SYSTEM FOR SINGLE-USE IMMUNOCHEMICAL TESTS

Abstract

A system for single-use immunochemical tests, comprising a support equipped, along a main direction, with a plurality of housings, including —at least one first housing for the sample to be analyzed, —at least one second housing for substances to be combined with the sample during the test, —at least one third housing for a well carrying a substance to be combined with the sample during the test, characterized in that the surface of said at least one third housing of said support is opaque to light and said well is made of a material at least partially transparent to light, and in that said at least one third housing is —equipped with a through-hole on the bottom, so that a beam of light can pass through said bottom of the third housing and through said well, in order to conduct a colorimetric absorbance test, or —equipped with a closed bottom in order to conduct a luminescence test in the well, —so that said system uses a single type of well at least partly transparent to light to conduct colorimetric absorbance and luminescence tests.

Claims

1. A system for single-use immunochemical tests, comprising: a well, carrying a substance to be combined with the sample during the test; and a support, equipped along a main direction, with a plurality of housings, comprising at least one first housing for the sample to be analyzed, at least one second housing for substances to be combined with the sample during the test, at least one third housing for said well carrying a substance to be combined with the sample during the test, wherein the surface of said at least one third housing of said support is opaque to light and said well is made of a material at least partially transparent to light, and in that said at least one third housing is equipped with a through-hole on the bottom, so that a beam of light can pass through said bottom of the third housing and through said well, in order to conduct a colorimetric absorbance test or equipped with a closed bottom in order to conduct a luminescence test in the well, so that said system uses a single type of well at least partly transparent to light to conduct colorimetric absorbance and luminescence tests.

2. The system for single-use immunoenzymatic tests according to claim 1, wherein the entire surface of said support is opaque to light.

3. The system for single-use immunoenzymatic tests according to claim 1, wherein all of said support is made completely from a material opaque to light.

4. The system for single-use immunoenzymatic tests according to claim 1, wherein at least the surface of said at least one third housing of said support is black.

5. The system for single-use immunoenzymatic tests according to claim 1, wherein the entire surface of said support is black.

6. The system for single-use immunoenzymatic tests according to claim 1, wherein said support extends prevalently in a main direction and has, at one end, an engagement tab and, subsequent thereto, in succession one said first housing, with a closed bottom, adapted to contain the sample to be analyzed, a group of at least three, preferably four, second housings in succession, equipped with a bottom and adapted to contain substances, at least said two third housings, preferably two, adapted to contain respective said transparent wells, said at least one fourth housing, preferably one.

7. The system for single-use immunochemical tests according to claim 6, wherein said at least one fourth housing has no bottom.

8. The system for single-use immunochemical tests according to claim 1, wherein said at least one second housing is closed at the top by a film fixed to said support.

9. A kit structure for immunoenzymatic tests comprising the components of the system according to claim 1.

10. A method for the preparation of a single-use immunochemical test for a sample to be analyzed, the method comprising: providing a well made of a material at least partially transparent to light carrying a substance to be combined with the sample during the test, and if the immunochemical test is of colorimetric absorbance type, providing a support equipped, along a main direction, with a plurality of housings, including at least one first housing for the sample to be analyzed, at least one second housing for substances to be combined with the sample during the test, at least one third housing for said well carrying a substance to be combined with the sample during the test, wherein the surface of said at least one third housing of the support is opaque to light and moreover the at least one third housing is equipped with a through-hole on the bottom, so that a beam of light can pass through the bottom of the third housing and through the well, in order to conduct the colorimetric absorbance test, if the immunochemical test is of luminescence type, providing a support equipped, along a main direction, with a plurality of housings, including at least one first housing for the sample to be analyzed, at least one second housing for substances to be combined with the sample during the test, at least one third housing for said well carrying the substance to be combined with the sample during the test, wherein the surface of said at least one third housing of the support is opaque to luce and said third housing is also equipped with a closed bottom in order to conduct a luminescence test in the well, so that the method uses a single type of well at least partly transparent to light to conduct colorimetric absorbance and luminescence tests.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] The invention will be better understood by following the description and accompanying drawings, which illustrate a non-limiting example of embodiment of the invention. More in particular, in the drawing:

[0059] FIG. 1 represents a schematic side view of a transparent well for the kit structure according to the invention;

[0060] FIG. 2 represents a schematic side view of a support for wells, opaque, for the kit structure according to the invention;

[0061] FIG. 3 represents a schematic top view of the support for wells of FIG. 2;

[0062] FIG. 4 represents a cross-sectional schematic side view of a support for wells, opaque, for the kit structure according to the invention, in which the housings of the wells (shown in an exploded view) are equipped with a closed bottom in order to conduct luminescence, for example chemiluminescence, tests;

[0063] FIG. 5 represents a cross-sectional schematic side view of the support for wells, opaque, as in FIG. 2, in which the housings of the wells (shown in an exploded view) have no bottom in order to conduct colorimetric tests,

DETAILED DESCRIPTION OF EMBODIMENTS

[0064] With reference to the aforesaid figures, a system, i.e., a kit structure for single-use immunoenzymatic tests according to the invention, is indicated as a whole with the number 10. This structure is adapted to interact with machines that operate in a known manner.

