Method for sample analysis in an automatic analyser

Abstract

A foil and its use in a method for analyzing a sample in an automatic analyzer, comprising the steps of providing foil comprising at least one immobilized reagent; forming the foil to a receptacle; adding the sample to the receptacle; and analyzing a reaction between sample and immobilized reagent.

Claims

1. A method for analyzing a sample in an automatic analyzer, comprising the steps of: a) providing foil comprising at least one immobilized reagent b) forming the foil to a receptacle; c) adding the sample to the receptacle; and d) analyzing a reaction between sample and immobilized reagent.

2. The method according to claim 1, wherein a step of immobilizing the reagent onto the foil is performed into the same device that will subsequently perform steps a) to d) of claim 1.

3. The method according to claim 1, wherein the foil is formed to a pipette tip, tube, cavity, bottle, well or multi-well.

4. The method according to claim 1, wherein forming the foil comprises a thermal deformation or a winding process.

5. The method according to claim 1, wherein immobilization of the reagent is performed by printing the reagent onto the foil.

6. The method according to claim 1, wherein analyzing a reaction comprises detecting an immune, chemical or enzymatic reaction.

7. The method according to claim 6, wherein detecting a chemical or enzymatic reaction comprises initiating an immune, fluorescence or a luminescence reaction.

8. The method according to claim 1, wherein adding a sample is a result of using a foil formed to a pipette tip for transfer of the sample.

9. The method according to claim 1, wherein the sample is added to a foil formed to a receptacle for carrying out the analyzing step.

10. The method according to claim 1, further comprising the step of printing at least one hydrophilic and at least one hydrophobic area onto the foil, before forming the foil.

11. The method according to claim 10, comprising the step of printing the hydrophobic area around the hydrophilic

12. The method according to claim 1, comprising the step of providing a foil at the sample area that is located at the tip of the receptacle and a reaction area comprising the reagent, wherein the sample area and the reaction area are connected by a channel and the reaction area is connected by a further channel to a waste area so that the sample can flow from the sample area to the reaction area further to the waste area.

13. A foil comprising at least one immobilized reagent, wherein the foil is made of a material allowing to form it into a receptacle.

14. The foil of claim 13, comprising at least one hydrophilic area and at least one hydrophobic area, wherein the at least one hydrophobic area surrounds the at least one hydrophilic area.

15. The foil of claim 13, wherein multiple hydrophilic areas are connected by channel.

16. The foil of claim 13, wherein a first hydrophilic area is intended for taking up a sample and a second hydrophilic area comprises the at least one immobilized reagent.

17. The foil of claim 16, wherein a third hydrophilic area is a waste area for taking up residues from a chemical or enzymatic reaction within the second hydrophilic area.

18. The foil of claim 13, wherein the foil is formed to a pipette tip, tube, cavity, bottle, well or multi-well.

19. A method of using a foil comprising at least one immobilized reagent, wherein the foil is made of a material allowing to form it into a receptacle comprising the step of providing the foil in an automated analyzer system for analyzing samples.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0032] The invention will now be described with reference to the figures. It will be understood that the embodiments and aspects of the invention described in the figures are only examples and do not limit the protective scope of the claims in any way. The invention is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the invention can be combined with a feature of a different aspect or aspects of other embodiments of the invention. It shows:

[0033] FIG. 1 is a top view schematic of a foil used in the method for sample analysis according to the first embodiment of the invention.

[0034] FIG. 2 is a perspective view schematic of the foil of FIG. 1 formed to a tube.

DETAILED DESCRIPTION OF THE INVENTION

[0035] The invention provides a method for sample analysis in an automatic analyzer enabling a simplified and customized sample analysis. The present invention does neither refer to a complex microfluidic device nor to a simple approach that is comparable to paper chromatography. The disclosed method can be implemented into automated analyzer systems for simplifying assays. The reagent to be immobilized can be chosen depending on the assay to be performed. Such assay can be immunoassays where it is necessary to use the specific reagents depending on the antigen to be detected or verified.

[0036] The term foil shall be understood within the meaning of the present disclosure as relating to a thin sheet or thin layer of a material that may be selected from the group of paper, metal, plastic, synthetic or biological prepared material, glass and aluminum. A foil represents a thin matrix of such materials that may be soaked or comprise a liquid.

[0037] An immobilized reagent within the meaning of the present invention comprises an immobilized solid, powder or liquid, also a dried liquid, comprising an analyte, buffer, reagent, solution, beads in solution and a mixture of liquid and solids. The immobilized reagent may also encompass a coating or a partial coating of the foil.

[0038] The words channel and drain are used synonymously for a liquid connection between two hydrophilic areas for instance.

[0039] A receptacle within the meaning of the present disclosure refers to a pipette tip, tube, cavity, bottle, well or multi-well which does not allow capillary forces to take effect.

[0040] A sample analysis process comprises the steps of providing consumables and at least one sample in a liquid state to the automatic analyser, bringing the sample together with at least one reagent, and analysing if at least one analyte in the sample reacts with the reagent.

[0041] The step of providing can be a loading process. The sample may comprise at least one analyte, wherein the analyte can react with at least one reagent in an enzymatic or chemical color change reaction or in a light emitting chemical or enzymatic reaction such as a luminescence or a fluorescence reaction, wherein a fluorescence reaction is a type of luminescence reaction characterized by emitting fluorescent light. The sample may further comprise a solvent, a fluxing agent, anticoagulant, preservative and/or a buffer. The reagents may be selected from the group comprising but not limited to: dried immuno-conjugates, enzymes, enzyme substrates, primers, nucleotides, dyes, DNA and/or RNA molecules comprising a quencher and/or a reporter and antibodies possibly linked to a reporter molecule or another reagent. Consumables may be selected from the group comprising but not limited to: solvents, glue, hydrophobic material, hydrophilic material, matrices, reagents, pipette tips, receptacles and reaction vessels such as cuvettes, tubes, multi well plates, glue.

