FACILITY AND METHOD FOR VALIDATING THE ORIGIN AND/OR QUALITY OF BIOLOGICAL SPECIMEN SECTIONS

20210035663 ยท 2021-02-04

    Inventors

    Cpc classification

    International classification

    Abstract

    The facility for validating the origin and/or quality of biological specimen sections, stored on specimen slides, includes a device for reading encoded identification data, a device for acquiring biometric data specific to a biological specimen, and a data transmitter to a computer processor. The facility validates the origin and/or the quality of biological specimen slides or validates the quality of the staining of biological specimen slides. There are methods for implementing the facility in the context of such uses.

    Claims

    1. A facility for validating the origin and/or quality of biological specimen sections, stored on specimen slides bearing encoded identification data and taken from paraffin blocks also bearing encoded identification data, said facility comprising at least one device for reading encoded identification data, characterized in that it further comprises: at least one device for acquiring biometric data specific to a biological specimen in a paraffin block or specific to a biological specimen stored on a specimen slide in the form of a section taken from a paraffin block, means for transmitting read identification data and acquired biometric data to computer processing means incorporating a software application executed in order to record, in an associated manner in memory means, the identification data read on a paraffin block and the biometric data specific to the biological specimen included in said paraffin block and previously acquired, record the identification data read on a specimen slide and compare them with those recorded for said paraffin block, and, if applicable record the biometric data specific to the biological specimen stored in section form on said specimen slide and compare them with the biometric data recorded in an associated manner with said identification data of said paraffin block, and activate means for genesis of a signal representative of the result of the comparison(s).

    2. The facility according to claim 1, further comprising: an apparatus having a housing configured to receive at least one paraffin block or at least one specimen slide and in which are appropriately installed at least one device for reading encoded data intended to read the identification data of a paraffin block, at least one second device for reading encoded data intended to read the identification device of a specimen slide, as well as at least one device for acquiring biometric data intended to acquire the biometric data specific to a biological specimen included in a paraffin block and/or the biometric data specific to a biological specimen stored in section form on a specimen slide.

    3. The facility according to claim 2, wherein said apparatus comprises a device for acquiring biometric data intended to acquire the biometric data specific to a biological specimen in a paraffin block and a device for acquiring biometric data intended to acquire the biometric data specific to a biological specimen stored in section form on a specimen slide.

    4. The facility according to claim 2, further comprising: a computer provided with computer processing means and at least one user interface, connected to said apparatus by a wired or wireless connection.

    5. The facility according to claim 2, wherein said apparatus incorporates the computer processing means and at least one user interface.

    6. The facility according to claim 1, wherein the device(s) for acquiring biometric data is/are defined by a device for acquiring data relative to a two-dimensional or three-dimensional shape specific to a biological specimen included in a paraffin block or specific to a biological specimen stored on a specimen slide in the form of a section taken from a paraffin block.

    7. The facility according to claim 1, further comprising: at least one bar code reader.

    8. The facility according to claim 4, wherein the user interface of comprises a screen.

    9. A method for validating the origin and/or quantity of biological specimen sections, taken from paraffin blocks provided with encoded identification data, said sections being stored on specimen slides also provided with encoded identification data, the method comprising the steps of: using a facility according to claim 1, reading the identification data of at least one paraffin block using a device for reading encoded data, acquiring the biometric data specific to the biological specimen included in this same paraffin block using a device for acquiring biometric data, recording, in an associated manner, the identification data of the paraffin block and the biometric data specific to the biological specimen included in this same paraffin block in memory means, reading the identification data of at least one specimen slide using a device for reading encoded data, acquiring the biometric data specific to the biological specimen stored in section form in said specimen slide using a device for acquiring biometric data, comparing the identification device of said specimen slide and the identification data of said paraffin block, then comparing the biometric data specific to the biological specimen stored in section form in said specimen slide and the biometric data specific to the biological specimen included in said paraffin block, receiving a signal representative of the result of the comparisons done, and, depending on the case Confirming the origin and/or the quality of the specimen slide, or Invalidating the origin and/or the quality of the specimen slide.

    10. A method for validating the quality of the staining of a specimen slide, the method comprising the steps of: using a facility according to claim 1, reading the identification data of at least one specimen slide, called reference specimen slide, using a device for reading encoded data, acquiring the biometric data specific to the biological specimen stored in suitably stained section form in the reference specimen slide using a device for acquiring biometric data, recording, in an associated manner, the identification data of the reference specimen slide and the biometric data specific to the biological specimen stored in suitably stained section form in the reference specimen slide, in memory means, reading the identification data of a specimen slide using a device for reading encoded data, acquiring the biometric data specific to the biological specimen stored in stained section form in said specimen slide using a device for acquiring biometric data, receiving a signal representative of the result of a comparison between the biometric data specific to the biological specimen stored in stained section form in said specimen slide and the biometric data specific to the biological specimen stored in suitably stained section form in said reference specimen slide, done using computer processing means, and, depending on the case Confirming the quality of the staining of the biological specimen stored in stained section form in the specimen slide and keeping the specimen slide as is, or Invalidating the quality of the staining of the biological specimen stored in stained section form in the specimen slide and subjecting the specimen slide to a new staining step, or destroying the specimen slide.

