EP4330675A1 - Kit de criblage in vitro côté patient pour le diagnostic rapide d'une pathologie - Google Patents

Kit de criblage in vitro côté patient pour le diagnostic rapide d'une pathologie

Info

Publication number
EP4330675A1
EP4330675A1 EP22725534.6A EP22725534A EP4330675A1 EP 4330675 A1 EP4330675 A1 EP 4330675A1 EP 22725534 A EP22725534 A EP 22725534A EP 4330675 A1 EP4330675 A1 EP 4330675A1
Authority
EP
European Patent Office
Prior art keywords
recesses
support
kit according
kit
antibody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22725534.6A
Other languages
German (de)
English (en)
Inventor
Alfredo De Rosa
Marina DI DOMENICO
Riccardo MOFFA
Mariarosaria BOCCELLINO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Stark Sarl
Original Assignee
Stark Sarl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stark Sarl filed Critical Stark Sarl
Publication of EP4330675A1 publication Critical patent/EP4330675A1/fr
Pending legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57407—Specifically defined cancers
    • G01N33/5743—Specifically defined cancers of skin, e.g. melanoma
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/52—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • B01L9/523—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips for multisample carriers, e.g. used for microtitration plates
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • the present invention is in the field of the rapid diagnosis of a pathology, e.g. of a cancer pathology such as melanoma using a kit, stable at room temperature.
  • the invention refers to a method that can also be performed in environments outside the laboratory, "patient side" with immediate response of a chemocolorimetric, bioluminescent or digital reader for the diagnosis and/or prediction of the risk of developing melanoma comprising the detection in cell extracts of certain cancer markers using immunoassays, such as ELISA (enzyme linked immunosorbent assay).
  • Melanoma is a cancer that affects the skin, among all types of skin cancers, it is the least common but also the most dangerous because it can grow quickly and also invade the surrounding tissues. It is a naked eye visible cancer and it originates from a pre-existing naevus that changes shape or colour or from the appearance of a new naevus on intact skin. It is always a malignant neoplasm, in fact it is never possible to define a benign melanoma, at most we can speak of a benign naevus that does not have the characteristics of a melanoma.
  • Cutaneous melanomas originate both on intact skin and from pre-existing naevi, which are present from birth or early childhood (congenital) or appear during the course of life (acquired). Cutaneous melanoma accounts for 9% of juvenile cancers in men and 7% in women; it is quite rare in children and mainly affects around 45-50 years of age, although the average age at diagnosis has dropped in recent decades. In Italy there are an estimated 7,300 new cases each year among men and 6,700 among women, the incidence is constantly growing and has even doubled in the last 10 years.
  • a useful and easy to remember method for recognizing a suspicious naevus is the abbreviation ABCD which lists its characteristics: A as an asymmetry of the shape, B as irregular edges, C as a variable colour, D as an increasing size both in width and in thickness.
  • ABCD A useful and easy to remember method for recognizing a suspicious naevus
  • a useful and easy to remember method for recognizing a suspicious naevus is the abbreviation ABCD which lists its characteristics: A as an asymmetry of the shape, B as irregular edges, C as a variable colour, D as an increasing size both in width and in thickness.
  • congenital naevi are rounded, have a uniform colour and do not undergo changes over time.
  • Primary melanoma refers to the first appearance of melanoma and can usually be seen on the skin surface. Melanoma can quickly spread to any part of the body, so it's important to spot and treat it in its early stage. When melanoma is identified in its early stages, there is a very good chance that all of the cancer can be surgically removed before it spreads to other parts of the body and in that case the chances of long-term survival are excellent. Rapid screening therefore becomes of primary importance to direct the doctor towards the treatment plan. There are currently no scientifically reliable, non-invasive screening methods for the prevention of melanoma.
  • the present invention refers to an innovative kit with ELISA technique and chemocolorimetric, bioluminescent or digital result for the early diagnosis of a pathology, preferably of a cancer pathology such as a melanoma.
  • the kit uses reagents that are stable at room temperature, is rapid, sensitive, specific, transportable, cheap and non-invasive.
  • the kit of the invention allows the determination of a specific antigen associated with a pathology of interest, in the case of cancer pathologies such as melanoma, PRAME (PReferentially expressed Antigen Melanoma) by means of a double use of primary antibodies to ensure unequivocal the specificity and sensitivity of the signal.