[0065] This kit structure 10 comprises a support 11, such as a body made of plastic material (for example polypropylene), in one piece, produced by molding.

[0066] The support surface 11 is entirely opaque to light and is preferably black.

[0067] This support 11 extends prevalently in a main direction and has, at one end, an engagement tab 12 and, subsequent thereto, a plurality of housings for the various substances to be used for the test.

[0068] In particular, immediately subsequent to the engagement tab 12 is a first housing 13, with a closed bottom, adapted to contain the sample to be analyzed.

[0069] Subsequent to the first housing 13 is a group of four second housings in succession, indicated with 14A, 14B, 14C, 14D, equipped with a bottom and adapted to contain substances useful for the test, such as substrate, conjugate, stop solution and diluent of the samples.

[0070] These second housings 14 are advantageously closed at the top by a film 15 heat sealed to the support 11 and which is adapted to be pierced during the test for the collection of substances by the machine with which the support interacts.

[0071] Downstream of the second housings 14 are two third housings 16 in succession, adapted to contain respective wells 17 containing substances to be combined during the test, such as specific antigens/antibodies related to the test to be conducted.

[0072] In this example (FIG. 4), the test is of luminescent, for example chemiluminescent, type and the third housings 16 have respective bottoms 16A, i.e., are open only at the top, at the mouth through which the wells 17 are inserted.

[0073] Downstream of the third housings 16 is a fourth housing 18, with no bottom, for containing a possible additional reagent.

[0074] The wells 17 are made of a plastic material transparent to light, such as polystyrene. They are cup shaped in order to be snap fitted into the third housings 16 and have a ring of teeth 19 to facilitate snap-fitting coupling with these housings.

[0075] In this example, the single-use test kit, as said, allows chemiluminescence determination to be carried out. By introducing luminol (for example collected from one of the second housings 14) in the wells 17 inserted in the third housings 16), this reacts with the antigens/antibodies present therein (following suitable treatment with other substances always present in the second housings), and a chemiluminescent reaction occurs, which is measured with a suitable photometer present in the machine with which the support interacts, positioned above the third housing. The well 17 is transparent, the third housing 16 into which it is inserted is completely opaque to light and therefore there is no light interference from outside and from the adjacent well, which would distort the test result.

[0076] FIGS. 2, 3 and 5 show the case of a single-use test kit for a determination of colorimetric type. The only difference compared to the example described above lies in the bottoms of the third housings 16.

[0077] In practice, in this example, the wells are the same as those described above, i.e., are made of a material transparent to light, and are therefore indicated with the same number 17. The support for the wells is also substantially the same, with the sole difference that the third housings (now indicated with 116) have no bottom 16A, and is indicated with the number 111.

[0078] The fact that the third housings 116 have no bottom allows the passage from below of beams of light adapted to strike the content of the wells 17 in these housings and reading, by means of the photometer above, of the absorbance of the colored solution in the wells.

[0079] In practice, the kit structure according to the invention allows the use of transparent wells also for those tests for which in the past opaque wells were used as it was necessary to isolate the wells from the external light.

[0080] This way possible using supports with surfaces, at least the surface relating to the housings adapted to receive the wells, that are opaque, so as to surround the wells by means of an opaque interface that isolates them from non-operational external light.

[0081] This solution makes it possible to have an inventory (and hence a stock) only of wells of transparent type, containing the substances required for the determinations. When the test to be conducted is of colorimetric type, the transparent well is inserted in the housing with no bottom of an opaque support, so that the test can be conducted without limitations. When the test to be conducted is of luminescent, for example chemiluminescent, type, the transparent well is inserted into the housing with a closed bottom of a support with opaque surface.

[0082] It is understood that above illustration represents only possible non-limiting embodiments of the invention, which can vary in forms and arrangements without departing from the scope of the concept on which the invention is based. The presence of any reference numbers in the appended claims is for the sole purpose of facilitating the reading thereof in the light of the foregoing description and of the accompanying drawings and in no way limits the scope of protection.