EP0912884A1 - Appareil de mesure de la vitesse de sedimentation globulaire (vsg) - Google Patents

Appareil de mesure de la vitesse de sedimentation globulaire (vsg)

Info

Publication number
EP0912884A1
EP0912884A1 EP97940001A EP97940001A EP0912884A1 EP 0912884 A1 EP0912884 A1 EP 0912884A1 EP 97940001 A EP97940001 A EP 97940001A EP 97940001 A EP97940001 A EP 97940001A EP 0912884 A1 EP0912884 A1 EP 0912884A1
Authority
EP
European Patent Office
Prior art keywords
test
tube
reading
esr
light
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.)
Ceased
Application number
EP97940001A
Other languages
German (de)
English (en)
Inventor
Giampiero Curradi
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.)
CDR Srl
Original Assignee
CDR Srl
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
Priority claimed from IT96FI000169 external-priority patent/IT1286674B1/it
Priority claimed from ITFI960076 external-priority patent/IT241238Y1/it
Application filed by CDR Srl filed Critical CDR Srl
Publication of EP0912884A1 publication Critical patent/EP0912884A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • G01N15/04—Investigating sedimentation of particle suspensions
    • G01N15/05—Investigating sedimentation of particle suspensions in blood

Definitions

  • the present invention refers to a ESR test apparatus.
  • the test is performed with a blood sample quantity and a measurement time considerably reduced in respect of the traditional ones.
  • the use of small blood quantities and of a quick measuring method results in particular advantages when emergency applications are required.
  • the kit consists of a main trasparent body inside which several cavities are provided. Each cavity can house a test-tube for ESR test. Before introducing the test-tube, a cylindrical graduated sleeve having at least a flat portion on the lateral surface has to be introduced into the cavity. Obviously, the sleeve presents transversal dimensions intermediate between the test-tube and the cavity dimensions. The operator can vertically displace the sleeve using a transversal rubber-coated pin, frictionally engaged with the flat portion of the lateral surface of the sleeve. Due to the transparency of the body inside which the cavities are placed, moving the sleeve the operator can fix the "0" mark of the graduated scale with the superior blood meniscus level at the starting time of the test.
  • the Italian Patent No. 1 ,192,490 (in the name of Diesse Diagnostica Senese S.r.l.) refers to an ESR test apparatus operating on several samples and comprising: a test-tube holder equipment, able to rotate around an horizontal axis; time control means to move/fix the equipment with the test-tubes in vertical position; and a structure vertically movable in respect of the test-tubes, the structure being provided with photometric sensor means and with information which are related to each test-tube.
  • the apparatus claimed in the Italian Patent allows to use dimensionally reduced test-tubes and subsequently to correlate the results obtained with such test-tubes with the standard values of the traditional 30 cm long pipette of the Westergreen method.
  • This solution is an improvement of the apparatuses described in other documents, but presents some drawbacks substantially consisting in that, to perform the erytrosedimentation level reading, it requires a movable structure carrying the photometric sensor means. It results in complicated displacement devices, which make impossible to obtain an high resolution of the sedimentation level reading, and also involves too long reading times, which are disadvantageous in case of emergency applications. Furthermore, due to the particular reading system adopted, it is necessary to "follow" by photometric sensor means the displacements of the erytrosedimentation level.
  • the apparatus has an unique and prefixed threshold acceptability value of the light quantity received by the sensors which, in presence of some kind of samples, could introduce errors. It is to be noted that the quality and the accuracy of the reading resolution are essential in order to properly correlate the readings obtained with as small as possible test-tubes with the standard reference values of Westergreen. On the other hand, it is evident that the reading resolution has to be the highest possible in order to reduce the test-tube dimensions and the quantity of blood sample required. US patent No.
  • the apparatus according to the invention allows to overcome said prior art drawbacks.
  • Such object has been reached by an apparatus able to read the erytrosedimentation level by a plurality of fixed photometric sensors aligned one after the other and all constituting a unique sensor assembly intended to receive the light from the analyzed test-tube.
  • the reading system is completely at the solid state and does not require the movable mechanisms and transduction systems (light sources and movable sight photocells) of the known methods.
  • the reading sensors employed in the apparatus allow a reading resolution of 125 micron and a continuous electronic scanning of the erytrosedimentation level.
  • the determination of the level is obtained utilizing the signals produced by the optical sensors of the reading assembly, which are placed parallel to the test-tube axis, and by a subsequent numeric processing of the output of each sensor.
  • the sedimentation level position is appreciated inside a reading range of 128 or more aligned points, the number of which depends on the kind and on the number of the choosen sensors, each of them corresponding to a level point.
