Transportable test machine for detecting the presence of an antigen in a sample of biological material

Abstract

Transportable test machine (M) for detecting the presence of an antigen in a sample of biological material, comprising: - a test chamber (3) accessible through a window (2); - a seat (7a) for a tray (V) arranged in the test chamber (3), such tray having at least one sequence of recesses (RO, R1, R2) arranged longitudinally and containing biological test substances; - a motorized membrane holder support (12) arranged in the chamber (3) at a greater vertical height than the seat (7a) so as to be movable upon translation parallel to the sequence of recesses of the tray and vertically with respect to such seat, and the motorized membrane holder support (12) being configured to carry in use a paddle (P) with a functionalized membrane (15) on board on which selective biological molecules are located to select and anchor said antigen to the membrane; and the motorized membrane holder support (12) being also connected in data exchange to an electronic control unit programmed to: ▪ actuate the motorized membrane holder support (12) on the basis of a predefined position variation law to sequentially immerse the functionalized membrane in the recesses of a sequence of recesses of the tray (V) arranged in use in the seat (7a); . receive an image of the functionalized membrane; . process the image by counting the bioluminescent pixels so as to provide a quantitative result of the bioluminescent effect.

Description

[0001] TRANSPORTABLE TEST MACHINE FOR DETECTING THE PRESENCE OF AN ANTIGEN IN A SAMPLE OF BIOLOGICAL MATERIAL

[0002] DESCRIPTION

[0003] TECHNICAL FIELD

[0004] The present invention relates to the field of rapid diagnosis, particularly to a test machine for automated rapid diagnosis that can also be used outside of specialized laboratories, such as in pharmacies or other first-aid centers, providing an immediate bioluminescent response or using a digital reader for diagnosis and / or risk prediction. Preferably, through this device, it is possible to process cellular extracts of certain markers using immunological assays, and it is possible to employ the ELISA procedure (enzyme-linked immunosorbent assay).

[0005] STATE OF THE ART

[0006] Known 'patient side' diagnostic devices utilize chemicolorimetry for the immediate detection of markers present in cellular extracts. Although chemicolorimetry has numerous advantages, it is, at least in some cases, relatively difficult to repeat consistently and overly dependent on the operator who reads and interprets the chemichromatic result. Furthermore, currently available rapid diagnostic devices are used by specialized personnel within analysis laboratories, e.g., within hospitals, requiring the patient to visit specialized facilities to undergo the diagnostic test, sometimes traveling long distances since such facilities may not be present in the urban center where the patient resides. Moreover, being produced by specialized personnel within dedicated laboratories, the diagnostic tests currently employed are costly and have long processing times before the patient receives the results, leading to delays in providing necessary treatment if the test shows negative results for the patient's health. The diagnostic tests currently performed involve numerous manual activities by laboratory operators, e.g., mixing reagents, transferring the solution with the biological sample from one container to another, etc., thus lengthening the test execution time and increasing the likelihood of errors.

[0007] Therefore, there is an ongoing need to create 'patient side' diagnostic devices that can also be used outside specialized facilities, e.g., pharmacies or first-aid centers, which are more affordable and at the same time reduce processing times and the time it takes to receive test results.

[0008] OBJECT AND SUMMARY OF THE INVENTION

[0009] The present invention aims to address at least some of the above-mentioned needs, wherein this aim is achieved through a test machine as defined in claim 1.