[0042] Standard components pre-printed on a foil according to the invention shall be selected from the group comprising but not limited to: hydrophilic material, hydrophobic material, glue, fixing agents, and enzyme substrates. In a dissolving process bonds between elements of a compound to be solved are replaced by bonds to a solvent molecule.

[0043] The invention describes a method for sample analysis in an automatic analyzer comprising the steps of providing a liquid sample and a foil comprising at least one immobilized reagent to the automatic analyzer, forming the foil to a receptacle, pipette tip or tube or forming at least one cavity in the foil; bringing the at least one reagent in contact with a liquid sample, wherein the reagent is dissolved by the sample; and analyzing if at least one analyte in the sample reacts with the reagent. The forming step of the foil may be carried out in the automatic analyser in a thermal deformation or winding process. The foil may consist of a foil material on reels or foil material stripes. Alternatively, the foil in the providing step does not comprise the immobilized reagent or is pre-printed with standard components and the method further comprises an immobilizing step before the forming step, wherein at least one reagent is immobilized on the foil. The immobilization step may be achieved by printing the reagents onto the foil. The printing step can be carried out by standard inject printer's technology. The foil can for example be supplied in a flat form on a roll or in a cartridge in the providing step. It is new and preferred that the immobilization process takes place on-the-fly in the automatic analyser, because it enables the production of a customized foil. The foil may be pre-printed with standard components, so that only the desired reagents are printed onto the foil inside the automatic analyser. Alternatively, the immobilization process can take place outside the automatic analyser in an upstream production step.

[0044] In a first embodiment, the foil is further printed with hydrophobic and hydrophilic material so that it comprises at least one hydrophobic area surrounding at least one hydrophilic area. The hydrophilic area comprises at least one sample area, one reaction area and one waste area, wherein the sample area is connected to the reaction area by a first channel and the reaction area is connected to the waste area by a second channel and wherein the reaction area comprises immobilized reagents. After the immobilization process, the foil is formed to a tube and sample is applied to the sample area by immersing the sample area in the sample by dipping the tip of the tube on the respective side into the sample. Due to the hydrophilic and hydrophobic surface properties, respectively, the sample follows the hydrophilic path and automatically flows from the sample area over the first channel to the reaction area and further over the second channel to the waste area. Once arrived in the reaction area, the sample reacts with the reagent in a light emitting chemical or enzymatic reaction. The analyzing step can directly be carried out on the tube without using further reaction vessels or any other receptacle. Moreover, no pipettor, pipetting pump or pipette tips are necessary, if a picker arm is used to dip the tip of the foil into the sample. The number of different reactions can be varied by varying the number of reaction areas. The tube can be formed in a way that the reagents and the hydrophobic and hydrophilic areas are on the outside of the tube or on the inside of the tube. If the reagents and the hydrophilic and hydrophobic areas are on the outside of the tube or as soon as the tube diameter is big enough, it is convenient to have multiple hydrophilic areas each comprising a reaction area. If the reagents and the hydrophilic and hydrophobic areas are on the inside of the tube, the diameter of the tube needs to be big enough to avoid capillary forces and to avoid that a sample drop touches and thereby connects multiple reaction areas.

[0045] In a second embodiment, the foil is formed to a pipette tip, wherein the pipette tip can directly be used to take up the sample from the sample storing or sample transporting receptacle by aspiration. The formed pipette tip therefore functions as reaction vessel at the same time, wherein the reagents react with analyte in the sample to be detected. The analysing step can therefore be carried out inside the pipette tip or in a reaction vessel such as a cuvette or tube. It is new that a pipette tip can be used as reaction vessel.

[0046] In a third embodiment, the foil is formed to a reaction vessel and the reagents may be re-suspended by adding a solvent or another liquid before adding the sample. The analyzing step is then carried out in the formed reaction vessel, wherein the reaction vessel may have the form of cuvette.

[0047] In a fourth embodiment at least one reagent comprising cavity is formed into the foil. The sample is applied to at least one cavity, for example with a pipettor, where the reagents can react with an analyte in the sample.

[0048] The advantages of the invention of the present disclosure can be summarized as follows: [0049] a. The invention allows to reduce the costs, loading effort and space by using less pipette tips and receptacles. [0050] b. The invention allows to use a pipette tip as a reaction vessel [0051] c. The invention allows to avoid extra pipetting steps. [0052] d. The invention does not necessarily need a pipettor. [0053] e. The invention allows for customization of the reagents immobilized on the foil in the automatic analyser.

[0054] FIG. 1 shows a top view of a foil 1 according to the first embodiment for carrying out three analyses, comprising three hydrophilic areas 7 surrounded by a hydrophobic area 6, wherein each hydrophilic area comprises a sample area 2 connected by a channel 5 to a reaction area 3 connected by a channel 5 to a waste area 4.

[0055] FIG. 2 shows a perspective view of half of the assay foil of FIG. 1 formed to a tube.

[0056] The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment was chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.

REFERENCE NUMERALS

[0057] 1 assay foil [0058] 2 sample area [0059] 3 reaction area [0060] 4 waste area [0061] 5 channel [0062] 6 hydrophobic area [0063] 7 hydrophilic area