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Patent Searching and Data


Title:
SAMPLE HOLDER
Document Type and Number:
WIPO Patent Application WO/2000/076664
Kind Code:
A1
Abstract:
The sample holder consists of an elongate strip (2) that can be folded into three. The central section (7) has one or more patches (3) of absorbent material on which biological samples may be stored. About the peripheral edges of the elongate strip adhesive (10) is provided so that once the sample is in place on the patch (3), the elongate strip may be folded up and the sample sealed inside away from any contaminants.

Inventors:
LORENTE-ACOSTA JOSE ANTONIO (ES)
LORENTE ACOSTA MIGUEL (ES)
Application Number:
PCT/GB2000/002366
Publication Date:
December 21, 2000
Filing Date:
June 15, 2000
Export Citation:
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Assignee:
UNIV GRANADA (ES)
WHATMAN INTERNAT LTD (GB)
LORENTE ACOSTA JOSE ANTONIO (ES)
LORENTE ACOSTA MIGUEL (ES)
International Classes:
B01L3/00; A61B10/00; G01N1/00; (IPC1-7): B01L3/00; G01N33/52
Domestic Patent References:
WO1997019754A11997-06-05
Foreign References:
US5783759A1998-07-21
US4420353A1983-12-13
US5273888A1993-12-28
GB1585127A1981-02-25
US4925029A1990-05-15
Attorney, Agent or Firm:
Perkins, Sarah (Stevens Hewlett & Perkins Halton House 20/23 Holborn London Greater London EC1N 2JD, GB)
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Claims:
CLAIMS
1. A sample holder suitable for use in the storage of biological or mineral samples, the sample holder comprising a main body having a sample receiving section with one or more patches of absorbent material disposed thereon; a first cover section foldable about a first fold line over the sample receiving section; and sealing means disposed so as to form a sealed enclosure between the sample receiving section and the cover section about the one or more patches of absorbent material.
2. A sample holder as claimed in claim 1, wherein the sealing means comprises adhesive.
3. A sample holder as claimed in claim 2, wherein the adhesive is disposed as a pair of opposed lines of adhesive extending away from the first fold line so as to form a pair of continuous seals either side of the patches of absorbent material.
4. A sample holder as claimed in any one of the preceding claims, wherein the adhesive is disposed as a continuous line of adhesive extending substantially parallel to the free edges of the first cover sheet.
5. A sample holder as claimed in any one of the preceding claims, wherein a second cover section is provided foldable about a second fold line to at least partly cover the first cover section.
6. A sample holder as claimed in claim 5, wherein the first and second cover sections lie on opposing sides of the sample receiving section.
7. A sample holder as claimed in 6, wherein further sealing means are provided to secure the second cover section to the first cover section.
8. A sample holder as claimed in any one of the preceding claims, wherein the sample receiving section includes a plurality of patches of absorbent material and the first cover section is divided into a plurality of individual flaps whereby the sealing means is disposed so as to form separate sealed enclosures between the sample receiving section and each of the flaps of the cover section about one or more patches of absorbent material.
9. A sample holder as claimed in any one of the preceding claims, wherein each of the one or more patches of absorbent material is attached to the sample receiving section along an edge.
10. A sample holder as claimed in any one of the preceding claims, wherein the one or more patches of absorbent material are filter paper.
11. A sample holder as claimed in claim 10, wherein the filter paper is treated to preserve one or more components of the sample.
12. A sample holder as claimed in either of claims 10 or 11, wherein the filter paper is coloured so as to indicate when a sample has been applied.
13. A sample holder as claimed in any one of the preceding claims, wherein the main body has an outer waterresistant surface.
14. A sample holder suitable for use in the storage of biological or mineral samples, the sample holder comprising a main body having a sample receiving section; a first cover section foldable about a first fold line over the sample receiving section; and sealing means disposed so as to form a sealed enclosure between the sample receiving section and the cover section within which a biological or mineral sample may be contained.
15. A sample holder as claimed in claim 14, wherein sample holding means are disposed on the sample receiving section to substantially immobilise a sample located in the sample receiving section.
16. A sample holder as claimed in claim 15, wherein the sample holding means comprises an adhesive layer.
17. A sample holder as claimed in any one of claims 14 to 16, wherein the sealing means comprises an adhesive.
Description:
SAMPLE HOLDER The present invention relates to a sample holder and in particular to a sample holder suitable for use in the storage of small volumes of biological specimens such a blood.