[0010] According to a preferred embodiment of the present invention, a portable test machine is described for detecting the presence of an antigen in a sample of biological material taken from a patient, e.g., biological molecules from an oropharyngeal swab. Specifically, through this machine, it is possible to perform an automated test capable of producing a bioluminescent result following operations carried out sequentially to make the biological sample interact with biological substances present in a test tray arranged for use inside the machine. In this way, it is possible to create a machine that exploits both the advantages of bioluminescence, i.e., greater precision and uniqueness of interpretation, and the availability of a precise tool that can be used outside of analysis laboratories and is capable of providing test results quickly and at significantly reduced costs, in order to promptly deliver the necessary treatment to the patient in case the test is negative for the patient's health, compared to other known solutions that require longer processing of the biological material sample, such as in analysis laboratories. To achieve this result, the portable test machine described here includes a test chamber accessible through a window, e.g., the test machine is a box-like body having an opening through which the chamber can be accessed. In use, within this test chamber, particularly within a seat for a test tray, a tray is arranged carrying biological substances to be processed sequentially, particularly, the tray presents a longitudinal sequence of recesses, preferably a plurality of longitudinal sequences of recesses to perform multiple tests in parallel, containing biological substances capable of generating a bioluminescent effect when mixed together. The tray may be made of thermoformed plastic material, e.g., polystyrene, and may be provided as part of a kit that includes a brush and additional biological test substances contained in specific containers. The recesses of the tray may be sealed with a peel-off closure or caps that, during the preparation of the test tray outside the machine, are removed, and the biological material sample taken from the patient is introduced into one of these recesses, preparing the tray for the test. According to a further aspect of the present invention, the portable test machine includes a motorized membrane holder arranged in the chamber at a vertical height greater than the seat of the test tray, so that it is movable to translate parallel to the sequence of recesses of the tray and vertically with respect to that seat of the tray. Specifically, this motorized membrane holder is configured to carry in use a palette with a membrane functionalized on which selective biological molecules to capture and anchor the antigen to the membrane are localized. To achieve this result, the membrane holder preferably includes a pocket for holding the palette, facing the tray seat. For example, the palette is an elongated body with a first end fixed to the membrane holder in use and a second end, longitudinally opposite to the first end, on which the functionalized membrane is mounted. According to a further aspect of the present invention, the motorized membrane holder is also connected to a data exchange system with an electronic control unit programmed to: act on the motorized membrane holder based on a predefined position variation law to sequentially immerse the functionalized membrane in the recesses of a sequence of recesses in the tray used in the tray seat. For example, the membrane holder may be actuated by electric motors, which in turn are connected to motion transmission mechanisms from rotation to translation, e.g., lead screw and nut., so that the rotation of the electric motor causes a translation of the membrane holder; receive an image of the functionalized membrane containing the bioluminescent effect; process the image by counting the bioluminescent pixels to provide a quantitative result of the bioluminescent effect. Preferably, the portable test machine includes an image acquisition device also disposed within the chamber in a position longitudinally opposite to the window with respect to the tray seat, so as to be able to acquire images of the bioluminescent result once the biological test substances in the tray recesses and the functionalized membrane have been processed. Preferably, the electronic control unit is located outside the test machine, e.g., on a computer inside the laboratory or pharmacy where the machine is located, and this electronic control unit can be connected for data exchange with the test machine. In this way, once the last station of recesses on the tray is reached, the membrane holder is actuated to translate vertically and immerse the functionalized membrane in the mixture contained in the last recess. In this position, the image acquisition device is actuated to acquire an image of the palette, which is subsequently processed to perform a quantitative analysis of the bioluminescent effect.

[0011] DESCRIPTION OF FIGURES

[0012] The structural and functional characteristics of the transportable test machine can be better understood from the following detailed description, with reference to the attached figures which represent a preferred and non-limiting embodiment, in which:

[0013] • Fig. 1 shows an axonometric view of the test machine according to a preferred embodiment of the present invention; • Fig. 2 shows an axonometric view of the test machine of Fig. 1 with the test material support shuttle extracted from the test chamber;

[0014] • Fig. 3 shows a side view of the test machine of Fig. 2;

[0015] • Fig. 4 shows a side view of the test machine of Fig. 1;

[0016] • Fig. 5 shows a front view of the test machine of Fig. 1;

[0017] • Fig. 6 shows a top view of the test machine of Fig. 1;

[0018] • Fig. 7 shows a schematic view of a paddle with a functionalized membrane onboard.

