WO2008072275A2

WO2008072275A2 - Telematic system for using diagnostic reagent strips and method for acquiring calibration data

Info

Publication number: WO2008072275A2
Application number: PCT/IT2007/000864
Authority: WO
Inventors: Francesca Genovese; Mariaconcetta Fiorino; Mariarita Costanza; Fano Amerigo De; Oronzo Cervelli; Oliviero Giusti
Original assignee: Biochemical Systems Internatonal Srl (20%)
Priority date: 2006-12-13
Filing date: 2007-12-11
Publication date: 2008-06-19
Also published as: EP2094153A2; WO2008072275A3; ITRM20060672A1

Abstract

The present invention relates to a telematic system (1) for using diagnostic reagent strips for analysing tissues/ said reactive diagnostic strips (8) being suitable to be read by an analysis device (17) within which a set of calibration reference values has been stored; said system (1) being characterised in that it comprises a central -unit (2) provided with data transceiving means; and one or more transceiving terminals,(4,..., 4n), each one of said terminals (4,..., 4n) being associated with a user and suitable to interface with said transceiving means of said central unit (2) and comprising an analysis device (17); and in that each one of said reactive diagnostic strips (8) has an associated reference code; and in that set of calibration reference values associated with said diagnostic strips (8), and with relevant identification code, is stored within said central unit (2). The present invention also relates to a method for acquiring a set of calibration reference data.

Description

TELEMATIC SYSTEM FOR USING DIAGNOSTIC REAGENT STRIPS AND METHOD FOR ACQUIRING CALIBRATION

DATA

The present invention relates to a telematic system for using diagnostic reagent strips and method for acquiring calibration data.

More specifically, the invention concerns a system permitting simplifying commercial distribution both of reactive diagnostic strips and calibration reference values necessary for their use, making at the same time more reliable diagnostic measurements that can be obtained.

As it is well known, at present importance of diagnosis of different medical parameters, such as value of glucose, cholesterol and triglyceride within blood is now recognised by scientific community as necessary for preventing different pathologies. Missing their control is one of the main reasons of increase of cardiovascular diseases.

Thanks to the advertising campaignes for prevention of chronical - degenerative diseases, an always more diffused attention is paid to prevention. This has generated an exponential increase of clinical exams, that are not always easily made for different reasons, such as need of keeping patients with the hospital, of making blood sampling, often traumatic for children, and the need of co-ordinating daily engagements with diagnostic needings, that often require delaying routine examinations.

Devices are presently available on the market, known as reflectometers (in vitro diagnostic devices), permitting measuring different medical parameters in a very practical way. However, said devices have remarkable limits.

A first problem of reflectometers is a consequence of distribution of reactive strips, usually sold packaged.

It is known that reactive strips to operate need one or more reference values (calibration values), necessary for obtaining exact measure of the detected parameter. Said value set is univocal for each batch of strips.

At present, each reactive strip box is provided with a microchip, within which the above reference value is stored. Modern reflectometers can measure different medical parameters, among which glucose, cholesterol or triglycerides. However, between the measurements of different parameters it is necessary replacing both reactive diagnostic strip and corresponding microchip. This procedure is very cumbersome. In fact, particularly for elderly people, the risk exists of loosing one of microchips between the different measurements of different parameters, thus making it unusable diagnostic strips corresponding to the lost microchip. Further, it is understood that logistic of said reactive strips is strongly conditioned by coupling of said microchips with the diagnostic strip packages, remarkably increasing managing costs.

A further technical problem in the diagnostic field is that concerning timely collection of acquired measurement data. In fact, above- mentioned reflectometers can detect only one measurement each time.

The user must write old measurements, so as to have a historical file of the same and permit to the doctor to have a suitable diagnostic situation.

It is evident that this procedure is expensive. At present, systems exist for telemedicine permitting to said devices connecting with data collection centres. Devices apt to make diagnostic analyses are reflectometers that in some cases can be integrated in, or can interface with, cellular phones, by which it is possible transmitting and receiving data fro/from an assistance centre. Thus, results of diagnostic detections are sent to said centre and possibly to doctors for their interpretation. However, said centres or telemedicine systems cannot control all the logistic and distribution chain of diagnostic strips, and therefore do not permit controlling quality of measurements taken by the users.

