

Abstract

A sample transfer element 100 for transferring a sample from a first sample vessel 10 to a second sample vessel 20, comprising a first interface to engage with the first vessel and a second interface

Description

FIELD OF THE INVENTION The application relates to sample collection or storage kits, and more specifically to collection or storage kits which allows a user to transfer a sample without requiring additional or external handling of the sample, e.g. manual processes such as pipetting, liquid sample handling; or reagent mixing outside of the apparatus. BACKGROUND Traditional nucleic acid amplification requires a sample to be collected and manually processed through a laborious protocol of filtration, lysis, washing and elution to concentrate DNA from cells in the sample before mixing with PCR reagents, often requiring expensive technician time and laboratory infrastructure. There exists a need for a sample collection kit that integrates these processes to prepare a sample of for PCR in a single process, while maintaining conventional protocol of sample or target collection for PCR for both medical or non-medical uses. SUMMARY The application provides sample transfer elements and kits as set out in the attached claims. The sample transfer element may integrate filtration and / or reagent addition. The reagents may be PCR reagents and / or nucleic acid amplification reagents. The sample transfer element may be configured to dispensing a fixed volume of the sample into the second sample vessel. The second sample vessel may be compatible with standard PCR machines. The sample transfer element may be configured to engage with existing PCR target collection tubes. The sample transfer element may be configured as a cap. The cap may containing a filter and / or a reagent. The filter and / or the reagent may be fused within the cap. Alternatively, a reagent may form part of a sealant at an inlet or outlet, or within the sample transfer element. Preferably, the sample transfer element does not require external pressure or apparatus to function. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 schematically illustrates stages of using a kit comprising a sample transfer element, in an embodiment; Figure 2 provides photos and schematic illustrations of an embodiment; Figure 3 schematically illustrates a kit comprising a sample transfer element, in an embodiment. DETAILED DESCRIPTION Figure 1 is a conceptual drawing showing a single apparatus or single step sample collection or storage and processing kit for nucleic acid amplification and / or detection. At a first stage, a sample is collected using a first sample vessel. The first sample vessel may be a standard collection tube, such as a tube for samples containing nucleic acid. The first sample vessel may be initially capped or sealed as per general procedure, or may be left uncapped. A sample transfer element is then fitted to the first sample vessel. The sample transfer element may replace any cap that was previously applied to the first sample vessel. The sample transfer element may be configured as a cap or seal. The sample transfer element may comprise a filter. The sample transfer element may comprise one or more reagents. The sample transfer element may comprise a valved tube. A second sample vessel is fitted to an opposing side of the sample transfer element. The second sample vessel may be a vessel suitable for insertion in devices such as a PCR amplification system and / or a centrifuge. Inverting the sealed kit transfers a portion of the sample from the first sample vessel into the second sample vessel. The portion of the sample may have a fixed volume, where the volume is controlled by a valve of the sample transfer element and / or a valve of the second sample vessel. Inverting the sealed kit may also cause the portion of the sample to mix with reagent(s) and / or pass through a filter. Figure 2 shows one example application of the above-described sample transfer element and kit. Panel A is a photo of the collection kit in an embodiment. Panel B is a schematic illustration of the kit components in this embodiment. Panel C shows a kit according to this embodiment, arranged to position the second sample vessel in a nucleic acid amplification machine. In this example, the sample is a urine sample, as an example of human tissue collection. The sample is collected using a standard urine or human tissue collection space by the user. A standard seal or cap is then replaced with a sample transfer element according to the invention. The sample transfer element in this example is fitted with a filter, lyophilised reagents and a multi-valved PCR tube (figure 2A and 2B). Inverting the sealed kit filters the sample, dispenses a fixed volume (guided by valving) into a nucleic acid amplification, reaction or detection tube where it mixes with reagents in the tube. The tube and the overall kit is configured to fit directly into a nucleic acid amplification for detection device (figure 2C), entirely removing the need for manual sample (e.g. urine) handling. Figure 3 shows an example internal structure of a sample transfer element according to the invention. Referring to Figure 3, the sample transfer element 100 is configured as a cap or a sealing mechanism. An inner side of the cap / seal comprises an inlet 110 configured to receive a portion of a sample from a first sample vessel 10. The first sample vessel 10 and the sample transfer element 100 have complementary screw threads 11, 101 to hold the first sample vessel 10 together with the sample transfer element 100. The sample transfer element 100 may also have a sealing element on the inner side to reduce the risk of leakage between the first sample vessel 10 and the sample transfer element 100. The inlet 110 connects to an inner volume of the sample transfer element 100 in which a filter 130 and a reagent 140 are arranged. The filter 130 and the reagent 140 may be combined into a single element, for example by impregnating a filter material with a predetermined quantity of the reagent. The reagent may be configured as a lining or a seal, such that the sample flows past the reagent or breaks through the reagent as it is transferred through the sample transfer element 100. The inner volume also connects to an outlet 120 on an outer side of the cap. The outlet 120 is configured to engage with a second sample vessel 20. The sample transfer element 100 may also comprise a valve, such as a valve for controlling a volume of the portion of the sample that is transferred to the second sample vessel 20. The portion of the sample is preferably driven by gravity through the sample transfer element 100, when the kit is assembled and appropriately oriented.

Claims

1. A sample transfer element for transferring a sample from a first sample vessel to a second sample vessel, the sample transfer element comprising:a first interface configured to engage with the first sample vessel; anda second interface configured to engage with the second sample vessel.

2. A sample transfer element according to claim 1, configured as a cap for the first sample vessel.

3. A sample transfer element according to claim 2, wherein the cap comprises an inner face and an outer face, the inner face comprising an inlet for receiving liquid from the first sample vessel and the outer face comprising an outlet for delivering liquid to the second sample vessel.

4. A sample transfer element according to any of claims 1 to 3, wherein the first interface comprises an engagement element for holding the first sample vessel and / or for forming a sealed connection to the first sample vessel.

5. A sample transfer element according to claim 4, wherein the first interface comprises a screw thread for engaging with a corresponding screw thread of the first sample vessel.

6. A sample transfer element according to any of claims 1 to 5, comprising a mixing element configured to mix a reagent with the sample as the sample is transferred from the first sample vessel to the second sample vessel.

7. A sample transfer element according to any of claims 1 to 6, comprising a filter configured to filter the sample as the sample is transferred from the first sample vessel to the second sample vessel.

8. A sample transfer element according to claim 6 and claim 7, wherein the filter is the mixing element.

9. A sample transfer element according to any of claims 6 to 8, wherein the mixing element and / or the filter is replaceable.

10. A sample transfer element according to any of claims 1 to 9, wherein the sample transfer element is configured to transfer the sample under gravity.

11. A sample transfer element according to any of claims 1 to 10, further comprising a volume-controlling valve for controlling a volume of the sample transferred from the first sample vessel to the second sample vessel.

12. A kit comprising:a sample transfer element according to any of claims 1 to 11,a first sample vessel, anda second sample vessel.

13. A kit according to claim 12, wherein a volume of the first sample vessel is greater than a volume of the second sample vessel.

14. A kit according to claim 12 or claim 13, wherein the second sample vessel comprises a volume-controlling valve.

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