[0019] DETAILED DESCRIPTION OF THE INVENTION

[0020] According to a preferred embodiment of the present invention, in Figures 1—6 a transportable test machine M is illustrated as a whole, which is used to detect the presence of an antigen within a sample of biological material taken from a patient. The test machine M has dimensions and weight such as to be liftable and manually transportable by a user and positionable on a support surface such as, for example, a table of a laboratory or of a pharmacy. In particular, such test machine comprises a body 1, preferably box-shaped, on which a window 2 is made transversely and preferably perpendicularly to the support plane of the machine, through which it is possible to access a chamber 3 arranged inside the body and in which, in use, an automated diagnostic test of the sample of biological material is carried out. Preferably, the test machine M comprises a shuttle 4 which is used to introduce inside the chamber 3, through the window 2, the sample of biological material to be examined contained in a test tray V (Fig. 3) together with other biological substances suitable to generate a bioluminescent effect when mixed with each other. Such shuttle 4 is movable parallel to a transverse axis XI and preferably perpendicular to the direction of extension of the window 2. In particular, the shuttle 4 is movable between an extracted position in which it is at least partly extended outside the window 2 (Figs. 2 and 3), and a retracted position (Figs. 1 and 4) in which it is arranged inside the chamber 3, presenting an end shaped on the side of the window 2 which closes the latter blocking the access of light into the chamber from the external environment of the test machine M. For example, the end of the shuttle may comprise a lid 5 which engages in a recessed seat 5a made on the body 1 around the window 2 (Fig. 2). Preferably, inside the chamber 3, guides 6 are arranged on which the shuttle 4 engages so as to be movable by translation parallel to the axis XI. Preferably, the shuttle 4 may be motorized so that extraction and insertion thereof into the chamber 3 can be actuated automatically. For example, an electric motor 6a may be provided, connected in torque transmission to a belt transmission in turn connected to the shuttle 4, so that a rotation of the electric motor causes a translation of the shuttle parallel to the axis XI. Moreover, on board the shuttle 4 a support 7 is made defining a seat 7a for a test tray and arranged along at least one portion of the shuttle. In particular, such support extends projecting upwardly from the shuttle. For example, the support 7 may comprise a plurality of fins, preferably rectangular, longitudinally spaced from one another and extending vertically from the shuttle 4 so as to have an end which can be used in use as a support edge for a test tray V in which the sample of biological material to be analysed is deposited, i.e. such tray in use is supported on the fins. Preferably, the test tray V is made of thermoformed plastic material, e.g. a polystyrene film, presenting recesses arranged longitudinally in sequence so as to define test stations on board the tray. Moreover, each test station comprises a plurality of recesses extending transversely and preferably perpendicularly to the direction of extension of the test tray V.

