ZA201101080B - Kit and method for collecting fluid samples in order to perform dried fluid spot (dfs) tests thereon - Google Patents

Description

He : 17201170108

KIT AND METHOD FOR COLLECTING FLUID SAMPLES IN ORDER TO

PERFORM DRIED FLUID SPOT (DFS) TESTS THEREON

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to devices and methods for the collection of fluid samples in order to perform dried fluid spot (DES) tests thereon. More particularly, the invention relates to a kit useful for facilitating the performance of such DFS tests in a manner which is efficient, convenient and of low cost, and which enables more reliable results to be obtained, and reduces the possibility of false positive results.

The invention is intended to be used for testing all biological fluids, particularly body fluids, such as dried blood spots (DBS), dried plasma spots (DPS), dried semen spots (DSS), dried urine spots (DUS), etc. Since the invention is especially useful for dried blood spots, for the convenience it will be described below for DBS

Dried fluid spot (DFS) testing is now widely used for detecting HIV infections and other conditions, examples of which are listed below. -Infectious Diseases 'HIV-1/2 Qualitative NAT Testing

HIV-1/2 Quantitative Viral Load

HIV-1/2 Antibody/Antigen Serological Testing HIV-1/2 Confirmation Testing

Malaria NAT Testing . Hepatitis A/B/C NAT Testing :

HIV-1/2 Resistance Testing Mycobacterium NAT Testing

Epstein Barr Virus Qualitative NAT Testing

TORCH Panel Screen

Varicella Zoster Testing

Genetic Testing

Parentage Determination )

Cystic Fibrosis

Fragile X-Syndrome

Sickle Cell Anemia

Duchene muscular dystrophy

S Down Syndrome Screening

Newborn Screening for Inherited Genetic Disorders

Cytochrome P450 Screening

Factor V Leiden Mutation

Neonatal Metabollite Screening >

Chemistry and Endocrinology Testing

HbA1C Levels

HIV Antiretroviral Drug Levels

For purposes of performing this type of test, dried fluid spot specimens are collected by applying a few drops of blood, drawn by a lancet, from the finger, heel, toe, etc. of the subject onto specially manufactured absorbent filter paper. The blood is allowed to thoroughly saturate the paper and is air dried for several hours. Specimens are stored in low gas—permeability plastic bags, with desiccants added to enhance the drying of the fluid sample. The absorbent filter paper saturated with the dried fluid spot is then forwarded to a laboratory for examination, wherein a small disc of the blood-saturated paper is separated, e.g. using a hole punch. The disc is then immersed in a buffered saline solution on a flat bottomed microtitre plate, and forms the “master” from which various tests may be performed according to the infection or condition desired to be detected.

This sampling technique has many advantages and these include a reduced need for refrigeration,simpler transporting, no specialized storage facilities required, samples can be stored for longer time periods, small amounts of fluid is needed and in most cases the DFS is easier to take from the patient . However, they are generally characterized by a larger percentage of “false positives” compared to conventional techniques for testing liquid blood specimens.

OBJECTS AND BRIEF SUMMARY OF THE INVENTION

An object of the present invention is to provide a kit facilitating the collection of a fluid sample, particularly a blood sample, from a subject in a manner having advantages in the above respects. Another object of the invention is to provide a method for collecting a fluid sample from a subject having advantages in the above respects.

According to a broad aspect of the present invention, there is provided a kit for use in the collection of a fluid sample from a subject in order to perform a dried fluid spot (DFS) test thereon, comprising: an outer housing including an article holder within the outer housing; and a DFS collection card to be removably held on the article holder within the outer housing; the DFS collection card having an absorbent region for receiving the fluid sample to be tested; the outer housing being openable and closeable and constructed such that, with the article holder received therein, it can be used as a container for forwarding the DFS collection card to a testing facility for testing the fluid sample. i5 In one described preferred embodiment, the article holder is a separate unit from ! | the outer housing and is removably received therein when the outer housing is closed.

More particularly, the outer housing is constructed to have its opposite ends open for slidably receiving the article holder; and the article holder is constructed with end walls ‘closing the open ends of the housing, when the article holder is received therein, to thereby enable the housing with the article holder therein, to serve as the container for forwarding the DFS collection card to a testing facility for testing the fluid sample.