  • the brightness of each point is measured by a continuous and accurate discrimination of 256 grey levels (when 8 bit A/D converters are employed) inside the erytrosedimentation region, and the sedimentation level is determined.
  • such numeric processing includes an adaptive recognition of the grey level, performed for each reading cell and which allows both to employ more or less trasparent test-tubes and to analyze with the same accuracy blood samples having different trasparency.
  • This specific solution also allows to measure the erytrosedimentation rate of the sample in the test-tube according to two different ways:
  • the apparatus generally includes a light source, constituted for example by a plurality of infrared photoemitter diodes, which illuminates the blood sample contained in a suitable test-tube.
  • the trasmitted light is received by a photoreceiver sensors assembly which is parallel to the longitudinal axis of the test tube.
  • the signals emitted by the photoreceiving sensors are continuously processed in the described way by a microprocessor device, in order to determine the sedimentation level.
  • the displacement rate of such level is measured according to a method (i) and/or (ii) and then correlated to standard ESR values by a suitable correlation table which is realized considering also the relevance of the room temperature measured by a suitable sensor of the apparatus. It is also possible to use a linear sensor CCD (Charge Couple Device) in alternative to said photodiodes arrays.
  • CCD Charge Couple Device
  • the invention comprises a diagnostic sample test-tube allowing a quick ESR analysis with an as small as possible quantity of the blood sample contained in the test-tube and avoiding the "attachment" effect of the blood to the internal walls of the test-tube.
  • said effet is an unsolved problem which causes a delay because the measurement can start only after the fall of blood red corpuscles "attached" to the walls has finished.
  • test-tube having a prismatic hollow body and a cylindrical head of slightly bigger dimensions.
  • the external walls of the body have glazed surfaces to improve the test-tube handling and to allow to append indentification code bar labels.
  • test-tube presents a trasparent portion intended to allow the visual inspection of the proper filling of the blood sample contained in the test- tube.
  • the test-tube can also be provided with a support ring which lifts up the test-tube when the filling is unsufficient (the blood level does not reach as required the receiving sensors quote) and the measurement would not be enabled by the microprocessor unit.
  • test-tube is made of water- repellent material in order to reduce the "attachment" effect of the blood to the internal walls during the preliminary operation of shaking of the sample and to allow the use of small blood sample quantities.
  • fig.1 illustrates a schematic reading cell of an apparatus according to the invention
  • fig.1a shows several reading cells of fig.1 inside a preferred embodiment of the apparatus
  • figs. 2-5 illustrate ESR diagrams
  • figs. 4,5 illustrate ESR diagrams obtained by reading cells employing a linear sensor CCD (Charge Couple Device); figs.
  • CCD Charge Couple Device
  • 6a, 6b illustrate respectively a top view and a side view of a preferred embodiment of the invention, where the horizontal inclination angle ⁇ is shown;
  • fig.7 shows the section AA of fig.6b;
  • fig.8 schematically shows the electronic equipment of the apparatus;
  • fig.9 shows a side view of the test-tube according to the invention;
  • fig.10 shows a second lateral view of the test-tube of fig.1 ;
  • fig.11 shows an enlarged sectional view according to section AA of the test-tube of fig.2;
  • fig.12 shows a test-tube having a closing plug;
  • fig.13 shows a test-tube plug.
  • Fig. 1 schematically shows a reading cell of the apparatus of the invention.
  • a microprocessor device 11 controls all the operations. In particular it controls a reading cell 21 , delimited in the figure by a dotted line, able to appreciate the grey level at the different blood sample quotes and, subsequently, to allow the erytrosedimentation level determination.
  • Cells 21 present driving means 12 of photoemitter diodes 13 and means 14 to amplify, digitally convert and transmit the analogic signals received from fixed optical reading sensors 15, placed at the opposite sides of the test-tube in respect of said photoemitters 13.
  • an apparatus 10 which works with a plurality of samples.
  • the apparatus is able to independently measure the ESR of the different blood samples contained in the test-tubes and which can be simultaneously analyzed.
  • the apparatus comprises several reading pockets 23, each of them is provided with a reading cell.
  • the pockets share the driving device 12 and the means 14 to amplify, convert and transmit the reading signals.
  • several test-tubes (sixteen test- tubes), placed inside an equal number of pockets 23 realized inside a base 24.
  • the base 24 preferably rests on an orizzontal plane Z (in figure 6b plane Z is counter-clockwise rotated of an angle ⁇ to better show the drawing), so that the pockets and the test-tubes have an inclination ⁇ , for example 25°, in order to reduce the required sedimentation time.
  • an orizzontal plane Z in figure 6b plane Z is counter-clockwise rotated of an angle ⁇ to better show the drawing