[0021] When the test tray V is arranged on board the support 7, the recesses extend longitudinally towards the guides of the shuttle 4. Therefore, the construction configuration of the support 7 is used so as to keep the test tray V, and in particular the recesses, vertically spaced from the shuttle 4, so that a recess of the test tray, projecting towards the shuttle when the tray is positioned on the support, does not contact such shuttle preventing correct positioning thereof on the support 7. Moreover, the test tray V is arranged on the support 7 so that each fin is interposed between two longitudinally consecutive recesses, and this contrasts in use the relative longitudinal movement of the tray with respect to the shuttle 4, since the vertical wall of the fin interposed between the two recesses defines a contrasting surface. The test tray V may be supplied to the user included in a kit with the recesses closed, each containing test substances such as, for example, liquids and dried materials, containers of reagent liquids to be introduced into the recesses containing the dried materials during the preparation phase of the tray before carrying out the test, and a swab for mixing such substances (not shown in the figures). Preferably, each recess contains a dosed quantity of liquid, e.g. loaded by an operator when the tray is outside the machine before performing the test, e.g. on a laboratory table, or the tray may be supplied to the operator with the recesses closed, e.g. by means of a peelable film, preferably manually peelable, or with recess closing caps, such recesses each containing a pre-dosed quantity of liquid at the time of manufacture of the tray by the producing factory. For example, the geometry of each recess on the test tray V is made so that each recess can contain a dosed or pre-dosed quantity of liquid, e.g. 400—600 microliters. Preferably, preparation of the test tray V may be carried out outside the machine, e.g. on a laboratory table, or on board the machine by positioning the test tray V on board the support 7 after having brought the shuttle 4 into the extracted position outside the chamber 3. In particular, the test tray V comprises an initialization recess R0, preferably a plurality of initialization recesses R0, in which a mixture of initialization substances of the sample of biological material containing the target antigen is contained, such mixture comprising a protease inhibitor and a lysis solution preferably based on saline buffers. When the test tray is positioned on board the support 7, a user may introduce into such initialization recess R0 the test biological material sample containing the target antigen once taken from a patient, e.g. biological molecules deriving from an oropharyngeal swab. Preferably, such operation may also be carried out outside the test machine M, and then the tray ready for the diagnostic test is positioned on board the support 7. Once the sample of biological material has been introduced into the initialization recess RO, it is mixed with the mixture of initialization substances, e.g. using the swab supplied in the kit. Downstream of the initialization recess RO, the test tray comprises a first recess Rl, preferably a plurality of first recesses Rl, in which there are contained in a monophase liquid state a selective biological molecule, for example an antibody, capable of selectively interacting with a target antigen so as to bind also to multiple parts of the same antigen, and a molecule, e.g. biological such as a peroxidase enzyme HRP, catalysing a chemical reaction which generates a bioluminescent substance bound to the selective biological molecule. Furthermore, the test tray V presents downstream of the first recess Rl a second recess R2, preferably a plurality of second recesses R2 arranged transversely with respect to the direction of extension of the test tray, and containing in a monophase liquid state precursors necessary for generating a chemical reaction having a bioluminescent effect and capable of being catalysed by the catalytic molecule contained in the first recess Rl of the longitudinal sequence. For example, the precursors of the substance that generates the bioluminescent effect are hydrogen peroxide and 5-amino-2,3-dihydro- 1,4-phthalazinedione, i.e. luminol. In this way, the content of the first recess Rl and that of the second recess R2 is such both to select and bind with a target antigen and to produce a chemical reaction to generate a substance with a bioluminescent effect bound to the selected antigen. Therefore, on the basis of the construction configuration of the test tray V, the test machine M in turn presents a construction configuration adapted to receive such tray and to carry out an automated test by means of which it is possible to detect the presence of an antigen within a test biological material taken from a patient, in particular by means of the generation of a substance producing a bioluminescent effect bound to the selected antigen. According to a further aspect of the present invention, in order to carry out the above- mentioned test in an automated manner, the test machine M comprises within the chamber 3 a motorized movable head 8 extending transversely to the XI axis and arranged at a greater vertical height than the seat 7. The motorized movable head 8 is rigidly constrained to the translation of the supporting structures 9 which extend vertically in the chamber 3 and are arranged in a position opposite the shuttle 4. Furthermore, these supporting structures 9 are longitudinally movable, i.e., parallel to the XI axis, for example, through motorized guides 10 to which they are fixed (Fig. 5), and this constructional configuration makes the motorized movable head 8 relatively movable to the translation with respect to the shuttle 4 parallel to the XI axis. Furthermore, the motorized movable head 8 has longitudinally opposite ends each connected to a supporting structure 9 so as to be movable vertically, i.e., transversely and preferably perpendicular to the XI axis. In particular, the vertical translational movement of the head 8 causes its approach or retreat from the seat 7, i.e., in use towards or away from the test tray V. In particular, to achieve this result, additional motorized guides 11 (Fig. 3-4) can be provided on the supporting structures 9, in which the longitudinally opposite ends of the motorized movable head 8 are engaged, e.g., defining a screw-nut mechanism. In this way, the actuation of the motorized guides 11 causes a vertical translation of the motorized movable head 8. For example, the ends of the motorized movable head 8 are configured to have a threaded hole engaged in a respective threaded vertical guide 11 connected to an electric motor on the supporting structure 9. Furthermore, the motorized movable head 8 comprises a membrane holder support 12 preferably releasably fixed to the movable head 8, e.g., by screws, so as to extend vertically overhanging in use towards the test tray V on the seat 7. Preferably, this membrane holder support can be made as a single piece with the motorized movable head 8. In particular, this membrane holder support is configured to have at least one functionalized membrane on board containing biologically localized substances that interact sequentially during the automated test with biological substances contained within each recess of a longitudinal sequence of recesses on the test tray V. In particular, the membrane holder support 12 extends parallel to the direction of extension of the motorized movable head 8, with one end projecting towards the seat 7 on which at least one pocket 13 is made (Fig. 5), preferably a plurality of pockets arranged side by side. Each pocket 13 is configured to house a paddle P, shown schematically in Fig. 7, on which a functionalized membrane 15 is arranged. The functionalized membrane, e.g., based on PolyVinylDenFluoride or other materials used in the sector to support antibodies, contains antibodies arranged in localized positions on the membrane so as to bind in use to the antigens present in the initialization recess RO and containing the biological test material comprising the antigen. In particular, the paddle P has a preferably elongated shape and has a first end Pl configured so that it can be rigidly engaged in the pocket 13, and a second end longitudinally opposite to the first, which, in use, is oriented towards the seat 7 bringing the functionalized membrane 15 on board accessible through a window 16 made on opposing faces of the paddle. Preferably, the paddle P can be rigidly fixed in the pocket 13 by interference coupling, or inside the pocket, a locking element (not shown in the figures) can be provided, e.g., a spring, configured to rigidly lock the paddle P once the corresponding first end Pl is engaged inside the pocket. Therefore, once the membrane holder support 12 is prepared with the paddle P on board with the respective functionalized membrane 15, and once the test tray V is positioned on the seat 7 with the biological test material mixed with initialization substances in the initialization recess RO, the machine can be actuated to start the test. Preferably, to facilitate the loading of the paddles P onto the membrane holder support 12, the latter can be removed from the motorized movable head 8 so that the operator can carry out the preparation outside the machine. Once the paddles P are loaded onto the membrane holder support 12, the latter can be re-fixed to the motorized movable head 8. In this way, the chamber 3 can be closed by bringing the shuttle 4 into the retracted position to start the test. In particular, when the test is started, the shuttle 4 is in a predefined position within the chamber 3 with the tray on board the seat 7 and the motorized movable head 8 is movable so that each paddle P on the membrane support 12 is movable over a corresponding longitudinal sequence of recesses. It should be noted that the presence of multiple longitudinal sequences of recesses on the test tray and the presence of a number of paddles corresponding to the number of longitudinal sequences of recesses arranged on the membrane holder support 12 allows performing multiple tests simultaneously. For example, these longitudinal sequences of recesses may contain test biological substances based on different primary antibodies from sequence to sequence. According to a further aspect of the present invention, when the test machine M is actuated, the motorized movable head 8 moves parallel to the XI axis so as to position each paddle P on the membrane holder support 12 above the corresponding initialization recess RO. When the paddle P is above the corresponding initialization recess RO, the motorized movable head 8 is actuated so as to perform a vertical movement that brings the paddle towards the corresponding initialization recess RO, stopping at a height such that the respective functionalized membrane 15 is immersed in the mixture contained in the initialization recess RO. In this way, an interaction occurs between the antibodies on the membrane and the initialization substances containing the biological material comprising the antigen, anchoring them to the functionalized membrane. After a predetermined time known to cause the interaction between the antibodies on the functionalized membrane 15 and the initialization substances, the motorized movable head 8 is actuated again to perform a vertical movement in the opposite direction, so that, by lifting, it moves each paddle P away from the corresponding initialization recess RO, stopping vertically at a height such that the functionalized membrane 15 is disposed outside the mixture contained in that initialization recess. The motorized movable head 8 is actuated again so as to advance parallel to the XI axis so as to position the paddle P above the corresponding first recess R1 and to repeat the operation of immersion of the functionalized membrane 15 in the mixture contained in the first recess Rl, in a known manner. Once this operation has been completed, the motorized movable head 8 translates vertically upwards and then advances parallel to the XI axis so as to position the paddle P above the corresponding second recess R2 and to repeat again the operation of immersion of the functionalized membrane 15 in the mixture contained in the second recess R2. In this manner, the functionalized membrane 15 is sequentially immersed in order to interact with the substances contained in each recess in a known manner. Furthermore, in order to actuate the movement of the motorized movable head 8 as described above, the motorized movable head is connected in data exchange to a control unit preferably on board the test machine M; more particularly, the electric actuation motors of the motorized movable head 8 are connected to such electronic control unit. Preferably, the electronic control unit may also be located outside the test machine, e.g. on board a computer inside the laboratory or the pharmacy in which such machine is located, and is connectable for example via cable to the test machine. In particular, such electronic control unit is programmed to send to such electric motors signals representative of a sequence of position variation laws of the motorized movable head vertically and horizontally in order to sequentially immerse the paddle P in the recesses of the test tray.