In a second described preferred embodiment, the article holder is integrally formed as part of the outer housing. More particularly, the outer housing includes a flat sheet formed with a plurality of fold lines defining sections which are foldable with respect to each other into a box configuration, one of said sections being constructed to serve as said article holder for removably holding the article within the outer housing.

According to another feature in the described preferred embodiment the article holder further includes a desiccant for dehumidifying the container and the DFS + collection card therein forwarding the container to the testing facility.

The article holder may include bar code labels for application to the DFS collection card, the article holder, the container for forwarding the fluid samples to the

1:2011/010g¢ laboratory, and/or a test tube within the article holder and having a closure cap for receiving the DFS collection card for storage purposes.

According to further features in the preferred embodiment of the invention described below, the absorbent region in the DFS collection card includes a first area for 5 receiving a quantity of the fluid sample (e.g., blood sample), which first area is defined by weakened lines to facilitate removal of the first area and testing the fluid sample thereon. It may also include a second area for receiving another quantity of the fluid sample, and defined by similar weakened lines to facilitate removal of the second area and testing the fluid sample thereon. The weakened lines defining the first area and the second area are of the same weakness . A third area is also preferably included for receiving a further quantity of the fluid sample, e.g., for storage purposes.

According to a still further aspect of the invention, there is provided a method of collecting a fluid sample from a subject in order to perform a dried fluid spot (DFS) test thereon, by using a kit as described above.

As will be described more particularly below, providing such a test kit for use in

DFS testing, particularly in dried blood spot (DBS) testing, enables such testing to be performed more efficiently, much simpler, less costly, less likely to produce false positive ~results, easier to transport or store, and/or less likely to subject the handlers to bioharzard risks, as compared to the conventional method of collecting and performing liquid blood tests.

Further features and advantages of the invention will be apparent from the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to two : kit constructions illustrated in the accompanying drawings, wherein Figs. 1-6 illustrate one kit construction wherein the article holder, for holding the DFS (more particularly the

DBS) collection card, is a separate unit from the outer housing and is removably received therein when the outer housing is closed; whereas Figs. 8-11 illustrate another construction wherein the article holder is integrally formed as a section of the outer housing. More particularly:

Fig. 1 illustrates one form of kit constructed in accordance with the present invention with the outer housing removed;

Fig. 2 illustrates the article holder in the kit of Fig. 1, the article holder being shown in its flat, unfolded form;

Fig. 3 illustrates the front face of the DFS collection card carried by the article : holder of Fig. 1;

Fig. 4 illustrates the rear face of the DFS collection card;

Fig. 5 illustrates the outer housing, in its flat unfolded form, for slidably receiving the article holder, and the DFS collection carried thereby, in a manner to permit the article holder to be conveniently slid outwardly to expose the DFS collection card for : receiving the fluid sample, and then inwardly for enabling the outer housing, with the article holder and DFS collection card to be used as a container for forwarding the collection card to a remote testing facility for testing the fluid sample on the collection card;

A 15 Fig. 6 is a front view of the outer housing of Fig. 5, showing the information to be carried thereon; : Fig. 7 is a rear view of the outer housing, showing the information to be carried thereon; . Fig. 8 illustrates another form of kit constructed in accordance with the present invention with the article holder, for holding the DFS collection card being integrally formed as a section of the outer housing, the outer housing being shown in Fig. 8 in its flat, unfolded condition, with the outer surface viewable;

Fig. 9 illustrates the flat condition of the outer housing of Fig. 8, but with the inner surface being shown;

Fig. 10 illustrates the outer housing of Figs. 8 and 9 in an intermediate folded condition;

Fig. 11 illustrates only the section of the outer housing of Figs. 8 and 9 serving as the article holder each pivotally mounted with the DES collection card held thereon; and

Figs. 12a and 12b illustrating the two sides of the card.

It is to be understood that the foregoing drawings, and the description below, are provided primarily for purposes of facilitating understanding the conceptual aspects of the invention and possible embodiments thereof, including what is presently considered to be a preferred embodiment. In the interest of clarity and brevity, no attempt is made to provide more details than necessary to enable one skilled in the art, using routine skill and design, to understand and practice the described invention. It is to be further understood that the embodiments described are for purposes of example only, and that the invention is capable of being embodied in other forms and applications than described herein.