Particularly in a hospital environment, biological samples such as blood are collected and stored in vials or test tubes. Similarly, test tubes and swabs are often used by forensic scientists when collecting biological samples from a crime scene. In US4777964 a sample holder is described specifically intended for home use with blood samples that are to be sent for HIV testing. The sample holder consists of a carton with a pocket in which an elongate glass tube is located. In use, a person pricks their finger and introduces blood into the glass tube which is then sealed at each end using a clay-like substance which is provided. The sealed glass tube is then placed in the pocket in the carton and covered with a flap which is secured to the body of the carton using adhesive tape. The closed carton is placed within a plastic bag and separately labelle and then the carton and the plastic bag are placed within an envelope so that the carton, with the sample inside, can be mailed to a testing laboratory. Other examples of sample holders can be found in EP0473190, EP0734684 and US4925029 all of which involve the use of a separate vial or tube in which the sample is collected.

More recently, filter paper has been used in the collection and storage of small quantities of biological samples. The filter paper is usually attached to an elongate strip of paper that can be folded about the filter paper and on which details such as the name of the person from which the sample was taken can be printed. As the filter paper absorbs the fluid sample, the filter paper renders the sample immobile thereby avoiding the need for costly and bulky glass vials or test tubes. Similarly, samples of hair and nails may be immobilised in a similar sample holder by providing an adhesive surface on the strip of paper, instead of a filer paper, to which the hair sample is adhered. Where it is intended to store the biological

samples, filter paper may be used, such as that described in US5976572, which is treated with a preservative. Usually, where a biological sample is to be stored or is to be sent to a laboratory, the sample holder is placed within a separate envelope which also bears details of the sample and/or an addressee.

Although sample holders employing filter papers avoid the disadvantages of bulky and costly glass vials or test tubes which can be prone to breakage, such sample holders present their own problems. Most importantly, sample holders that employ filter paper are prone to contamination which is of particular importance if the sample holders are to be used by forensics at the crime scenes. Also, as the sample holder is stored in a separate envelope there is the risk that, in error, the labelling on the envelope may not match the details of the sample inside.

The present invention provides an improved sample holder that seeks to overcome the problems identified above with existing sample holders and in particular prevents contamination of samples and the reduces the risks of mislabelling of samples.

The present invention provides a sample holder suitable for use in the storage of biological or mineral samples, the sample holder comprising a main body having a sample receiving section with one or more patches of absorbent material disposed thereon; a first cover section foldable about a first fold line over the sample receiving section; and sealing means disposed so as to form a sealed enclosure between the sample receiving section and the cover section about the one or more patches of absorbent material.

Thus, with the present invention a sample holder is provided that as a single entity is able to receive a biological or mineral sample and contain the sample in a sealed enclosure which is suitable for use in the mail or for long term storage of samples. Moreover, the sample holder may include regions for private and public data to be displayed. Such data may be in the form of sample identification, barcodes, custody chain, sample source data such as patient identification or identification of the location of the

sample source as well as postal information such as sender and addressee.

Preferably, the sealing means is an adhesive which may be disposed as a pair of opposed lines of adhesive extending away from the first fold line so as to form a pair of continuous seals either side of the patches of absorbent material. Or the adhesive may be disposed in a continuous line of adhesive extending substantially parallel to the free edges of the first cover sheet.

Also a second cover section may be provided which is foldable about a second fold line to at least partly cover the first cover section.

Preferably, the first and second cover sections will lie on opposing sides of the sample receiving section and further sealing means may be provided to secure the second cover section to the first cover section.