[0022] Once the last recess station on the tray has been reached, the motorized movable head 8 is actuated so as to translate vertically towards the support 7 and to immerse the functionalized membrane 15 in the mixture contained in the last recess so as to thus generate the bioluminescent effect. Preferably, the test machine M comprises on board an image acquisition device 16 arranged in a longitudinal position opposite the window 2 with respect to the tray and configured to capture an image of the functionalized membranes 15 with the related bioluminescent effect. It should be noted that the test machine, in a simpler constructional form, may also not comprise the image acquisition device 16, which can be mounted on board separately by the user. Therefore, in order to capture an image of the functionalized membranes, each paddle P is mounted on board the motorized membrane holder support 12 so that the window 16 through which it is possible to access the membrane on the paddle P is facing the image acquisition device 16, and the functionalized membrane 15 is kept immersed below the level of the mixture inside the recess during image acquisition. The image acquisition device may also be located outside the machine, for example inside a dark chamber in the laboratory in which the test is carried out. Alternatively, if not already on board the testing machine, a support of an image acquisition device 17 may be provided on which the user can releasably mount the image acquisition device. Therefore, after the image has been acquired by the image acquisition device, preferably an electronic device, it is possible to carry out a quantitative analysis of the bioluminescent effect. In particular, the electronic control unit is programmed to receive such image and to process it. Preferably, by means of a boundary detection or binarization algorithm it is possible to divide the pixels of the digital image of the functionalized membrane 15 with bioluminescent effect into background pixels (darker) and bioluminescent pixels (lighter), and the latter can be counted. Furthermore, after having been identified, the bioluminescent pixels of the starting image can be classified on the basis of light intensity. Furthermore, preferably, the electronic control unit is connected in data exchange to the image acquisition device and is programmed to perform at least one of the imaging operations described above.

