Device and method for measuring the erythrocyte sedimentation rate from a blood drop and corresponding kit

Abstract

A manual device (10) for measuring the erythrocyte sedimentation rate from a drop of blood taken from a finger prick, comprises a containment body (11), a reading chamber (20) located inside the containment body (11) and comprising a radiation emitter (40) and a corresponding radiation detector (50), and a fluidic channel (22), which extends from an inlet aperture (23), made through between the radiation emitter (40) and receiver (50), and configured to receive a blood sample consisting of a drop of a few microliters. The manual device (10) can be part of a kit.

Description

[0001] “DEVICE AND METHOD FOR MEASURING THE ERYTHROCYTE SEDIMENTATION RATE FROM A BLOOD DROP AND CORRESPONDING KIT”

[0002]

[0003] FIELD OF THE INVENTION

[0004] The present invention concerns a reading device for measuring the erythrocyte sedimentation rate (or ESR), the corresponding measuring method and the corresponding kit.

[0005] In particular, the present invention concerns the possibility of measuring the ESR starting from a single drop of blood.

[0006] BACKGROUND OF THE INVENTION

[0007] The ESR is a well-established and known test for the detection of a general inflammatory state. The reference method, known as the Westergreen method, is performed by sedimentation of a blood sample and the result is obtained after about one hour from filling a tube. The method was implemented over time by the Applicant and was speeded up in order to obtain the result in just 20 seconds. A test time of just 20 seconds allowed to integrate the ESR into blood cell counter type systems, so as to optimize a workflow obtainable from a blood collection tube with EDTA.

[0008] Around 400 million tests are performed worldwide every year using the Westergreen method and partly with automated systems.

[0009] One problem is that ESR measuring devices are generally stand-alone in which blood sample treatment lengthens the time necessary to obtain the measurement result. For example, with known devices, after collecting a blood sample, it is necessary to introduce it into a laboratory device to perform the measurement, and, once the measurement is complete, it is necessary to empty the blood introduced into the tubes that are inside the devices.

[0010] Add to this the problem of possible contamination between subsequent blood samples.

[0011] Moreover, these known devices are often placed in laboratories, but there are no solutions for medical clinics or usable by users themselves, without the assistance of medical personnel.

[0012] Another disadvantage of known devices for measuring the ESR is the need to collect large volumes of blood that could be reduced further, albeit by a few milliliters.

[0013] US-A1-2024 / 192126 discloses a manual device and method for analyzing a blood sample, equipped with a capillary tube that can be inserted into a spectrometer to be analyzed. This device does not comprise a radiation emitter and receiver, these elements being described as being external to this device.

[0014] US-A1-2001 / 266778 discloses a cartridge in which a capillary tube is inserted, for collecting and analyzing a blood sample taken directly from a drop of blood. This cartridge is provided for sample collection only, and requires an external analysis apparatus. Therefore, the cartridge is not equipped with a radiation emitter and receiver.

[0015] US-A 1-2016 / 216284 discloses a cartridge containing a tubular shaped fluidic channel configured to house a capillary tube. The cartridge is configured to house only a small part of the capillary tube and also provides its own channel for the outflow of the sample until it reaches two reading chambers. The cartridge also comprises electromagnetic wave receivers, located upstream of the reading chambers, and therefore separately therefrom.

[0016] US-A-6 106780 discloses a portable device for analyzing a blood sample, which is however configured to house strip-shaped sample holders containing a swab inside them to receive the body fluid sample.

[0017] US-A1-2020 / 340888 concerns a portable device with disposable samplecarrying tubes, for measuring the level of glucose in the blood, but not for measuring the ESR. The sample-carrying tube contains, in an internal channel thereof, a reading zone in which a reagent that changes color after reacting with the blood is immobilized. Measurements are performed when the sample is stationary.

[0018] There is therefore the need to perfect a device for detecting and measuring the ESR, as well as a corresponding measuring method, which can overcome at least one of the disadvantages of the state of the art.

[0019] To do this, it is necessary to solve the technical problem of providing a device and a corresponding method which allow to measure the ESR and obtain the results without any specialized personnel.