    11. A use of the facility according to claim 1, so as to validate the origin and/or the quality of biological specimen sections, taken from paraffin blocks and stored on specimen slides or to validate the staining of biological specimen sections stored on specimen slides.

    Description

    BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

    [0056] The present invention will be better understood upon reading the description done in reference to the appended figures, provided as non-limiting examples.

    [0057] FIG. 1 shows a perspective view of a paraffin block incorporating a biological specimen.

    [0058] FIG. 2 is a schematic view of a specimen slide on which a section is stored taken from the paraffin block of FIG. 1.

    [0059] FIG. 3 is a schematic view of a variant embodiment of the facility according to the invention during a step of the method for validating the origin and/or the quality of a biological specimen section taken from the paraffin block of FIG. 1 and stored on the specimen slide of FIG. 2.

    DETAILED DESCRIPTION OF THE INVENTION

    [0060] In reference to the figures, the present invention relates to a facility 1 for validating the origin and/or quality of biological specimen sections 2 stored on specimen slides 3, and taken from paraffin blocks 4.

    [0061] Conventionally, identification data, representative of the patient in question, are assigned once they are taken from all of the biological specimens intended to perform the analyses and/or establish diagnoses, and will stay with them throughout their entire journey through the various departments that may be involved, irrespective of the type of medium on which they are stored.

    [0062] Thus, each paraffin block 4 is provided with such identification data, generally affixed on one face 60 of a cassette 6 containing it, said data for example assuming the form of a matrix code 5, and making it possible to link each paraffin block 4 to the patient from whom the biological specimen 7 that it incorporates originates. Of course, all of the paraffin blocks 4, each incorporating a fraction of an organ coming from a single and same patient, are meant to bear a single matrix code 5.

    [0063] Likewise, each specimen slide 3 on which a sampled section 2 is stored on a paraffin block 4 bears unique identification data, for example in the form of a matrix code 8. Thus, in order to guarantee that a diagnosis is sent to the patient from whom the sample originates, the matrix code 8 of a specimen slide 3 made from a paraffin block 4 must necessarily correspond to the matrix code 5 affixed on the latter.

    [0064] The implementation of the facility 1 according to the invention during the manufacture of specimen slides 3 makes it possible to avoid or detect any affixing of an incorrect matrix code 8 on the latter.

    [0065] In other words, the implementation of the facility 1 immediately after the production of specimen slides 3 makes it possible only to provide pathologists responsible for analyses with specimen slides 3 for which the identity of the patient has been validated beforehand.

    [0066] To that end, in the variant embodiment illustrated in FIG. 3, the facility comprises an apparatus 10 having a housing 11 configured to receive at least one paraffin block 4 or at least one specimen slide 3 and in which have been appropriately installed a first barcode reader 9 intended to read the matrix code 5 affixed on one face 60 of a cassette 6 containing a paraffin block 4, and a second barcode reader 12 intended to read the matrix code 8 of a specimen slide 3. Such an apparatus can be defined by a device for acquiring and analyzing images at the appropriate resolution.

    [0067] Furthermore, the apparatus 10 further incorporates at least one device (not illustrated) for acquiring data relative to a two-dimensional or three-dimensional shape specific to a biological specimen 7 included in a paraffin block 4 or specific to a biological specimen 7 stored, in the form of a section 2 taken from a paraffin block 4 on a specimen slide 3.

    [0068] In short, the apparatus 1 is equipped with means allowing it to read a barcode affixed on a paraffin block 4, means allowing it to read a barcode affixed on a specimen slide 3, means allowing it to determine a characteristic shape of a biological specimen 7 stored in a paraffin block 4, and means allowing it to determine a characteristic shape of a biological specimen 7 stored on a specimen slide 3, in section 2 form taken from this same block 4.

    [0069] The facility 1 also comprises a computer 14, provided with a screen 15 and a keyboard 16, and connected to the apparatus 1 by data transmission means 13, which may be wired or wireless.

    [0070] According to the invention, the computer 14 incorporates computer processing means incorporating a software application executed in order, in the described embodiment, to:

    [0071] record, in an associated manner in memory means, the identification data read from the matrix code 5 on a paraffin block 4 and the data relative to the characteristic shape of the biological specimen 7 included in this same paraffin block 4,

    [0072] record the identification data read from the matrix code 8 on a specimen slide 3 and compare them with those recorded for said paraffin block 4, and, if applicable

    [0073] record the data relative to the characteristic shape of the biological specimen 7 stored in section 2 form on said specimen slide 3 and compare them with the data relative to the characteristic shape of the biological specimen 7 included in the paraffin block 4 recorded in an associated manner with the identification data of said paraffin block 4, and

    [0074] activate means for genesis of a signal representative of the result of the comparison(s), for example in the form of a visual signal appearing on the screen 15 of the computer 14.

