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IT202100021401A1 - IgG/IgM serological rapid test - Google Patents

IgG/IgM serological rapid test Download PDF

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Publication number
IT202100021401A1
IT202100021401A1 IT102021000021401A IT202100021401A IT202100021401A1 IT 202100021401 A1 IT202100021401 A1 IT 202100021401A1 IT 102021000021401 A IT102021000021401 A IT 102021000021401A IT 202100021401 A IT202100021401 A IT 202100021401A IT 202100021401 A1 IT202100021401 A1 IT 202100021401A1
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Italy
Prior art keywords
blood
reagent
test
dispenser
container
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IT102021000021401A
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Italian (it)
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Giuseppe Piccinni
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Giuseppe Piccinni
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Priority to IT102021000021401A priority Critical patent/IT202100021401A1/en
Publication of IT202100021401A1 publication Critical patent/IT202100021401A1/en

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    • 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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502761—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules
    • 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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • 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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/4915—Blood using flow cells
    • 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
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5094—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for blood cell populations
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0631—Purification arrangements, e.g. solid phase extraction [SPE]
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0647—Handling flowable solids, e.g. microscopic beads, cells, particles
    • 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
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0877—Flow chambers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/01—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00148—Test cards, e.g. Biomerieux or McDonnel multiwell test cards

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Ecology (AREA)
  • Cell Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Fluid Mechanics (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Description

DESCRIZIONE DESCRIPTION

nome: Test rapido sierologico IgG/IgM name: IgG/IgM serological rapid test

Campo di applicazione: Field of application:

Il presente trovato si riferisce ad un dispositivo per realizzare analisi rapida di materiale biologico, in particolare siero sanguigno da impiegarsi in associazione con un contenitore. The present invention relates to a device for carrying out rapid analysis of biological material, in particular blood serum to be used in association with a container.

Pi? precisamente il test rapido sierologico IgG/IgM ? un test per il riconoscimento degli anticorpi (nel sangue intero, plasma e siero) sviluppati dal sistema immunitario in caso di infezione da nuovo corona virus 2019-nCOv. Pi? precisely the IgG/IgM serological rapid test? a test for the recognition of antibodies (in whole blood, plasma and serum) developed by the immune system in case of infection with the new 2019-nCOv corona virus.

Il trovato ? un test cosiddetto preliminare di facile attuazione e di veloce lettura che permette la ricerca di anticorpi IgG che permette di dare informazioni sull?eventuale contrazione del virus anche su persone che lo hanno contratto senza saperlo in quanto del tutto asintomatiche successivamente a quando l?infezione ? stata risolta. The found ? a so-called preliminary test that is easy to implement and quick to read which allows the search for IgG antibodies which allows information to be given on the possible contraction of the virus even on people who have contracted it without knowing it as completely asymptomatic after when the infection? been resolved.

La caratterista del trovato ? che unisce in un solo device/dispositivo il test rapido. The characteristic of the invention ? which combines the rapid test in a single device.

Stato della tecnica State of the art

Attualmente esistono dei test rapidi che necessitano la presenza di personale sanitario in quanto devono procedere ad eseguire l?esame attraverso una pluralit? di azioni: la raccolta del sangue o del siero plasma, e successivamente l?inserimento del cosiddetto reagente, dopodich? bisogner? inserire il campione ottenuto nell?apposito dispositivo, ed attendere un tempo, che pu? variare dai 10 ai 15 minuti. Le modalit? di esecuzione delle analisi appena descritte, presentano l?inconveniente di non garantire standard igienici e sanitari adeguati, in quanto il campione di sangue dopo il prelievo subisce diversi travasi da un contenitore all?altro, inoltre, tali modalit? risultano complesse nella misura in cui richiedono una manualit? ed un?attenzione nel dosare le quantit? dei vari liquidi e nell?inserimento del campione nell?apposito dispositivo. Currently there are rapid tests that require the presence of health personnel as they must proceed to perform the exam through a plurality of tests. of actions: the collection of blood or serum plasma, and subsequently the? Insertion of the so-called reagent, after which? need to insert the sample obtained in the appropriate device, and wait for a time, which can? vary from 10 to 15 minutes. The modalities? execution of the analyzes just described, have the drawback of not guaranteeing adequate hygienic and sanitary standards, as the blood sample undergoes various decanting from one container to another after the blood sample; moreover, these modalities? are they complex to the extent that they require manual skill? and a? attention in dosing the quantities? of the various liquids and in the insertion of the sample in the appropriate device.

Mentre il dispositivo del test rapido oggetto del trovato ha il pregio di ovviare agli inconvenienti appena descritti con riferimento alla tecnica nota poich? riunisce tutta la procedura nel singolo dispositivo e pu? essere svolto senza l?intervento di personale paramedico. While the rapid test device object of the invention has the advantage of obviating the drawbacks just described with reference to the prior art since brings together all the procedure in the single device and pu? be carried out without the intervention of paramedical personnel.