[0023] According to a preferred embodiment of the present invention (Fig. 5-6), the test machine M may include a plurality of shuttles 4, preferably four, arranged in parallel and a corresponding number of membrane holder supports 12 connected to the motorized movable head 8, which in turn in use carry a plurality of paddles P, preferably eight, each with its respective functionalized membrane 15. Advantageously, through this embodiment, it is possible to automatically perform several tests simultaneously, thus enabling the diagnosis test on biological material samples from different patients, resulting in faster test execution and quicker report delivery, while still using a structurally simple, compact, and manually transportable test machine M. Furthermore, to minimize the number of image acquisition devices inside chamber 3, benefiting the overall cost of the machine and weight, the support for the image acquisition device 17 can be onboard the test machine, and in particular, it can be a motorized guide disposed transversely and preferably perpendicular to the XI axis, in which the image acquisition device 16 is engaged so as to be translatable, e.g., via a screw-nut mechanism. In this way, once the image of the functionalized membranes 15 immersed in the first tray VI is acquired, the motorized guide 17 can be activated to move the image acquisition device 16 in front of the functionalized membranes 15 immersed in a second tray V2. Once the image of these functionalized membranes has been acquired, the motorized guide 17 is again activated to move the image acquisition device 16 and repeat the above operations until the images of the functionalized membranes of subsequent test trays are acquired. After acquiring the images of all the functionalized membranes 15, the motorized guide 17 is activated to bring the image acquisition device 16 back in front of the first test tray VI in order to be in position to acquire images of the functionalized membranes of the next diagnostic test. Preferably, in a simplified embodiment not shown in the figures, the test machine M may be without shuttle 4, whereby the seat 7a for the test tray is formed in the chamber 3 and the tray, once ready for the test, is manually positioned by the operator inside such seat.