In a preferred embodiment the sample receiving section includes a plurality of patches of absorbent material and the first cover section is divided into a plurality of individual flaps whereby the sealing means is disposed so as to form separate sealed enclosures between the sample receiving section and each of the flaps of the cover section about one or more patches of absorbent material.

Ideally, the one or more patches of absorbent material are filter paper which may or may not be treated with a preservative.

In a separate aspect the present invention provides a sample holder suitable for use in the storage of biological or mineral samples, the sample holder comprising a main body having a sample receiving section; a first cover section foldable about a first fold line over the sample receiving section; and sealing means disposed so as to form a sealed enclosure between the sample receiving section and the cover section within which a biological or mineral sample may be contained.

The sample holder may include sample holding means in the form, for example, of an adhesive strip for immobilising the sample in the sample holder.

Embodiments of the present invention will now be described by way

of example with reference to the accompanying drawings, in which: Figure 1 is a plan view of a first embodiment of a sample holder in accordance with the present invention; Figure 2 is a perspective view of the sample holder of Figure 1 in a partially foldedstate; Figure 3 is plan view of the sample holder of Figure 1 from the other side; Figure 4 is a plan view of a second embodiment of a sample holder in accordance with the present invention; Figure 5 is a perspective view of the sample holder of Figure 4 in a partially folded state; Figure 6 is a perspective view of a third embodiment of a sample holder in accordance with the present invention; Figure 7 illustrates a fourth embodiment of a sample holder in accordance with the present invention; and Figure 8 illustrates a fifth embodiment of a sample holder is accordance with the present invention.

The sample holder shown in Figure 1 generally comprises a main body in the form of an elongate supporting strip 2 to which is attached one or more sample absorbent patches 3. The elongate strip 2 is preferably made of paper, card or a plastics material onto which sample data may be printed, stamped, written or adhered using adhesive labels. The elongate strip 2 has two approximately equidistant fold lines 4 so that the elongate strip 2 is divided into three sections and can be folded with the outer edge sections 5,6 folding over the central or sample receiving section 7.

The absorbent patches 3 are preferably made from a filter paper such as BFC180,3MM or 31 ET (Whatman International Ltd. graded filter paper) or FTA (Whatman International Ltd) which is an example of a filter paper specifically treated to lyse cells and preserve the released nucleic acids. The patches are suited to the deposit of samples either by means of instruments such as syringes and pipettes or by direct contact for example with a finger or a plant stem, for example. Also, the patches 3 may be

coloured so that once a sample has been applied to a patch it is clearly visible as a result in a change in the colour of the patch. The patches 3 are attached to the central section 7 of the elongate strip 2 and are positioned so as to be separate from one another. Although two patches 3 are shown in Figure 1 it will be immediately apparent that different numbers of patches and different arrangements of patches may be employed, as necessary.

Each of the patches 3 is attached to the elongate strip 2 along one edge 8 by means of adhesive, for example, or alternatively through mechanical securement using staples, for example. Each patch 3 is attached to the elongate strip 2 in such a way that the main body 9 of the patch is free of the elongate strip and is able to absorb a fluid biological sample applied to it, such as blood. In an alternative arrangement the elongate strip may comprise filter paper and the patches are an extension to the elongate strip which is folded in on itself in a concertina or spiral arrangement.

Self-adhesive tape 10 is arranged along the peripheral edges of the outer sections 5,6 of the elongate strip. Thus, the self-adhesive tape 10 extends along the opposing free ends of the elongate strip and at least partly along each side edge of the elongate strip 2 up to the fold lines 4.

The self-adhesive tape 10 adheres to the elongate strip and has a removable protective covering of a release material over its upper adhesive surface. Instead of the self-adhesive tape 10 alternative adhesives such as a pressure sensitive adhesive or a heat activated adhesive may be deployed about the edges of the elongate strip. However, the adhesive 10 provided along the edges of the elongate strip 2 is preferably continuous about the peripheral edges of the outer sections 5,6. The adhesive 10 may additionally extend along the edges of the central section 7 of the elongate strip and either side of the fold lines 4. The adhesive may be omitted from the free transverse edge of the first edge section and instead two opposing substantially parallel lines of adhesive tape may be provided which follow the longitudinal edges of the first edge section. It will, of course, be apparent that the adhesive tape need not follow the edges of the outer edge section. The adhesive tape is required only to provide a

sealed enclosure between the central section and the first edge section.

