DEVICE AND PROCESS FOR SCREENING OF A BIOLOGICAL SAMPLE
20220214270 · 2022-07-07
Inventors
Cpc classification
G01N21/314
PHYSICS
G01N35/02
PHYSICS
G01N2035/047
PHYSICS
G01N35/00732
PHYSICS
International classification
G01N21/31
PHYSICS
G01N21/25
PHYSICS
Abstract
A device for screening of a biological sample in a container includes a lighting system having a radiation source, an analysis station having an optical detector and controller. The lighting system includes a filter holder device for selecting two radiations with different wavelengths. The analysis station includes a system for optical detection of the container before analysis of the sample, which includes a backlight panel and an illuminator for illuminating the container and to allow the optical detector to acquire an image of the container and send to the controller information based on the image. The controller controls a rotation system, set up in the analysis station, to position the container so that, in the analysis phase of the sample, the radiation irradiates the sample at an inspection window and a label is arranged on an opposite side with respect to that from which the radiation originates.
Claims
1. A device for screening of a biological sample contained in a container which is housed by a transport device and which has at least one label attached to a surface thereof, said device comprising: a lighting system comprising a radiation source, an analysis station in which said container is irradiated by a radiation emitted by said radiation source, and comprising an optical detector for collecting said radiation after it has irradiated the container, an optical fiber connected at a first end with said lighting system and at a second end with said analysis station, for conveying the radiation emitted by said radiation source towards said container in said analysis station, an automated transport line comprising an automatic conveyor configured to move forward said transport device housing said container through said analysis station, and an electronic controller, configured to process signals emitted by said optical detector, wherein said lighting system comprises a filter holder device located downstream of said radiation source, comprising at least two filters for selecting at least two radiations with different wavelengths, including a reference radiation and an absorption radiation, wherein said optical detector is a camera or video camera, configured to collect radiation reflected by a volume of the sample in the container and by said at least one label attached to the container, when the at least one label is on a side of the container opposite to that from which the radiation emitted by said radiation source originates, said camera or video camera being provided with at least a first sensor sensitive to said reference radiation and with at least a second sensor sensitive to said absorption radiation, said first sensor and said second sensor being configured to detect, respectively, intensity values of components of said reference radiation and of said absorption radiation which are not absorbed by said biological sample and to send said intensity values to said electronic controller, said electronic controller being configured and programmed to process a ratio between the intensity value of the components of absorption radiation not absorbed by said biological sample and the intensity value of the components of reference radiation not absorbed by said biological sample, in any order, wherein said analysis station further comprises an optical detection system of the container for analysis of the biological sample contained therein, wherein said optical detection system of the container includes a backlight panel and a front illuminator placed one in front of the other and configured to illuminate said container, and to allow said camera or video camera (30) to acquire, at least one image of said container, and to send to said electronic controller information based on said at least one acquired image, said analysis station comprising a rotation system for rotating said container around a vertical axis of its own, said electronic controller being configured and programmed to control said rotation system on a basis of information received from said camera or video camera to position said container so that, during a following analysis phase of the biological sample contained in the container: a) said at least one label attached to a surface of said container is arranged on the opposite side with respect to that from which the radiation emitted by the optical fiber originates, and b) the radiation emitted by said optical fiber irradiates said volume of the sample at a predetermined inspection window.
2. The device according to claim 1, wherein said filter holder device comprises at least two filters for selecting respectively an absorption radiation with a wavelength of 450 nm and a reference radiation with a wavelength of 660 nm, in order to detect a presence of lipemia in said biological sample.
3. The device according to claim 1, wherein said filter holder device comprises at least two filters for selecting respectively an absorption radiation with a wavelength of 575 nm and a reference radiation with a wavelength of 660 nm, in order to detect a presence of hemolysis in said biological sample.
4. The device according to claim 3, wherein said filter holder device comprises at least one further filter for selecting an absorption radiation with a wavelength of 520 nm, in order to detect a presence of icterus in said biological sample.