[0024] According to a further preferred embodiment of the present invention, the test machine M is configured to perform an ELISA procedure in sequences. To carry out this procedure, the test tray V includes at least one primary antibody recess, preferably monoclonal, interposed between the initialization recess RO and the first recess Rl. Additionally, the first recess R1 contains a primary antibody, while the functionalized membrane 15 for sequentially collecting the substances from the recesses carries antigen-specific antibodies from the corresponding monoclonal primary antibodies. These antibodies are in particular polyclonal. The functionalized membrane 15, e.g. based on PolyVinylidene Fluoride or other materials used in the field to support antibodies, has polyclonal non-conjugated antigen-specific antibodies in localized positions in order to bind to the antigens present in the initial solution containing the biological test material.

Claims

CLAIMS1. Transportable test machine (M) for detecting the presence of an antigen in a sample of biological material, comprising: a test chamber (3) accessible through a window (2); a seat (7a) for a tray (V) arranged in the test chamber (3), such tray having at least one sequence of recesses (RO, Rl, R2) arranged longitudinally and containing biological test substances; a motorized membrane holder support (12) arranged in the chamber (3) at a greater vertical height than the seat (7a) so as to be movable upon translation parallel to the sequence of recesses of the tray and vertically with respect to such seat, and the motorized membrane holder support (12) being configured to carry in use a paddle (P) with a functionalized membrane (15) on board on which selective biological molecules are located to select and anchor said antigen to the membrane; and the motorized membrane holder support (12) being also connected in data exchange to an electronic control unit programmed to:• actuate the motorized membrane holder support (12) on the basis of a predefined position variation law to sequentially immerse the functionalized membrane in the recesses of a sequence of recesses of the tray (V) arranged in use in the seat (7a);• receive an image of the functionalized membrane;• process the image by counting the bioluminescent pixels so as to provide a quantitative result of the bioluminescent effect.

2. Testing machine (M) according to claim 1, comprising a shuttle (4) on which the seat (7a) is arranged, and such shuttle being movable between a position extracted from the test chamber (3) in which such seat is outside the window (2), and a second position retracted in such test chamber in which such seat is under the motorized membraneholder support (12) identifying a test position of the tray (V);3. Testing machine (M) according to claim 1 or 2, comprising a support of an image acquisition device (17) on which an image acquisition device (16) can be releasably mounted and can be connected in data exchange to the electronic control unit in order to capture the image of the functionalized membrane, such support being arranged in a longitudinal position opposite the window (2) with respect to the seat (7a) for a tray.

4. Testing machine (M) according to claim 3, comprising an image acquisition device (16) releasably mountable on board the support of an image acquisition device (17).

5. Testing machine (M) according to claim 4, comprising a plurality of seats (7a) placed side by side, and the support of an image acquisition device (17) being motorized so as to be movable for transverse translation with respect to the direction of extension of a sequence of recesses arranged longitudinally on a tray (VI, V2), and furthermore such support of an image acquisition device (17) being connectable in data exchange to the electronic control unit, and the electronic control unit being programmed to actuate the support of an image acquisition device by moving it from a first position in which it is in front of a first tray (V 1) to capture a first image of a functionalized membrane relating to such first tray, to a second position in which it is in front of a second tray (V2) to capture a second image of a functionalized membrane relating to such second tray, the second tray being subsequent to the first tray.

6. Testing machine (M) according to any of claims 3 to 5, comprising a lid (5) shaped to cover the window (2) to block the entry of light into the chamber (3) from the environment outside the testing machine.

7. Testing machine (M) according to any of the preceding claims 2 to 6, wherein the shuttle (4) comprises a support (7) projecting towards the motorized membrane holder support (12), such support having a top portion defining a support edge of the seat (7a) for atest tray.

8. Testing machine (M) according to claim 7, wherein the support (7) comprises a plurality of fins arranged transversely to the direction of movement of the shuttle (4), and such fins being furthermore longitudinally spaced from each other, each being arranged in use in a position interposed between longitudinally consecutive recesses, each defining an element contrasting the relative longitudinal movement of the tray with respect to the shuttle (4).

Images