Lo scopo dell?invenzione ? quello di ottenere un oggetto compatto, monouso, di facile funzionamento solo meccanico, che permette di praticare la stessa analisi immediata della presenza dell?infezione al virus COVID 19, con l?unica azione di inserire la goccia di sangue intero sull?apposito strumento, secondo la rivendicazione n. 1. The purpose of the invention? that of obtaining a compact, disposable object that is easy to operate only mechanically, which allows you to carry out the same immediate analysis of the presence of the COVID 19 virus infection, with the only action of inserting the drop of whole blood on the appropriate instrument, according to claim no. 1.

Esposizione del trovato Exhibition of the invention

Questo dispositivo costituisce una innovativa modalit? di svolgimento del test rapido, molto semplice, con il solo inserimento della goccia di sangue, contenendo all?interno dello stesso dispositivo tutto il processo per giungere al responso finale. This device is an innovative modality? of carrying out the rapid test, very simple, with only the insertion of the drop of blood, containing within the same device the whole process to reach the final response.

Il dispositivo contiene, quindi, tutti gli elementi compreso il pungidito, il reagente che si attiva in modo meccanico che nell?espandersi in un?apposita camera intercetta la goccia di sangue immessa, giunge nell?area dedicata al responso del test che risulta visibile dall?esterno. The device therefore contains all the elements including the lancing device, the reagent which is activated mechanically and which, as it expands in a special chamber, intercepts the drop of blood introduced, reaches the area dedicated to the test response which is visible from the ?external.

Il test viene attivato attraverso il pungi dito inserito all?apice del dispositivo che attivato permetter? la fuoriuscita di 1 o 2 gocce di sangue dal dito, sangue che verr? inserito nell?apposito tampone (colore rosso fig.2). The test is activated through the finger prick inserted at the apex of the device which, when activated, will allow the leakage of 1 or 2 drops of blood from the finger, blood that will come? inserted in the special plug (red fig.2).

La seconda fase ? l?attivazione del reagente che si avr? con la pressione del tasto meccanico posto all?altra estremit? del pungi dito. Il tasto comprimer? il contenitore causandone la rottura. Il reagente uscir? quindi dal suo ambito e si posizioner? nell?identification streep, allagandola, intercettando cos? la goccia di sangue nel frattempo introdotta nell?apposito tampone. La striscia sensibile (streep) quindi si attiver? e permetter? la lettura del risultato dall?apposita finestrella, che si manifester? dopo circa 10 minuti. The second stage? the activation of the reagent that you will have? with the pressure of the mechanical key placed at? the other extremity? of the finger prick. Will the compress key? container causing it to break. Will the reagent come out? then from its scope and will position? in the identification streep, flooding it, intercepting cos? the drop of blood in the meantime introduced into the appropriate swab. Will the sensitive strip (streep) then activate? and allow? the reading of the result from?the appropriate window, which will manifest? after about 10 minutes.

Illustrazione dei disegni Drawings illustration

Come evidenziato negli allegati disegni il trovato ? monouso e contiene le seguenti parti: As highlighted in the attached drawings, the invention ? disposable and contains the following parts:

i. un involucro plastico che aggrega tutti i vari elementi - fig. A) e figura B) the. a plastic casing that aggregates all the various elements - fig. A) and figure B)

ii. un pungidito interno recuperabile su canali commerciali esistenti e installabile all?interno dell?involucro (1) ii. an internal lancing device that can be recovered on existing commercial channels and can be installed inside the casing (1)

iii. un tasto (dispenser buffer) (2) che si attiva meccanicamente che con la pressione fa rompere il contenitore reagente sottostante (buffer) (3) (sfera o involucro plastico di altra forma in grado di entrare in un volume di 12mmx12mmx6mm) iii. a key (buffer dispenser) (2) which is activated mechanically which, when pressed, breaks the underlying reagent container (buffer) (3) (sphere or other shaped plastic casing capable of entering a volume of 12mmx12mmx6mm)

iv. un blood swab o tampone (4) dove viene immessa la goccia di sangue iv. a blood swab or swab (4) where the drop of blood is introduced

v. un identification streep (5) dove giunger? il reagente unitamente alla goccia di sangue; v. an identification streep (5) where will it reach? the reagent together with the drop of blood;

vi. Una Finestra di lettura del risultato del test (6) you. One test result reading window (6)

Nella figura C) sono riportate le dimensioni del trovato. Figure C) shows the dimensions of the invention.

Esecuzione del Test rapido secondo il trovato Execution of the quick test according to the invention

Come in precedenza evidenziato il trovato, contiene in se ogni elemento per giungere per poter giungere al test rapido, richiedendo unicamente l?inserimento nello spazio dedicato (tampone) della goccia di sangue, contendo la dose di reagente nella qualit? e nella quantit? adeguata. As previously highlighted, the invention contains in itself every element to arrive at the rapid test, requiring only the insertion in the dedicated space (swab) of the drop of blood, contending the dose of reagent in the quality? and in the quantity? appropriate.