  • each test-tube 16 is placed between photoemitter diodes 13, preferably infrared emitters, and photoreceiver sensors 15.
  • the test-tube is made of trasparent or translucent material and has two glazed lateral portions usefull to handle the test-tube, or to write words (name and number of the patient) for example by pen, or to append labels with bar codes to be read by the optical pen 22 of fig.8 to identify the patient corresponding to each test-tube.
  • a suitable portion, or window 26, defines the lower limit of the proper filling of the test-tube. Below such limit the apparatus does not perform the measurement.
  • Horizontal curtain filters 27 are used to reduce the action on the sensors of the slanting light beams and consequently increase the resolution capability of the receiving sensors.
  • the apparatus includes a keyboard 28, a digital display 29 and a printer 30, of the known type.
  • test-tubes 16 containing the blood sample are shaked to break possible "rouleaux"; this operation is done manually or automatically by a suitable external shaker if the analysis is not immediately subsequent the blood sample. After shaking, each test-tube 16 is placed inside the reading pocket, so that the corresponding reading sensors can verify its presence and communicate it to the microprocessor unit device.
  • the microprocessor unit verifies that the blood level in the test-tube is above said window limit and abilitates the reading operation. Otherwise, it is reported that the measurement is impossible or that a support ring 37 is required for that test-tube.
  • the spatial limits of the reading range can preferably vary between 16 and 70 mm depending on the kind and on the number of the sensors employed, while the quote reading resolution is preferably of 125 micron, depending only on the specific technology of the reading sensors.
  • the reading sensors 15 of the apparatus 10 have a common clock signal input 9.
  • Each reading sensor 15 of the reading cells is constituted by a plurality of superimposed and aligned photoreceiver diodes which receive the light transmitted by the illuminated sample and produce analogic signals. Each signal corresponds to the grey level of the sample quote at which the sensor is positioned.
  • the analogic signals are amplified, digitally converted by a D/A converter, and transmitted to the unit 11 by a common device 14.
  • the software implemented in the microprocessor unit 11 measures continuously and with accuracy the light received by the different aligned diodes of each reading cell.
  • the values measured are utilized to determine the erytrosedimentation level in the test-tubes. For example, such level is determined associating it to brightness variation of a predetermined intensity of the light received by two or more adjacent diodes.
  • this solution does not require the definition of a reference threshold value of light and shade, which always introduces a wide margin of error. It is also provided an adaptive recognition signal processing which makes the correct reading of each cell independent from the optical characteristics of the test-tube and of the blood samples.
  • the processing can consist, for example, in the determination of a brightness variation value, which the sedimentation quote level of each test-tube is associated to.
  • the continuous scanning and the reading self-adjustment allows to employ test-tubes made of water-repellent material, for example polypropylene, which are cheap and suitable to the specific test to be performed because they present a reduced "attaching" effect to the test-tube walls after the initial shaking.
  • test-tubes made of water-repellent material for example polypropylene
  • Such materials have never been used in the automatic apparatuses because their opacity involves too wide margins of error in the light/shade threshold recognition when in presence of a non-continuous digital (0/1 ) reading of the grey level.
  • the electronic equipment of the apparatus comprising a microprocessor unit 11 connected to the following components: a bar code reader 22 constituted for example by an optical pen; two groups each comprising eight receiving sensors assemblies 15 associated to an equal number of reading pockets.
  • the pockets are provided with lighting bicoloured red/green LED controlled by the unit 11 and used to notify to the user when each test is finished; an assembly of sixteen photoemitters 13 and a room temperature sensor 34; a printer 30; a keyboard 28; a display 29; a supply line 32 and serial line 33 for possible connection to an external computer.
  • the linkage to a connector 31 for microchip cards is also shown.
  • the apparatus is able to flexibly perform several functions on the basis of specific data encoded on a microchip card and processed by the unit 11.
  • the card is a validation key of the apparatus; to associate a group of patients to a specific measurement test; to verify the number of the tests performed or of the test-tubes utilized; to update as required the functional parameters of the apparatus.
  • a still further characteristic of the invention is the possibility to modularly expand the apparatus by external lines 36 and connecting the electronic equipment of an apparatus acting as "master” to one or more peripherical "sleeve” apparatuses assembled without keyboard, display and printer, and which send to the master apparatus the data of the tests performed.