[0020] In particular, one purpose of the present invention is to provide a device and the corresponding method for measuring the ESR which allow both to collect the sample and also to access the final result autonomously, without specialized personnel.

[0021] Another purpose of the present invention is to provide a device, and the corresponding method, for measuring the ESR which allows to record the results obtained autonomously and automatically.

[0022] The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

[0023] SUMMARY OF THE INVENTION

[0024] The present invention is set forth and characterized in the independent claims. The dependent claims describe other characteristics of the present invention or variants to the main inventive idea.

[0025] In accordance with the above purposes and to solve the technical problem described above in a new and original way, also achieving considerable advantages compared to the state of the prior art, a device according to the present invention for measuring the erythrocyte sedimentation rate from a drop of blood taken from a finger prick comprises a containment body, a reading chamber inserted inside the containment body, containing a radiation emitter and a corresponding radiation detector, as well as a fluidic channel made through between the emitter and the receiver, suitable to receive a blood sample. The device is manual, that is, portable. It does not need to be placed in a fixed position or plugged in to a power supply to operate.

[0026] In accordance with one aspect of the present invention, the fluidic channel is configured to stably and removably receive a capillary tube suitable to contain the blood sample, and the device is equipped with means for communicating and receiving data with external elements. The external elements are preferably external devices.

[0027] Doing so achieves at least the advantage of being able to communicate the ESR measurement results to external elements, which allows to display these results even in a very short time.

[0028] In particular, the capillary tube is insertable into and removable from the fluidic channel without the aid of any type of tool whatsoever, and does not require any other operation, such as the removal of a block or cap for example. The sizes of the fluidic channel and of the capillary tube can be such that the insertion of the capillary tube into the fluidic channel is stable by interference. Optionally, an element for retaining the capillary tube, or for holding it in position, can be provided at the bottom of the fluidic channel.

[0029] The device exploits the capillary effect inside the capillary tube to move the blood sample in the fluidic channel. The ESR detection function can be performed without any pump of any type whatsoever, in particular a peristaltic pump, suitable to move the sample inside the reading chamber. The device according to the invention is in fact without a pump or any other type of mean for moving the blood sample in the capillary tube, or even the capillary tube itself.

[0030] In accordance with one embodiment, the means for communicating and receiving data provide an antenna, which can be configured to communicate the data to an external device equipped with data processing means, such as a computer or smartphone for example.

[0031] According to an alternative embodiment, the means for communicating and receiving data comprise a reader configured to read a readable element of a card. For example, the card can be equipped with a chip. This also allows to unequivocally link the data with a patient, to whom the card can be univocally traced back to.

[0032] In accordance with some embodiments, the fluidic channel extends from an inlet aperture, and the reading chamber is positioned, inside the containment body, with the fluidic channel perpendicular to a wall of the containment body, and with the inlet aperture aligned with a through insertion aperture for inserting the capillary tube.

[0033] In accordance with some embodiments, the device contains at least one circuit board inside the containment body. Advantageously, there are two circuit boards, of which a first circuit board is dedicated to the device’s operation and to performing the ESR measurement, while a second circuit board is dedicated to the device’s power supply as well as data communication.

[0034] The analysis step provides a stop and flow type analysis of the blood sample, performed however within a micro fluidic channel (or channels). Advantageously, the microfluidic channel is constituted by the capillary tube, in particular by its internal channel.

[0035] For example, the analysis step provides a sub-step of outflow of the blood sample into the capillary tube located inside the device for measuring the erythrocyte sedimentation rate, followed by a sub-step of stopping the blood sample so that a part of the blood sample remains stationary in the reading chamber, a step of emitting and detecting a radiation beam, by means of the emitter and detector, in order to measure the erythrocyte sedimentation rate in the blood sample.

[0036] In particular, the sub-step of outflow of the sample occurs exclusively through capillary action, or capillary suction of the sample into the internal channel of the capillary tube. The sub-step of stopping the sample occurs through interruption of the capillary suction, for example, because the sample reaches the other end of the capillary tube, or because of an obstacle suitable to stop the outflow.

[0037] In accordance with some embodiments, the method provides, during the step of emitting and detecting the electromagnetic or acoustic radiation beam, a step of measuring the erythrocyte sedimentation rate, which advantageously provides to detect the presence of (macro)aggregates or roleaux in the blood sample. The presence of aggregates or roleaux allows to determine the erythrocyte sedimentation rate.