5. The device according to claim 4, wherein said filter holder device comprises at least one additional filter for selecting an absorption radiation with a wavelength of 450 nm, in order to detect a presence of hemolysis, icterus and lipemia in said biological sample by performing a single analysis.
6. The device according to claim 5, wherein said filter holder device comprises at least one black filter, in order to perform a quality control on the radiation emitted by said radiation source.
7. The device according to claim 1, wherein said filter holder device is a filter holder wheel.
8. The device according to claim 1, wherein said backlight panel and said radiation source are light-emitting diodes (LEDs).
9. The device according to claim 1, wherein said automated transport line is configured to transport said transport device housing said container downstream of said analysis station up to an analyzer.
10. The device according to claim 9, wherein said automated transport line comprises a station located downstream of said analysis station and upstream of said analyzer, said station being configured to remove containers marked as unacceptable following the analysis carried out in said analysis station.
11. A process for screening of a biological sample contained in a container which is housed by a transport device and which has at least one label attached to a surface thereof, said process comprising the steps of: providing an automated transport line comprising an automatic conveyor configured to move forward said transport device housing said container through an analysis station, irradiating said container n said analysis station with a radiation emitted by a radiation source and collecting through an optical detector said radiation after it has irradiated the container, providing an electronic controller to process signals emitted by said optical detector to perform the screening of the biological sample contained in the container, selecting at least two radiations with different wavelengths, including a reference radiation and an absorption radiation, filtering the radiation emitted by said radiation source by means of at least two filters carried by a filter holder device located downstream of said radiation source, by means of said optical detector of the analysis station in the form of a camera or video camera, collect radiation reflected by a volume of the sample in the container and by said at least one label attached to the container, when the at least one label is on a side of the container opposite to that from which the radiation emitted by said radiation source originates, detect and send to said electronic controller intensity values of components of said reference radiation and of said absorption radiation which have not been absorbed by said biological sample, respectively by means of a first sensor and a second sensor included in said camera or video camera, process by means of said electronic controller a ratio between the intensity value of the components of absorption radiation not absorbed by said biological sample and the intensity value of the components of reference radiation not absorbed by said biological sample, in any order, preliminarily to an analysis of the biological sample contained in the container, perform an optical detection of the container, making use of a backlight panel and a front illuminator placed one in front of the other and configured to illuminate said container, in order to allow said camera or video camera to acquire at least one image of said container, and send to said electronic controller information on the basis of said at least one acquired image, rotate said container around a vertical axis, on a basis of the information received from said camera or video camera to position said container so that, during an analysis phase of the biological sample contained in the container: a) said at least one label attached to the surface of said container is arranged on the opposite side with respect to that from which the radiation directed towards the container originates, and b) the emitted radiation irradiates said volume of the sample at a predetermined inspection window.
12. The process according to claim 11. wherein said filter holder device comprises at least two filters for selecting respectively an absorption radiation with a wavelength of 450 nm and a reference radiation with a wavelength of 660 nm, in order to detect a presence of lipemia in said biological sample.
13. The process according to claim 11, wherein said filter holder device comprises at least two filters for selecting respectively an absorption radiation with a wavelength of 575 nm and a reference radiation with a wavelength of 660 nm, in order to detect a presence of hemolysis in said biological sample.
14. The process according to claim 13, wherein said filter holder device comprises at least one further filter for selecting an absorption radiation with a wavelength of 520 nm, in order to detect a presence of icterus in said biological sample.
15. The process according to claim 14, wherein said filter holder device comprises at least one additional filter for selecting an absorption radiation with a wavelength of 450 nm, in order to detect a presence of hemolysis, icterus and lipemia in said biological sample by performing a single analysis.
16. The process according to claim 15, wherein said filter holder device comprises at least one further black filter, in order to perform a quality control on the radiation emitted by said radiation source.
17. The process according to claim 11, wherein said automated transport line is configured to transport said transport device housing said container downstream of said analysis station up to an analyzer.