The sealing to the enclosure may be direct between the central section and the first edge section or indirect as a result of adhesion between the first and second edge sections. Of course, sealing means other than adhesive may be used to generate the sealed enclosure for the sample such as a mechanical securement mechanism such as edge grippers or clips.

In use, a biological specimen such as blood or animal or plant tissue such as tree sap is applied to an absorbent patch 3 and allowed to dry. At the same time or after the sample has dried, data on the sample is added to the second edge section 6 of the elongate strip. The edge section 6 may be pre-printed to identify the data required such as name, date of sample collection etc. Additionally, or in the alternative, the edge section 6 may include a space 11 where a label bearing an identification barcode may be adhered. Once, the biological sample has dried and the sample data added to the second section 6 of the strip, the release material is removed from the adhesive strip 10. Firstly, the first edge section 5 of the elongate strip is folded over the central section 7 to cover the absorbent patches 3.

The adhesive strip 10 on the edges of the first edge section thus adheres to the periphery of the central section 7 surrounding the absorbent patches.

In this way the absorbent patches with the biological samples are wholly enclosed by the folded line of the first edge section 5 with the central section 7 and by the continuous adhesion of the adhesive strip 10 to the edges of both the edge section and the central section. Next the second edge section 6 is folded about its fold line so as to cover the back of the first edge section 5 and the self-adhesive strip 10 about the peripheral edges of the second edge section 6 adheres to the exposed back of the first edge section. In this way the sample data applied to the second edge section 6 is protected from the sample applied to the patch 3 but is also hidden and so personal information such a patient details can be kept private. The order of the folding of the sections of the sample holder is more clearly illustrated in Figure 2.

In this way the sample holder, once folded, is a third of its original

size. Moreover, the samples on the absorbent patches are wholly contained and protected against external contamination within a space enclose along all sides either by means of the fold line between different sections of the strip or by means of the adhesion of the self-adhesive strip to the edges of the three sections of the strip. Also, where a permanent adhesive is used as the self-adhesive strip 10, the sample holder will be able to provide evidence of any tampering as any attempt to open the sample holder should tear or damage the elongate strip 2. Alternatively, a permanent adhesive may be used in combination with a resealable adhesive so that the sample holder is capable of providing evidence of tampering but also permits the sample holder to be re-sealed after opening, where necessary. Suitable adhesives include a water-based adhesive such as a pva adhesive or an acrylic copolymer pressure sensitive adhesive.

As illustrated in Figure 3, the back of the sample holder may be used to print information such as a custody chain for the sample so that the provenance of the sample can be traced. Also, the same identification code label may be adhered to the back of the sample holder so that the contents of the sample holder can be identified without the need to open the sample holder. Furthermore, the sample holder acts as its own, integral envelope and so postal details can be added to the back of the sample holder when it is intended that the sample be mailed to a laboratory or clinic.

Although not shown n the figures, the elongate strip 2 may be provided with a water protective cover on its back surface so that when the sample holder is folded, the holder is protected from the ingress or seepage of water or other fluid contaminants.

In Figure 4 an alternative sample holder is illustrated. The sample holders of Figures 1 and 4 are similar and so like elements have been identified using the same reference numerals. The sample holder of Figure 4 is particularly suited for clinical use and is intended for use where a plurality of different tests are to be performed on a plurality of samples

taken from the same patient.

The sample holder comprises an elongate strip of card 2 that is divided by fold lines 4 into three sections 5,6,7. The second edge section 6 is identical to that shown in Figure 1 and provides space for information to be printed or attached regarding the patient. The central section 7 has a series of four absorbent patches 3 arranged in a line transversely across the central section. Each patch 3 has deliminated on it two separate regions so that each patch defines a row 12 of two separate samples.