[0038] The blood sample collection step is performed with a single drop of blood. The blood sample collection step provides to place a free end of a capillary tube in contact with a drop of blood. Preferably, the drop of blood is obtained by pricking the skin, for example, in correspondence with the tip of a finger, with the aid of a finger prick lancet, for example.

[0039] In accordance with some embodiments, the method provides that the capillary tube is already inserted in the device for measuring the erythrocyte sedimentation rate when the blood sample is collected.

[0040] In accordance with some embodiments, the method provides to communicate the results of the measurement to a processing unit, by means of the communication module.

[0041] In accordance with another aspect, a kit for measuring the ESR comprises a device for measuring the ESR as disclosed above and one or more capillary tubes for collecting a blood sample, and can comprise a finger prick lancet. The capillary tube is made of plastic, glass, or suchlike. In particular, it is rigid. Advantageously, the capillary tube is of the disposable type. Advantageously, the capillary tube has a round, square, or rectangular section.

[0042] The ESR testing directly from a blood drop is innovative in its method and its application for POC or DO, and self-testing by any person or patient whatsoever. The test also finds application in the pediatric field thanks to its simplicity of execution and the minimal amount of blood collected using the device.

[0043] The present patent application concerns both the technical structure as well as the type of native blood sample collected from a finger prick using a lancet.

[0044] DESCRIPTION OF THE DRAWINGS

[0045] These and other aspects, characteristics and advantages of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein: - fig. 1 A is a perspective view of a variant of a device for measuring the erythrocyte sedimentation rate according to the present invention;

[0046] - fig. IB is a three-dimensional section view of the device for measuring the erythrocyte sedimentation rate of fig. 1 A;

[0047] - figs. 2A and 2B are three-dimensional section views of a reading chamber for a device for measuring the ESR according to the present invention, without and with a radiation emitter and receiver, respectively;

[0048] - figs. 3 A and 3B are views, similar to those of figs. 1A and IB, of another embodiment of a device for measuring the erythrocyte sedimentation rate.

[0049] We must clarify that the phraseology and terminology used in the present description, as well as the figures in the attached drawings also in relation as to how described, have the sole function of better illustrating and explaining the present invention, their purpose being to provide a non-limiting example of the invention itself, since the scope of protection is defined by the claims.

[0050] To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can be conveniently combined or incorporated into other embodiments without further clarifications. DESCRIPTION OF SOME EMBODIMENTS OF THE PRESENT INVENTION

[0051] With reference to figs. 1A, IB, 2A and 2B, a device 10 for detecting the ESR, according to the present invention, is of the manual type and comprises a containment body 11 and also a reading chamber 20 located inside the containment body 11.

[0052] The reading chamber 20 (figs. 2 A and 2B) provides a parallelepiped shape body 21 , in this case with a rectangular cross-section, in which there is a fluidic channel 22 configured to receive, in a stable and removable manner, a capillary tube 30. The fluidic channel 22 extends from the inlet aperture 23, made in a wall of the body 21 , to a bottom 24 configured to block the travel of the capillary tube 30. The inlet aperture 23 has a truncated conical shape, so as to form a lead-in 23 A suitable to facilitate the insertion of the capillary tube 30 into the fluidic channel 22.

[0053] The fluidic channel 22 can for example have an internal diameter of 0.9 mm, so as to conveniently house a capillary tube 30 with an internal diameter of 0.8 mm, for example. In this way, the capillary tube 30 is easily insertable in the fluidic channel 22 and, once inserted, remains stably in position thanks to the interference with the internal wall of the fluidic channel 22. The capillary tube 30 is then just as easily extractable from the fluidic channel 22.

[0054] The internal channel of the capillary tube 30 is without any element or agent immobilized on its internal surface, so as not to alter or prevent the normal outflow of the blood through capillary action. This guarantees a correct ESR measurement. In this embodiment, the reading chamber 20 comprises a first seating 201 for installing an emitter element 40 and, aligned therewith in a direction transverse to the fluidic channel 22, a second seating 202 for installing a receiver element 50 (fig. 1). Each of these seatings 201, 202 is located in a corresponding wall of the body 21, opposite each other so that the seatings 201, 202 are aligned with, or at least counter facing, each other.