    [0075] In practice, the facility according to the invention can be used in the context of the application described above to automatically validate the origin of a biological specimen 7 stored in section 2 form on a specimen slide 3.

    [0076] This validation is advantageously done on two levels, namely through a comparison between the identification data affixed on the specimen slide 3 and those affixed on the paraffin block 4 used to produce it, and a second comparison done this time between the shape of the specimen 7 supported by the slide 3 and that of the specimen 7 included in the paraffin block 4. Comparing the shapes advantageously also makes it possible to detect any section defects (such as tissue folds or slide marks, etc.), and in particular sections done at insufficient depths in the paraffin block and which may lead to incorrect diagnoses.

    [0077] In this context, the implementation of the facility 1 consists of first placing a paraffin block 4 in the housing 11 of the apparatus 10 of the facility 1, then reading the matrix code 5 of a paraffin block 4 using a barcode reader 9 and next determining a shape specific to the biological specimen 7 included in this same paraffin block 4 using a device for acquiring and analyzing an image at the appropriate resolution (not illustrated).

    [0078] The read identification data of the paraffin block 4 and the data relative to the shape specific to the biological specimen 7 included in this same paraffin block 4 are then automatically recorded in an associated manner in the memory means of the computer 14.

    [0079] Then, the paraffin block 4 is removed from the housing 11 of the apparatus 10, and replaced by a specimen slide 3 produced from said paraffin block 4, and the origin and quality of which must be validated. To that end, it is then necessary to read the identification data of the specimen slide 3, using the barcode reader 12, then to determine a shape specific to the biological specimen 7 stored in section form 2 in said specimen slide 3 using said image acquisition and analysis device.

    [0080] The computer processing means of the computer 14 then generate a signal representative of the result of a comparison between the matrix code 8 of said specimen slide 3 and the matrix code 5 of said paraffin block 4 and, if applicable, a comparison between the shape specific to the biological specimen 7 stored in section form 2 in said specimen slide 3 and the shape specific to the biological specimen 7 included in said paraffin block 4, done by computer processing means. This signal is displayed on the screen 15 and, depending on the case, will correspond to a confirmation of the origin and/or of the quality of the specimen slide 3, or to an invalidation of the origin and/or the quality of the specimen slide 3.

    [0081] If an insufficient match is detected between the shape of the specimen 7 present on the specimen slide 3 and that of the specimen 7 included in the paraffin block 5, or if a section 2 done at an insufficient depth is detected, the operator having produced the specimen slide 3 will be notified immediately, as of the end of this production. This will allow him to detect any error in assigning a slide 3 to an incorrect patient or to observe any production defect requiring new additional sections.

    [0082] A comparison of the shapes can also make it possible to detect any tissue folds or microtome slide marks present in a biological specimen stored in a section 2 on a specimen slide 3, and which may also lead to diagnostic errors. The specimen slides 3 bearing such sections 2 will thus also be able to be removed during the validation done using the facility 1, without being sent to the pathologist responsible for analyzing them.

    [0083] It is also possible to provide for the destruction of any specimen slide 3 once an error of any kind is detected, so as to avoid any future diagnostic error or assignment of the latter to an incorrect recipient.

    [0084] Furthermore, the facility 1 could also be implemented solely to verify the quality of the staining of a section 2 stored on a specimen slide 3. In this case, it is provided to use a so-called reference specimen slide for which it is established that all of the elements that may be observed on the specimen 7 have indeed been revealed following the performed chemical treatments.

    [0085] In the context of this application, it is in practice provided to first position, in the housing 11 of the apparatus 10, a reference specimen slide in order to acquire the shape specific to a biological specimen 7 stored in suitably stained section 2 form in this same reference specimen slide, using the image acquisition and analysis device, after having read the matrix code of said reference slide. The obtained image is then recorded in the memory means of the computer 14, associated with the identification data of the reference specimen slide. Then the reference specimen slide is removed from the housing 11 and replaced by the specimen slide 3 for which one wishes to verify the staining quality. The barcode reader 12 is activated again, then the image acquisition and analysis device is addressed, this time to determine the shape specific to the biological specimen 7 stored in stained section 2 form in the specimen slide 3.

    [0086] A signal is then displayed on the screen 15 of the computer 14. It is representative of the result of a comparison between the shape specific to the biological specimen 7 stored in stained section 2 form in the specimen slide 3 and the shape specific to the biological specimen 7 stored in suitably stained section 2 form in the reference specimen slide, done by the computer processing means of the computer 14. This signal clearly informs the operator of the actions to be performed, namely, depending on the case

    [0087] to keep the specimen slide 3 as is, when the staining proves to be satisfactory, or

    [0088] to subject the specimen slide 3 to a new staining step with a refreshed solution, or

    [0089] to destroy the specimen slide 3 when it proves to be irrecoverable.