DESCRIPTION OF A PREFERRED EMBODIMENT

As indicated earlier, the illustrated kits constructed in accordance with the present invention are for use in the collection of a blood sample from a subject in order to perform a dried fluid spot (DES) test thereon in order to determine the presence or absence of any one of a number of conditions, such as listed earlier above. Two construction kits are described for purpose of example. In one (Figs. 1-7), the article holder for carrying the DFS collection card, is a separate unit from the outer housing and is removably received therein when the outer housing is closed. In the second construction (illustrated in Figs. 8-11), the article holder is integrally formed as a section .of the outer housing.

The Kit of Figs. 1-6

Briefly, the kit illustrated in Figs. 1-6 includes an outer housing, shown in flat form in Fig. 5 and generally designated 10; an article holder within the outer housing, the article holder being shown at 20 in Fig. 1 and in flat, unfolded form in Fig. 2; a DFS collection card, generally designated 30 in Figs. 1, 3 and 4; a test tube, generally designated 40, illustrated in Fig. 1; a plurality of bar—code labels, generally designated 50 in Fig. 1; a plurality of other articles, schematically indicated at 60 in Fig. 1; a tweezers 70 illustrated in Fig. 1; and a disposable spring-loaded lancet, schematically illustrated at 80 in Fig. 1. Each of the foregoing elements may be releasably retained on the article holder 20 in any suitable manner, such as by forming suitable recesses in the article carrier for locating and receiving the respective articles, by applying pressure-sensitive tape or cords for removably receiving the respective articles, etc. :

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Fig. 1 shows the article holder 20 in its folded condition for being slidably received within the outer housing 10, which is shown in its flat, unfolded condition in

Fig. 5. Fig. 2 illustrates the article holder also in its flat, unfolded condition.

Thus, as shown particularly in Fig. 5, the outer housing 10, when in its flat unfolded condition, includes a stiff sheet, of cardboard or plastic, of rectangular : configuration formed with the following fold lines: fold line 11 at one end defining a side wall 12 or part thereof; fold line 13 at the opposite end, defining a side wall 14 cooperable with side wall 12 to define the respective side of the outer housing; and two parallel, spaced fold lines 15, 16 in the inner region of the sheet defining the opposite side wall 17 of the outer housing. It will be appreciated that when the sheet 10 is folded along the respective fold lines illustrated in Fig. 5, it forms an outer housing open at its opposite ends, much like a matchbox for receiving a plurality of matches carried by a match holder receptacle slidably received within the outer housing.

The article holder 20 received within the outer housing 10 is illustrated in its folded condition in Fig. 1, and in its flat, unfolded condition in Fig. 2. Thus, as shown in

Fig. 2, the article holder 20 includes a central main panel 21 of rectangular configuration, and a side panel 22, 23, 24 and 25 on each of the four sides of the main panel 21 and foldable perpendicularly thereto along fold lines 22a-25a, respectively. A central section of the lower side panel 25 is marked with a box 26 for receiving the identification of the blood sample to be carried thereby; and the central region of the lower part of the main panel 21 may also be marked with a similar box 27 for the same reasons, or for other identification purposes.

It will be appreciated that when the article carrier panel 21 is folded along the fold lines 22a—25a, and is slidably received within the outer housing 10, the outer side panels 22-25 will engage, and be slidable along, the inner surface of the outer housing 21 for enabling the article carrier to be slid to open and closed positions through the opposed end openings of the outer housing, in order to expose the various articles carried by the : inner central panel 21 of the article carrier 20.

Fig. 1 illustrates the various articles carried by the article carrier 20. The most important article carried by the article holder 20 is the DFS collection card 30 having an absorbent region 31 (e.g. filter paper) for receiving the blood sample or samples to be tested. As further shown in Fig. 1, also carried by article holder 20 are a plurality of bar code labels 40 for attachment to the various articles within the kit in order to identify the user of the kit, and particularly the donor of the blood sample to be tested.