[0055] The emitter 40 and receiver 50 element can be LEDs, or photodiodes, but in general they are electromagnetic radiation elements mating each other. Emitter and receiver elements for other types of radiation, such as optical or acoustic radiation for example, can also be provided.

[0056] In the example shown, the first seating 201 and the second seating 202 have a substantially circular shape (fig. 2A). These elements, and therefore the corresponding seatings 201, 202, can be of any shape and size whatsoever.

[0057] A corresponding aperture 203, 204 is provided in a preferentially central position of each of the seatings 201, 202.

[0058] The apertures 203 and 204 can be provided, again with respect to the seatings 201 and 202, in a position that is not central, or in different positions from each other.

[0059] However, regardless of their individual position, it is necessary for the apertures 203 and 204 to at least be axial, for a portion part thereof.

[0060] The apertures 203 and 204 can have different shapes, even different from each other.

[0061] A transparent protection element 205, 206 is inserted in each of the apertures 203 and 204, thus allowing the electromagnetic radiation to pass from the emitter 40 to the receiver 50, without interfering with them.

[0062] The protection elements 205 and 206 are not provided if the apertures 203 and 204 have the transparent protection therein.

[0063] The protection elements 205 and 206 can be provided directly in the capillary tube 30, so that when the capillary tube 30 is inserted into the channel 22 and ends its travel with the shoulder 25, the protection elements 205 and 206 are positioned in correspondence with the apertures 203 and 204.

[0064] The bottom 24 of the fluidic channel 22 is delimited by a circular shoulder 25, which acts as an end-of-travel for the capillary tube 30 (fig. 1). Downstream of the circular shoulder 25 there is provided a secondary channel 26 with a smaller diameter than the fluidic channel 22. The secondary channel 26 extends to the wall of the body 21 which is opposite the wall where the inlet aperture 23 is made. In this way, the totality of the channels 22 and 26 completely passes through the body 21 from the inlet aperture 23 to the outlet aperture 27.

[0065] The difference in diameter between the channels 22 and 26 preferably corresponds to the thickness of the material constituting the capillary tube 30. This ensures that there is fluid dynamic continuity throughout the length of the channels 22 and 26 despite the narrowing, and that there are no zones in which a portion part of the improperly analyzed blood sample will stop.

[0066] In this way, there is a vent aperture that, by allowing the air to pass, allows the suction of the blood sample into the capillary tube through capillary action.

[0067] Alternatively to the travel stop of the capillary tube 30 consisting of the shoulder 25, it is possible that the fluidic channel 22 has a same diameter for its entire length, that is, between the apertures 23 and 27. In this case, the capillary tube 40 will have, in its terminal part, a geometric shape corresponding to and opposing the geometric shape 23A, so that it functions as an end-of-travel.

[0068] In this case, the tube 30 can have a length equal to the distance between the apertures 23 and 27, or a shorter length, in any case never smaller than the distance between the inlet aperture 23 and the apertures 203 and 204.

[0069] Figs. 2A and 2B show a first embodiment of the device 10 for measuring the ESR.

[0070] In this embodiment, the device 10 for measuring the erythrocyte sedimentation rate has a parallelepiped shape body 11 with a rectangular or substantially rectangular base, in which the reading chamber 20 referred to in figs. 9, 10 and 11 is positioned. The body 11 consists of two half-shells 110, 111, each having a main wall 110A, 111 A from which there extend two longitudinal lateral walls HOB, 11 IB and two transverse lateral walls 110C, 111C which couple to each other. The half-shell 110 serves as a container for the functional components of the device 10, since they are mainly attached on the internal surface of its main wall 110A (fig.

[0071] 2B) while the half-shell 111 mainly acts as a cover.

[0072] In particular, the reading chamber 20 is, albeit indirectly, attached inside the main wall 110A of the half-shell 110, in particular with the inlet aperture 23 of the fluidic channel 22 oriented facing the lateral wall HOC preferably closer to the reading chamber 20, so that the capillary tubes 30 have a sufficient length to be inserted all the way to the bottom of the fluidic channel 22, and in any case exit from the body 11 (figs. 2A and 2B).