18. The process according to claim 17, wherein containers marked as unacceptable following the analysis carried out in said analysis station are removed from a station located downstream of said analysis station and upstream of said analyzer, said station being included in said automated transport line.
Description
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0041] Further features and advantages of the invention will become apparent from the following description with reference to the annexed drawings, given purely by way of non-limiting example, in which:
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[0057] In
[0058] In the preferred embodiment, the automated transport line 2 is able to transport the container 6 downstream of the analysis station, up to an analyzer (not shown).
[0059] With reference in particular to
[0060] In the preferred embodiment the container 6 of biological sample is a test tube. However, this feature is not to be intended in a limiting sense, since the container 6 can be any known container of a biological sample, for example a cuvette or a centrifuge tube.
[0061] As visible in
[0062] As visible in
[0063] The lighting system 4 and the analysis station 3 are connected by means of an optical fiber 53, having a first end connected with the lighting system 4 and a second end connected with the analysis station 3. In the preferred embodiment, the outlet of the optical fiber 53 in the analysis station 3 is located above the group consisting of the camera 30 and the lens 31 (
[0064] As shown in
[0065] As can be seen in particular in
[0066] As shown in
[0067] As can be seen in
[0068] As can be seen in
[0069] The invention also relates to a process for the screening of a biological sample contained in a container 6 which is housed by a transport device 20 and which has at least one label 600 attached to a surface thereof, comprising the steps of: [0070] providing an automated transport line 2 comprising an automatic conveyor 5 able to move forward the transport device 20 housing the container 6 through an analysis station 3, [0071] irradiating the container 6 in the analysis station 3 with a radiation emitted by a radiation source 50 and collecting through an optical detector the radiation after it has irradiated the container 6, [0072] providing an electronic controller E to process signals emitted by the optical detector to perform the screening of the biological sample contained in the container 6, [0073] filtering the radiation emitted by the radiation source 50 selecting a filter between at least two filters carried by a filter holder device located downstream of the radiation source 50, [0074] collecting the radiation reflected by a volume 60 of the sample in the container 6 and by the label 600 attached to the container 6 by means of the optical detector 30, in the form of a camera or video camera, when the label 600 is on the side of the container 6 opposite to that from which the radiation emitted by the optical fiber 53 originates, [0075] preliminarily to the analysis of the biological sample contained in the container 6 performing an optical detection of the container 6, making use of a backlight panel 33 and a front illuminator 32 placed one in front of the other and able to illuminate the container 6, and in order to allow the camera or video camera 30 to acquire, and possibly store, at least one image of the container 6, and to send to the electronic controller E an information on the basis of the acquired image, [0076] rotating the container 6 around a vertical axis, on the basis of the information received from the camera or video camera 30 to position the container 6 so that: [0077] a) the label 600 attached to the surface of the container 6 is arranged on the opposite side with respect to that from which the radiation directed towards the container 6 originates, [0078] b) the emitted radiation irradiates the volume 60 of the sample at a predetermined inspection window 61.
[0079] It is to be understood that the aforementioned process can be carried out using any of the embodiments of the device 1 described above.
[0080] In the preferred embodiment, the process comprises the further step of detecting, by means of a first and a second sensor included in the camera or video camera 30, the intensity values of the components of reference radiation and absorption radiation which have not been absorbed by the biological sample, and of sending them to the electronic controller E. Preferably, the electronic controller E processes a ratio between the intensity value of absorption radiation not absorbed by the biological sample and the intensity value of reference radiation not absorbed by the biological sample, in any order.
[0081] In the preferred embodiment, the process comprises the further step of transporting, by means of the automated transport line 2, the container 6 housed by the transport device 20 downstream of the analysis station 3 up to an analyzer (not shown). Preferably, the containers 6 marked as unacceptable following the analysis carried out in the analysis station 3 are removed from a station (not shown) located downstream of the analysis station 3 and upstream of the analyzer.