  • a first polyclonal primary antibody e.g.
  • rabbit anti-PRAME will be adhered to a PVDF membrane, a second primary monoclonal antibody e.g. of mouse anti- PRAME will be used in test tube. Subsequently, secondary anti-mouse antibodies conjugated with an enzymatic signal amplification system, in particular alkaline phosphatase or peroxidase, will be used.
  • an enzymatic signal amplification system in particular alkaline phosphatase or peroxidase
  • the kit comprises at least one substrate such as ABTS (2,2'-Azinobis [3-ethylbenzothiazoline- 6-sulfonic acid] -diammonium salt), OPD (o-phenylenediamine dihydrochloride), TMB (3 , 3 ', 5,5'-tetramethylbenzidine), p-Nitrophenyl Phosphate (PNPP).
  • substrate such as ABTS (2,2'-Azinobis [3-ethylbenzothiazoline- 6-sulfonic acid] -diammonium salt
  • OPD o-phenylenediamine dihydrochloride
  • TMB 3 , 3 ', 5,5'-tetramethylbenzidine
  • PNPP p-Nitrophenyl Phosphate
  • the kit uses dried or lyophilized antibodies, stable at room temperature, which at the time of use are solubilized in a buffer solution present in the kit.
  • the present invention is configured as an effective diagnostic aid for a pathology e.g. a cancer pathology such as melanoma, which does not require laboratory aids and provides immediate answers.
  • a pathology e.g. a cancer pathology such as melanoma
  • the invention also refers to the creation of an innovative kit built by assembling commercially available and custom made semi-finished products.
  • the kit comprises a hard bristle cytobrush useful for taking the biological sample e.g. at the level of the epidermis and the necessary to allow the professional (Doctor or person entitled to use by the regulations in force in the area of use) to analyse it and verify the presence of the biomarker e.g. of the cancer biomarker or to process it through a specific automatic development device.
  • the product has an extremely simple method of use.
  • kit equipped with a cytobrush or other known device eg. stick intended for the collection of biological material and, strip or strips of PVDF (pol vinylidene fluoride) suitably mounted on a rigid support and preloaded test tubes of powders of protease inhibitors in the dried state, lyophilized and/or dried antibodies, tubes preloaded with liquids, liquids for washing, developing and detecting the enzymatic signal and devices for the solubilization of preloaded reagents, in particular two-phase break-out capsules.
  • a sterile medical patch can be used, e.g. comprising an adhesive support in non-woven fabric.
  • gauze preferably also of non- woven fabric, combined with a substance with antibacterial activity, e.g. 0.5% chlorhexidine digluconate.
  • Kit operation diagram dissolve the reagents present in the wells/station P in the dried and or lyophilized state upon opening the kit by perforating the overlying re ervoirs S having function as break-out cap (figure above). Collection of potentially malignant cells from the dermis with the specific tools to carry out the collection; immersion of the same in the well/station zero, containing a protease inhibitor and a buffer lysing the cells collected by means of the collection device.
  • Transfer of the lysate from the well/station zero to the well/station one preferably empty when the user opens the kit; immersion of the PVDF strip in the well/station one for the recognition of the cancer antigen by the specific primary antibodies immobilized on the PVDF strip.
  • the formation of immunecomplexes takes place on the strip if there is the presence of the cancer protein in the sample collected.
  • the PVDF strip with the immobilized immunecomplexes is immersed into well/station number two containing a primary target solution equally specific for the antigen e.g. cancer, but of a different species from those adsorbed on the membrane.
  • the use of the second on the series of primary antibodies has the purpose of allowing a specific recognition by the secondary antibody used in the next phase, preventing the latter from binding to all the useful primary adsorbed on the PVDF strip. Washings with T-PBS will take place in wells/stations number three and four.
  • the wells and/or reservoirs are preferably produced based on aromatic hydrocarbons so as to be hydrophobic and allow a total convergence of the quantities of fluid at the bottom of the recesses and, even more preferably, produced as a monolayer for example of polystyrene.
  • each well or recess again in order to favour the convergence towards the bottom of the liquid substances in use, has convex walls observing the inside of the recesses.
  • the support 10 of figure 2 defines recesses 11 for liquid substances and recesses 12 for powdered or dried substances e.g. protease inhibitor/dried antibodies.
  • the kit comprises a support 20 superimposed on the support 10 and having corresponding recesses 21 containing pre-defined quantities i.e. dosed liquids e.g. a lysis buffer and a buffer liquid, to define a two-phase container in use.
  • recesses 12 house recesses 21 when support 20 rests on support 10.