[0073] For this purpose, on the corresponding lateral wall HOC there is provided a through hole 112 which is advantageously aligned with the inlet aperture 23 and the fluidic channel 22 of the reading chamber 20. In the example shown, the reading chamber 20 is located in proximity to a transverse lateral wall HOC, in which the through hole 112 is made.

[0074] The functional components of the device 10 are attached inside the half-shell 110. In particular, in the example shown, the functional components provide a first circuit board 70 and a second circuit board 80. The first circuit board 70 is dedicated to performing the erythrocyte sedimentation rate analysis. For this purpose, the elements that allow to perform the test, in particular the reading chamber 20 (fig. 12B), and the processing of the result are attached on the first circuit board 70. These elements can comprise processing units on which a corresponding software is installed and executable, to command the reading and acquisition of the data as well as its processing in order to output the final result. The second circuit board 80 is dedicated to the power supply of the device 10 and to sending and receiving communications with external elements. The device 10 comprises an antenna 81 for emitting and receiving data to and from external devices E, for example a smartphone, as shown in figs. 2A and 2B. The antenna 81 is positioned on the lateral wall 110C opposite the one in which the capillary tube 30 is inserted; other dispositions can however be provided. The antenna 81 is electrically connected to the second circuit board 80 so as to be driven and powered thereby.

[0075] The second circuit board 80 also comprises at least one communication block 82 containing a communication port, for inserting therein a cable or a device with storage memory, such as for example a USB stick or SD card or suchlike, as well as a power supply block 83 containing a power supply port to which to connect a power supply cable, for the direct power supply of the device 10 or for recharging a battery of the device 10. These blocks are advantageously provided in correspondence with an edge of the second circuit board 80, so that the communication port and the power supply port are accessible through the second half-shell 111, in particular one of its lateral walls 11 IB, 111C (in this case it is the transverse lateral wall 111C in correspondence with the antenna 81). The two circuit boards 70, 80 are electrically connected to each other. It can also be provided that they are in a single piece, as long as there is an electrical connection between them.

[0076] In this variant, the antenna 81 allows to communicate the results on an external device E, so that they can be displayed on that external device E. We must clarify that the device 10, in this specific variant, does not have an integrated display. This makes this variant suitable to be used by a patient, who could perform the erythrocyte sedimentation rate test autonomously, without medical personnel. Figs. 3 A and 3B show a second embodiment of the device 10 for measuring the ESR, which differs from the previous embodiment in that the antenna is not provided, but a display 12 is. A card 91 reader 90 is also provided, for example of the type equipped with a reading chip 92, or other type of readable element. The reader 90 is connected to the second circuit board 82, through its own circuit board 93 to which it is directly attached (fig. 3B). In the example shown, the reader 90 is positioned between the second circuit board 80 and the main wall 110A of the halfshell 110.

[0077] To allow the card 91 to be inserted into the reader 90, a shaped aperture 94 is provided on one of the lateral walls HOB, HOC of the first half- shell 110 (fig.

[0078] 13 A), obviously aligned with the reader 90.

[0079] The display can be provided on the main wall 111 A of the second half shell 111, for reading convenience.

[0080] This variant is particularly suitable for use in a physician’s office or an accident and emergency unit. The reader 90 can be enabled to manage credit card payments or suchlike. It can also be provided that the reader 90 is able to read cards 91 of the smart card type that are attributable to the doctor who has the device 10 available, or to the patient. We must clarify that, in this variant, the communication block 82 and the power supply block 83 described above are provided.

[0081] The operation of the device 10 for measuring the ESR described heretofore, which corresponds to the method according to the present invention, comprises the following steps.

[0082] The device 10 performs the test using a disposable capillary tube 30 for the collection of a blood sample S. The capillary tube 30 is first inserted into the fluidic channel 22 through the inlet aperture 23 until its end-of-travel.

[0083] The skin of a patient is pricked, for example on a finger, to let out a single drop of blood, in a known manner by means of a finger prick lancet, and the free end of the capillary tube 30 is placed in contact with the drop. The blood begins to flow into capillary tube 30 through capillary action.