  • figure 2 shows in abscissa the reading time expressed in minutes and, in ordinate, the erytrocites level position.
  • the sedimentation process has a roughly linear behaviour starting after a first step in which the observed phenomenon is influenced by the red blood corpuscles turbolence due to the initial shaking. After a first period (approximately 2-3 minutes) during which the phenomenon can have an opposite dynamic (raising of the sedimentation level) due to the red blood corpuscles which fall from the internal walls of the test-tube, the erytrocites level has an appromixately linear lowering.
  • the initial raising effect can be considerably reduced by a suitable choice of the test-tube shape and material.
  • the apparatus can appreciate the dynamic of that particular process, because it continuously controls the phenomenon and abilitates the zero point reading and the erytrosedimentation rate measurement only when the increasing of the stops and the diagram behaviour becomes monotone.
  • the apparatus functioning is based on the measurement of the erytrosedimentation level lowering rate in a predetermined time or distance, and on a subsequent correlation of such data with clinical reference values. For example, measuring the time required for a 5 mm displacement of the sedimentation level, it is possible to obtain a rate value to be correlated to the clinical parameter.
  • the apparatus 10 can be connected to a room temperature sensor 34 to adjust the measurements which are influenced by the room temperature.
  • the system can be provided with an external shaking device to automatically shake the blood samples;
  • infrared transparent curtain filters can be adopted on the receiving sensors, and possibly on light sources, to increase the protection against the external light.
  • Fig.3 the ordinate value expressed as "digit" corresponds to the sensor resolution, in the present case 125 micron.
  • the figure shows only the linearized behaviour of the diagrams of figure 2, between approximately 3 and 6 minutes, for various ESR values.
  • a test-tube according to the invention is constituted by an elongated prismatic hollow body 100, on which a cylindrical hollow head 200 is superimposed.
  • the front and rear walls 120 of the body 100 have slightly bigger dimensions than the lateral walls 110 and present a glazed portion, represented in figure 9 by hatching, which has a polished zone, or window 130, in the upper part of body 100.
  • the lateral walls 110 are trasparent to allow the light passage and one of them presents a reference mark 190 impressed on the upper part.
  • the body 100 presents a slightly conical external outline, while the internal cavity has a constant section.
  • the head 200 presents a cavity constituted by a cylindrical part 140 for the insertion of a closing plug 170 and a lower part 150 which remains available to facilitate the shaking of the sample contained in the test-tube.
  • the test-tube contains an anticoaugulant product and is made of water-repellent material, preferably PET ®, polypropylene, polyethylene or nylon for food applications.
  • Preferred dimensions of the body 100 are: length approximately 45 mm; internal cavity section 4X6 mm.
  • the very small dimensions of the test-tube are useful to be used in the described apparatus performing many simultaneous tests.
  • the test-tube is particularly advantageous to be used with the described light sources and photometric sensors placed at the opposite sides of the test-tubes.
  • the sensors are placed along a measurement window (in the described test-tube it is a portion of the side walls 110) having dimensions correlated to the sensors dimensions (a few mm of length) and which have to be as small as possible to reduce the required blood quantity of each sample.
  • the front and rear walls 120 have a bigger width in order to extend the optical path of the light through the sample and to improve the measurement reliability with a determined blood quantity.
  • a closing plug 170 is shown, which is inserted inside the cavity 140 of the head 200 to leave an available free space sufficient to allow the sample shaking.
  • Plug 170 presents a lateral groove 180 through which vacuum can be created before closing the test-tube.
  • the vacuum allows to fill a suitable dose of blood from a butterfly shaped sampling valve, without opening the plug and to avoid any risk for the user to touch the contained blood.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un appareil de mesure de la VSG comportant plusieurs sources lumineuses (13) éclairant l'échantillon sanguin contenu dans un tube à essai (16) approprié, la lumière émise étant reçue par plusieurs photorécepteurs (15). Les signaux reçus par les photorécepteurs sont traités de façon continue par un microprocesseur (11) afin qu'il soit possible de déterminer la position instantanée du niveau de sédimentation globulaire et par conséquent sa vitesse de déplacement.
EP97940001A 1996-07-16 1997-07-16 Appareil de mesure de la vitesse de sedimentation globulaire (vsg) Ceased EP0912884A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
ITFI960169 1996-07-16
IT96FI000169 IT1286674B1 (it) 1996-07-16 1996-07-16 Apparecchiatura per la misurazione della velocita' di eritrosedimentazione (ves) di campioni di sangue
ITFI960076 IT241238Y1 (it) 1996-07-16 1996-07-16 Provetta per saggi diagnostici
ITFI960076U 1996-07-16
PCT/EP1997/003798 WO1998002726A1 (fr) 1996-07-16 1997-07-16 Appareil de mesure de la vitesse de sedimentation globulaire (vsg)