Figs. 3 and 4 illustrate the front face and back face, respectively, of the DFS collection card 30. Thus, the absorbent region 31 includes three circular areas 31a, 31b, 31c, for receiving a quantity, e.g. a drop, of blood to be used for testing. Circular area 31a is defined by weakened lines 32a to permit pushing-out or punching-out the circular area, with the dried fluid spot thereon to be used for testing; circular area 31b is preferably also defined by weakened lines 32b, but less weak than weakened lines 32a of circular area 31a, to permit testing of the blood spot thereon if desired; and circular area 31c defined by circular line 32c, but not weakened, or weakened to a lesser extent, than the other two circular areas, to permit this circular area also to be used for storage or further testing purposes. , The DFS collection card 30 further includes a rectangular region 33, e.g. at its top, i . ~ 45 for receiving one of the bar code labels 40 in order to identify the user of the respective collection card. 5 The rear side of the DFS collection card 30, shown in Fig. 4, is similarly . constructed as described above, but preferably also includes an area 34 for identifying the user of the collection card by name, date, etc.

Fig. 6 illustrates the front panel 10a of the outer housing 10 in the folded condition of the housing. Thus, as shown in Fig. 6, the front panel 10a of the outer housing 10 includes a region 18a identifying the kit as being a “Dried fluid spot

Collection Kit”; a region 18b for receiving one of the bar code labels 40 for identifying the user of the kit; and a further region 18c for the laboratory address to which the collected blood sample is to be sent for testing.

Preferably, the outer surface of the rear panel 10b, shown in Fig. 7, includes a list of the contents 19a of the kit, and also brief instructions 19b in the use of the kit.

As further seen in Fig. 1, the article holder 20 in the kit further includes several other articles, such as an alcohol pad, a gauze pad, and a desiccant, all schematically indicated by reference numeral 50 in Fig. 1, and all located under the collection card 30.

The kit illustrated in Fig. I further includes a test tube bottle 60 closed by closure cap 61 for handling or storing the tested blood spot. As shown in Fig. 1, a bar code label 41 is applied to the test tube in order to identify the sample within the tube. Further included are a pair of tweezers 70, and a disposable spring-loaded lancet, in sterile condition, as schematically shown at §0.

The Manner of Using the Kit of Figs. 1-6

Following is an example of one manner of using the illustrated kit.

As indicated above, the kit, when supplied to the user, includes the outer housing folded along the illustrated fold lines to form a four-sided housing open at its opposite 10 ends. In addition, the article carrier 20 illustrated in Fig. 2 is also folded along its fold lines to define a bottom panel 21 slidable along the inner surface of the bottom panel of the outer housing, and four perpendicularly-extending side panels 22-25 engagable with ~ the inner surfaces of the side panels of the outer housing 10. The article carrier 20 is thus slidably received within the outer housing 10 and is movable with respect to its opposite open ends to an open position or to a closed position, much like in a match-box containing a plurality of matches.

In addition, the kit as supplied to the user includes all the articles illustrated in : “Fig. 1, namely the DFS collection card 30, a plurality of bar code labels 40, the alcohol pad, gauze pad and desiccant schematically designated at 50; the test tube 60; the pair of tweezers 70, and the disposable spring-loaded lancet as schematically illustrated at 80.

All such articles may be releasably held in any suitable manner, such as described above.

When the kit is to be used for collecting a blood sample, the article carrier 20 is slid to its open condition, thereby exposing the contents of the kit. The area of the skin to be punctured is cleaned with the alcohol swab, oriented downwardly, punctured by the lancing device, and pressed against the respective area of the absorbent region 31 of the

DFS collection card 30. The gauze is then applied to the punctured site, and the lancet is + disposed into a sharps container. A bar code label 40 is then applied to region 33 on the front of the collection card 30, to the test tube 60, and to region 18b on the outer face of the rear panel of the outer housing 10.

ES 11.

The kit is then suitably closed to serve as a shipping container and mailed to the laboratory address appearing in region 18c of the rear panel 10b of the outer housing, as shown in Fig. 6.

The laboratory removes a DFS spot (e.g. 31a) on the collection card 30 and manipulates it by the use of the tweezers 70 perform the appropriate pathology test thereon according to the type of test to be performed. The first spot area 31a, which is most easily removed by its weakened lines 32a will first be removed for testing, which can be done in any suitable manner. If desired, the second spot area 31b can be removed to perform further tests, or to corroborate the test of the first spot area. The third spot area 3lc is preferably retained on the card and stored, e.g. for future reference or testing purposes.