[0084] The blood in the capillary tube 30 flows into the reading chamber 20, in particular along the fluidic channel 22, and stops automatically. When it stops, a part thereof is positioned between the emitter 40 and the receiver 50, which measure the ESR in a time of approximately 10 seconds.

[0085] The blood sample reading function and the calculation algorithm records the blood flow during suction into the capillary tube 30 until the blood sample stop. The classic flow and stop function for measuring the ESR is generated by the capillary effect in the capillary tube 30 (flow) and automatically stopped (stop). The ESR calculation is then performed using a dedicated algorithm. At the end of the calculation, the result is communicated to an external device E by means of the antenna 81 or shown on the display 16 (figs. 3 A and 3B), for example in the form of a numerical value possibly accompanied by a wording of the type “High ESR”, “Medium ESR” or “Low ESR”, for an immediate visual result of the patient’s inflammation state. In this latter possibility, the results can also be transferred to the card 91 via the reader 90. By means of the same card it is also possible to link the test performed to a patient, whose identity can be found thanks to the card 90.

[0086] The mathematical algorithm of the device 10 for measuring the ESR is comparable in its results to a classic Westergreen sedimentation system according to NCLS standards.

[0087] The measured and calculated data can be stored on a phone with a dedicated app, in order to monitor the various tests performed and self-tests over time, for the attending physician to check.

[0088] The reading device 10 can also be used upon admission by an accident and emergency doctor, at the patient’s bedside or for blood donors who have to be in good health without having inflammatory states for which the ESR is a test recognized as a marker of generic inflammation.

[0089] Among other advantages of the reading device 10, using blood drop sample collection improves the operating standards of the critical issues described by NCLS in various technical and operational aspects indicated below.

[0090] The blood drop test is not subject to laboratory room temperature control, since the test is performed at the time of the finger pricking using a lancet and of the sample S collection.

[0091] The blood drop test is also not subject to the use of any anticoagulant, since the test is immediate from the time mentioned above.

[0092] The blood drop G test is not subject to any need to mix the blood sample S, and thus detect the formation of roleaux characteristic for ESR measurement. The roleaux are detected during blood flow in the stop timing.

[0093] The device 10 also performs the ESR value reading function at 3 levels: low, border line, high, to facilitate the identification of the patient’s status. Specifically, after the ESR test, in addition to the numerical value readable on the display, the words “low”, “border line” or “medium”, or “high”, will also appear.

[0094] The operational functions of the device 10 can be verified by using lactics to monitor the correct technical operation. Control lactics are validated on other instrumentation, in a known manner.

[0095] The device 10 is a portable instrument and therefore usable in all self- testing control contexts to monitor one’s self, or migrant flows, or refugee camps or airport checks.

[0096] The device 10 is practical, simple to use and the cost of the test is attributable to the value of the disposable capillary.

[0097] The device 10 has a production cost compatible with a use by organizations such as the WHO, for poor countries and therefore also has a social economic function of great advantage compared to any existing instrument on the market.

[0098] It can be seen from the foregoing description that the present invention, in addition to speeding up the analysis times to obtain an ESR value, allows to miniaturize a device 10 for measuring the ESR and to simplify its use to the extreme, even with regard to obtaining the blood sample S. This makes the device 10 for measuring the ESR usable even in the absence of medical personnel, for example at home. The reading device 10 can also be used, as well as for humans, also on animals.

[0099] For this reason, a kit is provided containing a device 10 for measuring the ESR as described above and at least one capillary tube 30, preferably packaged in a protective packaging. It can be provided that the kit also contains a finger prick lancet.

[0100] Regardless of the embodiment of the device 10 for measuring the erythrocyte sedimentation rate, it has been verified that with a capillary tube 30 with an internal diameter equal to 0.8 mm and a length of 10 cm, if the capillary tube 30 is placed in the vertical position (with upward suction) a blood filling path 2 cm long is obtained, if the capillary tube 30 is oriented in an oblique direction between the horizontal and vertical, the length of the blood filling path is 3.5 cm, and it is 8 cm long if the capillary tube 30 is in the horizontal position.

