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Punch Device & Consumables for Minimising Sample Cross-Contamination

IP.com Disclosure Number: IPCOM000241499D
Publication Date: 2015-May-07

Publishing Venue

The IP.com Prior Art Database

Abstract

[1] A manual punching device that uses disposable punch heads - The design for the proposed device incorporates a single body with interchangeable punch dies which can be discarded after a single use in an analogous way to the disposal of pipette tips after use. The punches would come in standard diameter sizes ranging from 1.2 - 6 mm. The punch device could be provided singularly for each punch diameter size or have a common interface design that corresponds and interfaces with all the punch dies provided.

[2] Consumable for an automated punching device using disposable punch heads – An additional embodiment is based upon a standard SBS-foot print plate that contains individual disposable punching dyes arranged into traditional 96- or 384 formats. This format and arrangement of disposable dyes is compatible to the majority of commercially-available automated liquid handling/paper punching platforms. The platform head is designed and engineered so that it is capable of picking up individual dyes, punching the solid support and subsequently placing the used dye into a corresponding 96/384 collection plate for subsequent disposable or cleaning i.e. this collection plates should have the additional advantage of facilitating dye de-contamination e.g. with either a disinfectant, suitable cleaning reagent or autoclave facilitating the subsequent re-use of the dye.

This invention may be applied to clinical diagnostic applications (pathological [viral, HIV, STD] screening, genotyping, neonatal & carrier screening, pre-implantation genetic diagnosis, personalised medicine etc), but also in systems that incorporates a punching step in the workflow e.g. forensics/STR analysis, genetic genealogy testing and human identification processes. Indeed, coupled with a chemically impregnated or non-treated solid supports, the device & method described here could be readily utilised with direct PCR processes in which the actual punch containing the biological material is added directly to the downstream reaction increasing the attractiveness of the device and workflow to users. Clearly, in a multi-well format the punch and method could be applied to multi-analyte testing.

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Punch Device & Consumables for Minimising Sample Cross-Contamination

Introduction

Biological sample collection on dry solid supports is a convenient and cost-effective method for the storage and transportation of biological materials, obviating the need for either specialised and expensive storage facilities or transportation procedures. Biological samples e.g. blood, urine, tissue, plants etc is applied to the solid support and allowed to dry before the solid support is stored at ambient temperature in the presence of a desiccant for prolonged periods of time. Under these conditions, analytes such as DNA, RNA and protein demonstrate minimal degradation. For example DNA stored on the chemically impregnated Whatman/GE Healthcare FTA cards has been shown to be stable for up to 23 years.

Solid support sample collection devices are traditionally composed of cellulose-based papers impregnated with chemicals that confer; antimicrobial, protein denaturing and pro-longed storage properties. They are also available non-chemically treated e.g. Whatman/GE Healthcare 903 blood collection devices are used for screening neonates for metabolic and genetic diseases.

In instances when a non-coloured sample e.g. saliva, cervical vaginal cells, cerebral spinal fluid is stored the solid support material is often coated with a coloured indicating chemical or dye to indicate successful sample collection Dye discolouration also indicates  sample location which facilitates analyte extraction for downstream processing. Recently non-cellulose based solid supports such as alginates etc have been shown to exhibit comparable sample collection, storage and transportation properties.

A typical workflow using any of the commercially-available solid support sample collection products involves, i) the application of the biological sample of interest ii) sample drying, iii) storage or transportation iv) a representative sample of the biological material (commonly referred to as a punch) is excised using a punch device and v) the biological moiety of interest is either extracted from the paper punch for testing or the punch and biological material are used in a direct workflow in which the actual punch is added directly to the downstream analytical reaction mixture.

To prevent cross-contamination or sample carry-over between samples, the device used to generate the punch is typically either discarded and a fresh device used for the next sample or cleaned by punching a blank card (known as a cleaning punch). Both methods are time consuming e.g. opening of multiple packages and costly e.g. disposable of a multiple devices. Incorporating cleaning punches into the punching workflow also adds time and may not always be 100% successful, and a degree of a sample carry-over may occur in which material from one punch contaminates a second punch.

When following the above workflows especially for certain applications such as viral diagnostics (e.g. HIV testing) there is a much greater em...