Adjacent each row 12 is printed identification of a clinical department for which the samples are intended or the type of test to be performed on the samples provided on the patch in that row.

The first edge section 5 has three cuts 13 extending substantially parallel to one another and to the longitudinal edges of the strip 2. The cuts 13 extend the entire length of the first edge section 5 and are aligned with the edges of the rows 12 of the central section 7. The cuts 13 divide the first edge section into four independently foldable flaps 14. Lines of pressure-sensitive adhesive 15 are provided along the edges of each flap 14 and along the peripheral edges of the second edge section 6.

In use, repeat samples, for example of blood, are provided in each area deliminated on each of the patches so that there are two separate samples in each row. The same test may then be performed on each pair of samples with different tests being performed on samples in different rows. After each test is completed the flap 14, corresponding to the row where a test has been carried out, can be folded over the patch 3, independently of the other flaps, and sealed by means of the pressure sensitive adhesive about the patch 3. Thus, where the sample holder is being transferred between clinical departments for the performance of different tests on the samples, each of the patches having samples on which tests have been completed can be isolated from the remaining samples by folding and sealing the corresponding flap around the patch.

Once all of the tests have been completed, four separate sealed spaces remain with a single patch within each space. Then the second edge

section may be folded over each of the folded flaps to seal around the outermost edges of the flaps to provide a double seal to each of the samples. As before identification data may be provided on the back of the sample holder along with any mailing information, if relevant.

It will be appreciated that individual patches may be pre-treated with different preparatory substances in dependence on the tests to be carried out on the samples on each patch. Alternatively, individual patches may be of different material depending upon the test to be performed. Moreover, although in Figure 4 four rows of patches are shown with two sample regions on each patch, the number of sample regions and the number of rows can vary as desired. In one embodiment of a sample holder, similar to that of Figure 1, a single absorbent patch of material is provided in the central section having an array of 8 x 12 sample regions deliminated on the patch. This arrangement is particularly suited to use with automated test apparatus.

With reference to Figure 6 a third embodiment of a sample holder is illustrated. The sample holder in Figure 6 is similar to those of figures 1 and 4 except that the central section 7 does not have any absorbent patches. The central section may be bare or may include a strip of pressure-sensitive adhesive. The edge sections 5,6 of the elongate strip 2 are the same as for the sample holder shown in Figure 1. With the sample holder of Figure 6, non-fluid samples such as hair and nail samples may be collected and stored. The hair samples may be placed loose on the central section 7 before being encased by the first edge section folding over the hair and sealing along the edges of the section or the hair samples may be adhered to the pressure sensitive adhesive provided in the central section before the first edge section 5 is folded over to seal around the edges of the central section 7. This sample holder is suitable for use both in forensic sciences and in dermatology and tricology.

In Figures 7 and 8 further alternative versions of the sample holder are illustrated. In Figure 7 the main body of the sample holder consists of only a sample receiving section 7 and a cover section 5 which are joined

along a foldline 4. In Figure 8 a more complex arrangement is illustrated in which the main body has a central section 7, first and second opposing cover sections and a further side cover section 17 which folds over the first cover section 5 to seal one of the longitudinal edges of the central section and is sandwiched between the first and second cover sections.

The sample holders described above are robust and provide reliable protection from contamination and a tamper-evident construction. It will, of course, be apparent that the size and shape of the sample holders is in no way restricted to the particular sizes and shapes illustrated in the accompanying figures. The sample holders are suitable for use in forensic sciences such as in the compilation of DNA databases including human identification trials and population studies, in paternity testing, DNA identification of babies and particularly in sample collection at crime scenes where the avoidance of cross-contamination is essential. The sample holders are also suitable for use in clinical medicine such as genetics diagnosis and epidemiology as well as anthropology and animal genetics.

Although reference herein has focused on human biology it will be apparent that the sample holder is equally suited to use in animal and vegetable biological analysis and mineral analysis.