[0101] It has also been verified that, on average, the filling of the capillary tube 30 as indicated above took about 4 seconds. Under these conditions, one can expect to obtain the final reading result in approximately 10 seconds. It can therefore be provided to have an operation of the device 10 in which the pressure on the first button 15 determines the start of the suction and the initial time TO of the reading process, this reading can be started after 4 seconds, based on the checks carried out and, after 8-10 seconds, the result of the reading is displayed.

[0102] It is clear that modifications and / or additions of parts may be made to the device 10 for measuring the ESR and to the method as described heretofore, without thereby departing from the field and scope of the present invention, as defined by the claims.

[0103] It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art will be able to achieve other equivalent forms of device and method for measuring the erythrocyte sedimentation rate from a drop of blood and corresponding kit, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

[0104] In the following claims, the sole purpose of the references in brackets is to facilitate their reading and they must not be considered as restrictive factors with regard to the field of protection defined by the claims.

Claims

CLAIMS1. Manual device (10) for measuring the erythrocyte sedimentation rate from a drop of blood taken from a finger prick, comprising a containment body (11), a reading chamber (20) located inside said containment body (11) and comprising a radiation emitter (40) and a corresponding radiation detector (50), and a fluidic channel (22), which extends from an inlet aperture (23), made through between said radiation emitter (40) and receiver (50), and configured to receive a blood sample consisting of a drop of a few microliters, characterized in that said fluidic channel (22) is substantially tubular in shape and is configured to stably receive a disposable capillary tube (30) suitable to contain said blood sample (S), and in that said manual device (10) is equipped with means (81, 90) for communicating and receiving data with external elements (91, E).

2. Manual device (10) as in claim 1, characterized in that said means for communicating and receiving data comprise an antenna (81) configured to communicate with external elements (E).

3. Manual device (10) as in claim 1, characterized in that said means for communicating and receiving data comprise a reader (90) configured to read a card (91) equipped with a readable element (92).

4. Manual device (10) as in any claim hereinbefore, characterized in that said containment body (11) has a parallelepiped shape and that said reading chamber (20) is attached inside said body (11) with said inlet aperture oriented perpendicularly to one of the walls (110A, 110B, 110C, 111A, 11 IB, 111C) of said containment body (11).

5. Manual device (10) as in any claim hereinbefore, characterized in that said reading chamber (20) is attached to a first circuit board (70) dedicated to carrying out the measurement of the erythrocyte sedimentation rate.

6. Manual device (10) as in claim 5, characterized in that it comprises, inside said body (11), a second circuit board (80) dedicated to the energy supply of said manual device (10) and to sending and receiving communications or data with external elements (E), and electrically connected to said first circuit board (70).

7. Manual device (10) as in claim 6, characterized in that said second circuit board (80) is also equipped with a communication block (82) which comprises a communication port configured to receive a corresponding cable or device withstorage memory.

8. Method for measuring the erythrocyte sedimentation rate, comprising a step of collecting a blood sample consisting of a drop taken from a finger prick and a step of analyzing said blood sample by means of a manual device (10) as in any claim hereinbefore.

9. Method as in claim 8, characterized in that said collection of the blood sample (S) occurs with a drop (G) of blood having a volume of a few microliters.

10. Method as in claim 9, characterized in that said collection of said blood sample (S) provides to place one end of a capillary tube (30) in contact with said drop (G) of blood.

11. Method as in any claim from 8 to 10, characterized in that said analysis step provides a stop and flow analysis in a microfluidic channel placed in contact with a drop (G) of blood.

12. Method as in claim 11, characterized in that said stop and flow analysis provides an outflow of the blood sample exclusively through capillary action and a stop of the outflow of the blood sample.

13. Method as in any claim from 8 to 12, characterized in that it provides to communicate the ESR results, by means of said communication means (81, 90), to an external element (91, E).

14. Kit for measuring the erythrocyte sedimentation rate, characterized in that it comprises a manual device (10) for measuring the erythrocyte sedimentation rate as in any claim from 1 to 7 and one or more capillary tubes (30) for collecting a blood sample.

15. Kit as in claim 14, characterized in that said one or more capillary tubes (30) are made of transparent material, such as glass or plastic.

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