  • Support 20 is preferably produced by thermoforming like support 10 and, even more preferably, support 20 is of the same polymeric material as support 10.
  • peelable layer 13 comprises a gripping appendage 14 e.g. having a smaller transverse dimension but, in any case, such as to close a recess 11.
  • Peelable layer 13 has one or more openings A to surround, when it adheres to support 10, recesses 12 and thus allow recesses 21 to be housed in the latter when support 20 rests on support 10.
  • Support 20 is also closed by means of a corresponding peelable closing layer 22 bearing symbols SI, S2, S3 to identify, each one, a preferred point for breaking layer 22 and underlying recess 21 in order to perform the mixing of the substances.
  • recesses 21 contain a pre-defined quantity of liquid and this helps the complete gravity fall into recess 12 of the liquid: this is particularly important when, as in this case, the metered quantities are of a few micrograms and/or as in this case of 280 picograms.
  • symbols SI, S2, S3 provide a perforation sequence, which is preferably performed by means of a suitable tool 30 ( Figure 3).
  • the tool has a shaped grip, for example triangular, having a dimension such as to contact during the perforation an edge of recesses 21, also having a calibrated geometry and dimension.
  • the tool is in the position of maximum advancement towards the bottom of corresponding recess 12 and also a height between a perforation head of the tool and the abutment position between the shaped grip and the edge of recess 21 is pre-defined in so as to perforate recess 21 in a pre-defined manner and depth independent of the user that performs the operation.
  • Figure 3 further illustrates a stick 40 on which the primary antibodies, e.g. through a membrane facing a window 41, are applied. Through the window 41, the antibodies are exposed to the substances contained in recesses 11, 12 to define any antigens, e.g. cancer antigens.
  • Figure 3 further illustrates an exploded view of the main components of the kit, i.e. supports 10 and 20 and a base 50 preferably with a double basin.
  • Supports 10 and 20 are preferably arranged in pocket 51 so that the recesses 11, 12 are suspended when support 10 abuts against an edge of the pocket.
  • Stick 40, perforation tool 30, the collection tool and a Pasteur pipette are preferably arranged in pocket 52.
  • Base 50 is preferably closed by means of a preferably square-shaped band casing which slides laterally with reference to the point of view of Figure 3.
  • the kit can be adapted e.g. by number of biphasic containers and/or recesses, dehydrated or dried substances and liquids, to test methods made for other diseases.
  • support 20 or in an embodiment not shown support 10, comprises one or more spacer projections D having a calibrated vertical dimension and such as to define the adapted position wherein recesses 21 are housed in the corresponding recesses 12.
  • recesses 21 have a vertical dimension greater than that of the spacer projections D so that an end portion T of recesses 21 is within recesses 12.
  • pocket 52 houses at least one pipette, preferably a Pasteur pipette, in order to transfer the liquid from one recess 11, 12 to the other.
  • pocket 51 has a stepped profile and, correspondingly, support 10 has a lower width LI so as to rest a first step G1 of a width L2 of support 20. The latter abuts on a step G2 arranged above the step G1 when the kit is placed on a table.
  • the method for the early diagnosis and monitoring of melanoma of the present patent provides for the detection of the antigen expressed mainly in human melanomas (PRAME) in samples collected from suspected naevi of the subject under examination.
  • PRAME marker in the context of the present invention also includes variants, isoforms etc. Said marker is characterized by an NCBI Access number and the antibodies used for the preparation of the device preferably refer to the following collected purely by way of example: PRAME Monoclonal Antibody (CL5148) (Product # MA5-31409); PRAME Polyclonal antibody, N-term Cat No. GTX45142; Mouse IgG (Fc fragment) antibody, F (ab') 2 fragment, pre-adsorbed (AP) Cat No. GTX25880 (Goat, Polyclonal) or Goat Anti-Mouse IgG antibody (HRP) Cat No. GTX 213211-01.
  • the steps for preparing the PVDF strip armed with the primary antibodies of interest in sequence are as follows: hydration of the PVDF strip (ThermoFisher Scientific Catalog Number LC2002) with methanol for 5 min; washing with water for 5 min; two washes with PBS for 5 min; incubation with protein A from Staphylococcus aureus (Sigma- Aldrich, 10 pg / mL) for 1 h in PBS; two washes with PBS; blocking with 3% BSA solution in PBS for 1 h; three washes with PBS for 5 min; assembly of the PVDF; incubation with rabbit antibody solution (PRAME Rabbit Polyclonal antibody, N-term Cat No.
  • the Positive Control is an anti-actin antibody (Sigma - Aldrich, A2066).
  • kits equipped with cytobrush for the collection of biological material and support for the PVDF (Immobilon) strip armed with the primary antibodies of interest are described below.