[0082] In the following, a description will be given regarding the use of the preferred embodiment of the device 1 for the determination of serum indices of a biological sample and, more specifically, of the presence of hemolysis, icterus and lipemia (hereinafter: “HIL”) in that sample. However, this implementation is not to be intended in a limiting sense, since the device 1 can also be used for other types of analyses and determinations to be carried out on biological samples, which provide for the irradiation of the sample with a light radiation and the following detection of the intensity of radiation not absorbed by the sample.
[0083] In the use of the embodiment shown in
[0084] Since the analysis is carried out by selecting in sequence 4 different wavelengths (450 nm, 520 nm, 575 nm and 660 nm) from the radiation emitted by the image source 50 by means of the filter holder wheel 51, the camera 30 acquires a series of images related to these wavelengths. The camera 30 is color, i.e. it is equipped with sensors, each of which sensitive to an area of the visible spectrum corresponding to the four wavelengths used. Each lighting corresponds to a specific color signal. More specifically, 450 nm correspond to a blue signal, 520 nm to a green signal, 570 nm to a yellowish signal and 660 nm to a red signal. In this way it is possible to distinguish the response of the camera 30 on each of the color channels. The camera 30 provides a result, for each of the acquired images, expressed in terms of grey levels of the image, from “255” (very intense signal tending to white) up to “0” (dark signal, tending to black). A grey level response is therefore obtained for each of the above mentioned colored channels; each grey level is given by the sum of the two signal components 300a, reflected by the sample volume 60, and 300b, reflected by the label 600. The ratio between the grey level values, corresponding to the respective light intensities, for two of the wavelengths of interest, gives a non-dimensional number, shown in ordinate in the graph represented in
[0085] In
[0086] As can be seen, there are few cases in which the samples have been underestimated (“false negatives”, quarter II), that is samples classified by the device 1 as “little” hemolytic that have a high real H value, and there are just as few cases in which they have been overestimated (“false positives”, quarter IV), that is samples classified by the device 1 as “very” hemolytic which have a low real H value. The measurements in quarters I and III (as can be seen, definitely the majority) are instead the correct ones, in which the sample detected by the device as “hemolytic” (quarter III) or “non-hemolytic” (quarter I) is actually such. This also depends, of course, on thresholds that are established to distinguish a sample as “little hemolytic”, “hemolytic” and “very hemolytic”. These thresholds can be arbitrary and vary for each laboratory. In this way there is also the possibility of discriminating the samples by “classes”, dividing them according to different intervals to establish their level of H, on the basis of the same division at intervals that often also the analyzers apply. By analyzing the grey dashes of the graph represented in
[0087] The scope is substantially identical for the use of device 1 in an analysis of different serum indices of the biological sample, for example an analysis of icterus levels (
[0088] The samples that are identified as unacceptable following the screening performed in the analysis station 3 are removed from the automated transport line 2 by means of a system arranged for this purpose (not shown), located downstream of the analysis station 3 and upstream of the analyzer, in order to prevent the performance of analyses on samples determined as unsuitable.
[0089] As it is clear from the above description, the device according to the invention is characterized by greater accuracy and precision of analysis than the currently known devices for the performance of the screening of a biological sample. The positioning of the biological sample container, prior to the screening, in order to exploit the label attached on its surface to reflect the radiation component not absorbed by the sample towards the camera or video camera, advantageously placed on the same side of the analysis source with respect to the container, allows to limit the error that arises when working in transmission and the radiation must pass through the label before being detected by the camera.
[0090] Studies and experiences carried out by the Applicant have shown that the use of a filter holder device that enables to select multiple different filters and, consequently, as many wavelengths during the same analysis allows to perform, in a single screening, the detection of several different parameters, significantly speeding up the procedures compared to the currently known devices.
[0091] Of course, without prejudice to the principle of the invention, the construction details and the embodiments may vary widely with respect to what is described and illustrated purely by way of example, without thereby departing from the scope of protection of the present invention, as defined in the annexed claims.