In view of the above, it is object of the present invention that of suggesting a system able permitting a logistic of distribution of diagnostic strips permitting saving costs and making easy diagnostic detections.

It is further object of the present invention that of permitting an easy managing of detected historical data.

It is a further object of the present invention that of suggesting a simple method for acquiring reference value set for making diagnostic measurements.

It is therefore specific object of the present invention a telematic system for using diagnostic reagent strips for analysing tissues, said reactive diagnostic strips being suitable to be read by an analysis device within which an set of calibration reference values has been stored, associated with said diagnostic strips, said analysis device being of the kind comprising a cavity receiving one or more of said diagnostic strips on which a tissue sample to be subjected to analyses has been placed by the user, said analysis device measuring one or more medical parameters; said system being characterised in that it comprises a central unit provided with data transceiving means; and one or more transceiving terminals, each one of said terminals being associated with a user and suitable to interface with said transceiving means of said central unit and comprising an analysis device; and in that each one of said reactive diagnostic strips has an associated reference code; and in that set of calibration reference values associated with said diagnostic strips, and with relevant identification code, is stored within said central unit; so that said user transmits said identification code to said central unit, by corresponding transceiving terminal, before using the diagnostic strip identified by the same and, then, said central unit transmits to the transceiving terminal of said user the calibration reference value set corresponding to the diagnostic strips associated with the received identification code, so as to permit to said analysis device making measurement of said medical parameters.

Always according to the invention, said reactive diagnostic strips are contained within packages, each package being indicated by an identification code valid for diagnostic strips contained therein; said central unit sending said calibration reference value set of diagnostic measurements that can be obtained with reactive diagnostic strips contained within the corresponding package to said transceiving terminal. Still according to the invention, said medical parameters can comprise glucose and/or cholesterol and/or triglycerides. Furthermore, according to the invention, connection channel between said central units and said transceiving terminals can be of the phone type, and particularly of the GSM and/or GPRS and/or UMTS type. Advantageously, according to the invention, said central unit can be connected with one or more users by the Internet. Preferably, according to the invention, said users comprise doctors, diagnostic centres, analyses laboratory, statistic centres, research centres, sanitary operators.

Always according to the invention, said central unit can detect possible exceeding of one or more pre-set thresholds by the measurements of said one or more parameters sending an aid message to at least one of said users. Still according to the invention, said analysis device can be integrated within the transceiving terminal.

Furthermore, according to the invention, said transceiving terminals can comprise a plurality of dedicated controls for controlling said analysis device.

Advantageously, according to the invention, said transceiving message can comprise a sliding panel, said sliding panel permitting access to said cavity of said at least a diagnostic strip.

Always according to the invention, said cavity can be placed under said transceiving terminal.

Advantageously, according to the invention, said analysis device can be integrated within a module, on the surface of which said cavity is obtained, said module being removably coupled with said transceiving terminal and suitable to permit housing a supply battery of said transceiving terminal.

Furthermore, according to the invention, said module can permit operative interfacing of said analysis device with said transceiving terminal.

Still according to the invention, said analysis device can be independent from said transceiving terminal and can be interfaced with the same.

Preferably, according to the invention, said analysis device can be a reflectometer.

Furthermore according to the invention, said transceiving terminals can comprise cellular phones.

Always according to the invention, said transceiving terminals can comprise an RFID (Radio Frequency Identification Device) reader, and in that an RFID tag is associated on said diagnostic strips, so that approaching said RFID tag to said RFID, said RFID reader acquires said stored identification code.

Still according to the invention, each RFID can be associated with a diagnostic strip package.

Preferably, according to the invention, said transceiving terminals can comprise a memory, a GSM/GPRS modem and a GPS receiver module, said GPS receiver being suitable to permit localisation of the corresponding user, transceiving terminal sending data about position of user corresponding to said central unit in case measurement of one analyse has a value lower or higher than set thresholds.