  • the kit box is organized in rows of nine wells/stations containing buffers, lysing systems, detection systems stable at room temperature and dried/lyophilized antibodies stable at room temperature (Fig. 1).
  • EXAMPLE 4 How to use the kit The following are the operational steps which in sequence allow the diagnosis of melanoma or another pathology: collecting the sample from the suspect naevus, using the collection tools within the kit; immersing the biological sample for 15 min in the well/station number zero containing the lysis buffer; extracting the tool and transfering the lysate to the well/station number one; opening the package of the support to which the PVDF membrane is adhered; immersing the support with the PVDF strip for 5 min in the first well/station number one to allow the interaction of the proteins (antigens) with the primary antibodies adhered to the PVDF strip, in order to form the immunocomplex (purely by way of example: PRAME Polyclonal antibody, N-term Cat No.
  • the PVDF membrane is i mersed in well/station number two containing in solution the second primary mouse antibody (purely by way of example: PRAME Monoclonal Antibody (CL5148) (Product # MA5-31409) for the reaction with the immobilized immunocomplex; proceed with 2 washes of the support with the PVDF strip in wells containing T-PBS-buffer to eliminate the non- specifically attached proteins to the immunocomplex; immersion of the support with the PVDF strip for 10 min in well/station number five containing the mouse secondary antibody (purely by way of example: Mouse IgG (Fc fragment) antibody, F (ab') 2 fragment, pre-adsorb and (AP) Cat No.
  • GTX25880 Goat, Polyclonal
  • a detector enzymatic system alkaline phosphatase or peroxidase
  • BCIP / NBT stable at room temperature or Luminol ECL substrate
  • the colorimetric test will be carried out at room temperature, corresponding to a temperature range between 20° and 30° C.
  • the use, in the kit, of a secondary antibody having a detector enzymatic system (alkaline phosphatase or peroxidase) has in this temperature range the maximum enzymatic activity, thus allowing an optimal signal amplification.
  • EXAMPLE 6 Use of the kit of the invention for the identification of an individual with melanoma.
  • the Operator After having highlighted the suspected lesion by means of an epilluminescence examination, places the cytobrush on it and performs the sampling maneuver.
  • the maneuver consists in rotating the cytobrush on itself 4-5 times, exerting constant pressure.
  • This method of cell collection is totally safe and free from any iatrogenic type problem.
  • This technique can also be used to perform mass screening on populations, given that such neoplasm ranks fourth by incidence in the world. Thanks to this protocol it is possible to implement the correct principles for primary prevention.
  • the exam can be performed by qualified personnel after having performed a learning trial on the collection method.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Un procédé in vitro pour identifier un mélanome chez l'homme à l'aide d'un kit qui permet d'effectuer un dosage ELISA côté patient, avec des réactifs séchés ou lyophilisés, qui sont ramenés en solution et/ou mélangés au moment de l'utilisation du kit, fournissant une réponse qualitative et chimiocolorimétrique immédiate, bioluminescente, comprenant les étapes consistant à :a) détecter et/ou quantifier un antigène spécifique, par exemple exprimé principalement dans les mélanomes (FRAME) dans un échantillon biologique obtenu à partir du sujet ; b) comparer le résultat avec un échantillon témoin; par exemple, la présence de FRAME indique que le sujet souffre d'un mélanome.
EP22725534.6A 2021-04-26 2022-04-26 Kit de criblage in vitro côté patient pour le diagnostic rapide d'une pathologie Pending EP4330675A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202100010463 2021-04-26
PCT/IB2022/053874 WO2022229849A1 (fr) 2021-04-26 2022-04-26 Kit de criblage in vitro côté patient pour le diagnostic rapide d'une pathologie

Publications (1)

Publication Number Publication Date
EP4330675A1 true EP4330675A1 (fr) 2024-03-06

Family

ID=77021931

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22725534.6A Pending EP4330675A1 (fr) 2021-04-26 2022-04-26 Kit de criblage in vitro côté patient pour le diagnostic rapide d'une pathologie

Country Status (2)

Country Link
EP (1) EP4330675A1 (fr)
WO (1) WO2022229849A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT5044U1 (de) * 2001-05-10 2002-02-25 Medsystems Diagnostics Gmbh Quantitativer einschritt immuntest in lyophilisierter form
CN102869682B (zh) * 2009-11-18 2016-10-19 曼康公司 单克隆抗体及其诊断用途
US9839910B2 (en) * 2014-09-29 2017-12-12 Illumina, Inc. Fluidic cartridges, systems, and methods for conducting biochemical reactions
WO2016191246A2 (fr) * 2015-05-22 2016-12-01 Memorial Sloan-Kettering Cancer Center Anticorps semblables aux récepteurs de lymphocytes t spécifiques pour un peptide prame

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Publication number Publication date
WO2022229849A1 (fr) 2022-11-03

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