The Embodiment of Figs. 8-12

As indicated earlier, whereas in the embodiment of Figs. 1-7 the article holder is 3 ‘d separate unit from the outer housing and is received within the outer housing when § 15 closed, in the embodiment of Figs. 8-11 the article holder is integrally formed as a a section of the outer housing. Such an arrangement simplifies the construction and the manner of its handling. , » Thus, as shown in Figs. 8 and 9, the kit includes a flat sheet, generally designated

X 100, formed with a plurality of fold lines defining a plurality of sections which are folded with respect to each other into a box configuration. Fig. 10 illustrates the partially—open - folded condition of the outer housing.

As more particularly illustrated in Figs. 8 and 9, sheet 100 is formed with fold lines to define panel sections 101 and 102, serving as the upper and lower panels of the outer housing, and panel sections 103-106 serving as the four side walls of the housing.

In addition, sheet 100 is formed with an additional panel section 107 integrally formed with side wall 106 and defined by a fold line therebetween, serving as the article holder for holding the DFS card thereon. Fig. 11 illustrates the DFS card, therein designated 110, as carried on the inner surface of panel section 107. , Both the outer surface of sheet 100, as illustrated in Fig. 8, and the inner surface of the sheet as illustrated in Fig. 9, carry various indicia markings to enable its use in the : collection and performance of dried fluid spot tests on the collection card carried by panel section 107, the back side 110a of the card being shown in Fig. 12a, and the front side 110b of the card being shown in Fig. 12b.

Thus, as shown in Fig, 9, illustrating the inner surface of sheet 100, panel section 107 serving as the carrier for the collection card 110 is formed with indicia markings instructing the user to apply the collection card to that surface. This panel section is further formed with a pair of slits 107a, 107b, for receiving the collection card 110.

After the collection card has been inserted into the slits of panel section 107 (Fig. 9), the panel section is folded over panel section 101, serving as the bottom of the housing, and panel section 102 serving as the top cover of the housing. The inner surface of panel section 102 is provided with instructions, as shown by indicia markings thereon, which are exposed to the user to guide the user in using the illustrated device for collecting the test samples and for forwarding them for testing purposes.

As further shown particularly in Figs. 9 and 10, panel section 102 is integrally : formed with a tab 108, receivable within a slot 109 formed at the juncture of panel section 101 with end wall section 106 to close the box and to use it as a shipping : container for shipping the fluid sample to a remote location for testing purposes.

Fig. 8, illustrating the outer surface of the shipping container 100 in its flat condition, includes additional indicia helpful in using the illustrated device. Thus, the ; outer surface of panel section 101 includes a listing of the kit contents, the outer surface of panel section 102 includes a marked region for the bar code identifying the respective fluid sample, and also the laboratory address to which it is to be sent for testing purposes; and the outer surface of panel section 107 includes instructions directing the user to apply the fluid spot card to the inner surface of that panel section by inserting the corners of the card 110 into slots 107a and 107b.

It will be appreciated that when folding the flat sheet 100 into the box-like configuration, extension 103a of the end wall panel section 103 is folded against the main portion of the end wall panel section 103, and extension 103b is folded against the inner surface of the bottom wall panel section 101. The appropriate surfaces of these panel sections may be provided with an adhesive coating for this purpose. A similar construction and arrangement is used with respect to the opposite end wall panel section 105, and its extensions 105a, 105b.

The two ends of the bottom wall panel section 101 may be formed with semi- circular slits joined by fold lines 10la and 101b, respectively, to permit them to be pushed out of the plane of the bottom panel wall section 101, and to engage the ends of the outer portions 103b, 105b, respectively, of the end wall panel sections 103 and 105.

Such cut-outs may also serve as spacers for spacing panel section 107 from bottom wall section 101 in the folded condition of the sheet 100.

The kit illustrated in Figs. 8-11 may also include the same contents, and may also be used in a similar manner, as described above with respect to the kit of Figs. 1-7, except in this case the specimen card 110 would be carried by panel section 107 of folded sheet 100, rather than by a separate unit in the Figs. 1-7 kit. The kit illustrated in Figs. 8— 11 has the medical desiccant glued to the bottom panel wall section 101 to prevent it from moving around during transport.