Quindi il processo si attiva con il pungidito, che fa fuoriuscire la goccia di sangue che viene posizionata nell?apposito tampone, si attiva il tasto che rompe il buffer posizionato all?interno del dispositivo che allaga all?interno il tampone che porta poi a determinare il risultato dell?esame che verr? letto nella finestra prevista. Then the process is activated with the lancing device, which releases the drop of blood which is placed in the appropriate pad, the button is activated which breaks the buffer positioned inside the device which floods the pad inside which then leads to determine the result of?the exam that will come? read in the window provided.

L?esame sierologico attraverso il modello del trovato potr? essere svolto in qualsiasi momento, in qualsiasi posto, anche in piedi e quindi con una applicazione semplicissima The serological examination through the model of the invention could be carried out at any time, in any place, even standing up and therefore with a very simple application

Claims (3)

RivendicazioniClaims Il dispositivo portatile di analisi rapida di materiale biologico, in particolare siero sanguigno, per uso in associazione con contenitore di detto materiale, per la realizzazione test rapido sierologico IgG/IgM ? caratterizzato dai seguenti elementi:The portable device for the rapid analysis of biological material, in particular blood serum, for use in association with a container of said material, for the realization of the IgG/IgM serological rapid test? characterized by the following elements: 1.- dispositivo, per realizzare test clinici abbinati su liquidi biologici, caratterizzato dal fatto che in uno stesso strumento sono raggruppati e contenuti tutti gli elementi necessari per l?analisi del campione biologico. In particolare, il pungidito (1), posizionato nella parte bassa del dispositivo, che pu? essere estraibile o meno, attiver? la fuoriuscita di sangue che sar? raccolto da un apposito tampone raccogli sangue (4). Dopodich? premendo un tasto a pressione (2) il dispenser del reagente (3) inonder? l?identification streep (5), infine ? previsto il risultato sulla finestra di responso del test (6);1.- device, to carry out combined clinical tests on biological liquids, characterized by the fact that all the elements necessary for the analysis of the biological sample are grouped and contained in the same instrument. In particular, the lancing device (1), positioned in the lower part of the device, which can be removable or not, activater? the spill of blood that will be? collected by a special blood collection swab (4). After that? by pressing a push button (2) the reagent dispenser (3) will flood? the? identification streep (5), finally ? predicted the result on the test response window (6); 2.- Dispositivo come nella rivendicazione 1, caratterizzato dal fatto che il dispenser del buffer si attiva con un tasto a pressione che permette di rompere il contenitore del reagente (3) che viene ad allagare il tampone (4) dove ? stata posizionata la goccia di sangue;2.- Device as in claim 1, characterized in that the buffer dispenser is activated with a push button which allows breaking the container of the reagent (3) which floods the buffer (4) where ? the drop of blood has been placed; 3.- Procedimento per eseguire test clinici abbinati utilizzando un unico dispositivo come nella rivendicazione 1 caratterizzato dal fatto che il reagente viene inserito nelle corrette quantit? in un serbatoio sempre interno al dispositivo semplicemente grazie all?utilizzo di un tasto a pressione, che risulta essere dispenser del reagente stesso (4) contenuto in un contenitore di plastica, una volta che viene rotto dalla pressione del tasto (2) fuoriesce all?interno del dispositivo e allaga il tampone dove viene inserita la goccia di sangue (4) per poi disporre la reazione (5) e poi in un arco temporale di circa dieci minuti l?esito del test. 3.- Process for carrying out combined clinical tests using a single device as in claim 1 characterized by the fact that the reagent is inserted in the correct quantities? in a tank always inside the device simply thanks to the use of a pressure button, which turns out to be a dispenser of the reagent itself (4) contained in a plastic container, once it is broken by pressing the button (2) it comes out all? inside the device and floods the swab where the drop of blood is inserted (4) to then arrange the reaction (5) and then, in a time span of about ten minutes, the test result.
IT102021000021401A 2021-08-20 2021-08-20 IgG/IgM serological rapid test IT202100021401A1 (en)

Priority Applications (1)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100028207A1 (en) * 2008-07-16 2010-02-04 International Technidyne Corporation Cuvette-based apparatus for blood coagulation measurement and testing
US20160245793A1 (en) * 2014-05-31 2016-08-25 Chromedx Corp. Joint spectroscopic and biosensor system for point-of-care testing
US20170326549A1 (en) * 2014-11-26 2017-11-16 Ronald Jones Automated microscopic cell analysis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100028207A1 (en) * 2008-07-16 2010-02-04 International Technidyne Corporation Cuvette-based apparatus for blood coagulation measurement and testing
US20160245793A1 (en) * 2014-05-31 2016-08-25 Chromedx Corp. Joint spectroscopic and biosensor system for point-of-care testing
US20170326549A1 (en) * 2014-11-26 2017-11-16 Ronald Jones Automated microscopic cell analysis

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