Publications (1)

Publication Number Publication Date
EP0912884A1 true EP0912884A1 (fr) 1999-05-06

Family

ID=26330548

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97940001A Ceased EP0912884A1 (fr) 1996-07-16 1997-07-16 Appareil de mesure de la vitesse de sedimentation globulaire (vsg)

Country Status (3)

Country Link
EP (1) EP0912884A1 (fr)
AU (1) AU4201597A (fr)
WO (1) WO1998002726A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001023864A1 (fr) * 1999-09-27 2001-04-05 Adelio Missaglia Appareil pour tester les echantillons sanguins
US7207939B2 (en) 2002-10-03 2007-04-24 Coulter International Corp. Apparatus and method for analyzing a liquid in a capillary tube of a hematology instrument
ITFI20030254A1 (it) 2003-10-08 2005-04-09 Actis Active Sensors S R L Metodo e dispositivo perfezionati per l'analisi spettrale
CA2543290C (fr) * 2003-10-28 2014-07-22 Diesse Diagnostica Senese S.P.A. Dispositif pour la conduite d'analyses sur des fluides biologiques, et procede connexe
SE531510C2 (sv) 2007-09-04 2009-05-05 Tommy Forsell Blodanalys
AU2017314763B2 (en) * 2016-08-22 2021-09-02 Commonwealth Scientific And Industrial Research Organisation Automatic sedimentation and separation curve generator
CN113049457A (zh) * 2021-04-28 2021-06-29 深圳市亚辉龙生物科技股份有限公司 采血管中红细胞高度检测方法

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Publication number Priority date Publication date Assignee Title
US4392497A (en) * 1980-12-02 1983-07-12 Ghaussy Rahmat U Erythrocyte sedimentation rate apparatus and method
IT1192490B (it) * 1982-08-10 1988-04-13 Diesse Diagnostica Senese Srl Apparecchio per la determinazione della velocita' di eritrosedimentazione del sangue (ves) su di una pluralita' di campioni
FR2566126B1 (fr) * 1984-06-13 1988-05-06 Cinqualbre Paul Procede et appareil pour la determination, l'affichage et l'impression en automatique de la vitesse de sedimentation des particules en suspension dans un liquide biologique
NL8801140A (nl) * 1988-05-02 1989-12-01 Theodorus Schouten Inrichting voor het bepalen van de bloedbezinkingssnelheid van bloedmonsters.
US5003488A (en) * 1989-03-10 1991-03-26 Gespac, Inc. Automatic fluid sedimentation rate measurement apparatus and method
IT217679Z2 (it) * 1989-09-26 1992-01-16 Diesse Diagnostica Apparecchio per la determinazione della velocita' di eritrosedimentazione (ves) ed altro
IT1246993B (it) * 1991-01-10 1994-12-12 Diesse Diagnostica Provetta per analisi biologiche munita di dispositivo di controllo, di efficienza e di posizione, per letture fotometriche.
DE9216127U1 (de) * 1992-11-29 1994-04-07 Orth Helmut Prof Dr Gerät zur Messung der Blutsenkung

Non-Patent Citations (1)

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Title
See references of WO9802726A1 *

Also Published As

Publication number Publication date
WO1998002726A1 (fr) 1998-01-22
AU4201597A (en) 1998-02-09

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