While the invention has been described with respect to the two preferred embodiments illustrated in the drawings, it will be appreciated that many other variations,

Le 15 modifications and applications of the invention may be made. For example, the kit could : include collection cards for fewer than three spots, e.g., one or two spots, or for a larger : number of spots, e.g., four or five spots. In addition, some of the contents of the kit could ; be omitted, or others added, according to the particular application for the kit. Many other g variations, modifications and applications of the invention will be apparent.

Claims (19)

I oL__ 14 WHAT IS CLAIMED IS:

1. A kit for use in the collection of a fluid sample from a subject in order to perform a dried fluid spot (DFS) test thereon, comprising: an outer housing including an article holder within the outer housing; and a DFS collection card to be removably held on the article holder within the outer housing; the DFS collection card having an absorbent region for receiving the fluid sample to be tested; the outer housing being openable and closeable and constructed such that, when closed with the article holder received therein, it can be used as a container for forwarding the DFS collection card to a testing facility for testing the fluid sample.

2. The kit according to claim 1, wherein said article holder is a separate unit from the outer housing and is removably received therein when the outer housing is closed.

3. - The kit according to claim 2, wherein the outer housing is constructed to have its opposite ends open for slidably receiving the article holder; and wherein the : article holder is constructed with end walls closing the open ends of the housing, when : the article holder is received therein, to thereby enable the housing with the article holder : therein, to serve as the container for forwarding the DFS collection card to a testing facility for testing the fluid sample.

4. The kit according to claim 1, wherein said outer housing includes a flat sheet formed with a plurality of fold lines defining sections which are foldable with respect to each other into a box configuration, one of said sections being constructed to serve as said article holder for removably holding the article within the outer housing.

5. The kit according to claim 4, wherein said one section serving as said article holder is constructed as a panel to be folded between two sections of the kit serving as top and bottom walls of the outer housing in the folded condition of the flat sheet.

6. The kit according to claim 5, wherein said one section constructed to serve as said article holder is formed with slits arranged to receive corners of said DFS collection card.

E 15

7. The kit according to claim 1, wherein said outer container further includes a desiccant for dehumidifying the container and the DFS collection card therein when forwarding the container to the testing facility.

8. The kit according to claim 1, wherein the outer container further includes one or more bar code labels for application to the DFS collection card and/or article holder to identify the fluid sample thereon.

9. The kit according to claim 1, wherein said absorbent region in the DFS collection card includes a first area for receiving a quantity of the fluid sample, which first area is defined by weakened lines to facilitate removal of the first area and testing the fluid sample thereon.

10. The kit according to claim 9, wherein said absorbent region in the DFS collection card includes a second area for receiving another quantity of the fluid sample, which second area is defined by weakened lines to facilitate removal of the second area and testing the fluid sample thereon. ’

11. The kit according to claim 10, wherein the first and second areas are of ‘ circular configuration.

12. The kit according to claim 10, wherein the absorbent region in the DFS 2 collection card includes a third area for receiving a further quantity of the fluid sample.

13. The kit according to claim 1, wherein said outer housing further includes a disposable lancet for piercing the skin of the subject in order to draw blood therefrom.

14. The kit according to claim 13, wherein said outer housing further includes an alcohol pad for use in disinfecting the skin of the subject before and/or after pierced by the lancet.

15. The kit according to claim 14, wherein said outer housing further includes a gauze pad for application over the subject’s skin after blood has been drawn therefrom.

16. The kit according to claim 1, wherein said outer housing further includes a pair of tweezers for manipulating the absorbent region after receiving a quantity of the fluid sample.

17. A method of collecting a fluid sample from a subject in order to perform a dried fluid spot (DFS) test thereon comprising the use of the kit defined in any one of claims 1-16.

18. A kit for use in the collection of a fluid sample from a subject in order to perform a DES test thereon, substantially as described with reference to and as illustrated in Figs. 1-7 or 8-11 of the accompanying drawings.

19. A method for the collection of a fluid sample from a subject in order to perform a DFS test thereon, substantially as described with reference to and as illustrated in Figs. 1-7 or 8-11 of the accompanying drawings. DATED THIS 10" DAY OF FEBRUARY 2011 DESSINGTON DE BEER FOR THE APPLICANT