Furthermore, according to the invention, said system can comprise a processing unit connected with said central unit, suitable transferring to said central unit the calibration reference value set corresponding to the identification codes of diagnostic strips or of packages of diagnostic strips put on the market.

Advantageously, according to the invention, said diagnostic strips comprise a hydrophilic support, on which a reference hole is realised, and a membrane on which said tissue sample to be subjected to analyses can be placed, said tissue sliding by capillarity within a channel through which it reaches said analysis device.

It is further object of the present invention a method for acquiring an set of calibration reference data to be used within said telematic system, comprising the following steps:

(a) acquiring the identification code of the reactive diagnostic strips by a transceiving terminal;

(b) transmission of said identification code to said central unit;

(c) transmission of said set of calibration reference data relevant to said diagnostic strips identified by said identification code by the central unit; and

(d) reception of said set of calibration reference data by the transceiving terminal by the central unit.

Always according to the invention, said method can comprise the following step, before the above step (a):

- transferring by said processing unit to said central unit the set of calibration reference data corresponding to the identification codes of the diagnostic strips put on the market.

Still according to the invention, said transceiving terminals can comprise each one an alpha-numeric keyboard, and acquisition of identification code of reactive diagnostic strips during said step (a) occurs by key-stroking of the same by said keyboard.

Furthermore, according to the invention, each identification code can correspond to a package containing a plurality of reactive diagnostic strips.

Always according to the invention, acquisition of identification code of reactive diagnostic strips during said step (a) occurs by reading of the same code by said RFID reader approaching the RFID tag identifying the reactive diagnostic strips.

Still according to the invention, every RFID tag containing an identification code can be applied to a package containing a plurality of reactive diagnostic strips.

Furthermore, according to the invention, said transmission steps (b) and (c) and said reception step (d) can be realised by sending SMSs (Short Message System).

Still according to the invention, said transmission steps (b) and (c) and said reception step (d) can be realised by GPRS data transmission.

Advantageously, according to the invention, said transceiving terminal, after said step (d), can store said set of calibration reference data within said memory unit. The present invention will be now described, for illustrative but not limitative purposes, according to its preferred embodiments, with particular reference to the figures of the enclosed drawings, wherein: figure 1 shows a block diagram of the telematic system for using diagnostic reagent strips according to the invention; figure 2a shows a front view of a first embodiment of a transceiving terminal to be used in the system according to figure 1 ; figure 2b shows a lateral view of transceiving terminal according to figure 2a; figure 2c shows a module for housing an analysis device; figure 2d shows module of figure 2c coupled with a transceiving terminal to be used in the system of figure 1 ; figure 3a shows a front view of a second embodiment of a transceiving terminal to be used in the system according to figure 1 ; figure 3b shows a lateral view of transceiving terminal according to figure 3a; figure 4 shows a block diagram of the modular structure of a transceiving terminal according to the present invention; figure 5 shows a block diagram representing transceiving terminal in the initial configuration; figure 6 shows a block diagram representing transceiving terminal during procedure of sending identification code and acquisition of set of calibration reference data; figure 7 shows a block diagram for carrying out a diagnostic measurement and for sending the same to a processing and control central unit of the same; figure 8 shows a further block diagram representing transceiving terminal in procedure of sending identification code and acquisition of set of calibration reference data; figure 9 shows a perspective view of a reactive diagnostic strip; figure 10a shows a front view of the reactive diagnostic strip of figure 9; and figure 10b shows a lateral view of reactive diagnostic strip of figure 9.

Making reference to figure 1 , it is possible observing a technical block diagram of a telematic system 1 for using diagnostic strips according to the invention. Said system comprises a processing and control processing unit 2 provided with transceiving means (not shown in the figure) permitting its connection, by a transceiving channel 3, with a plurality of transceiving terminals 4' 4ⁿ suitable to transmission and reception of data through said channel 3. preferably, said transceiving terminals 4' 4ⁿ are cellular phones.

Transceiving channel 3 can be of every kind. In embodiments of the present invention, said transceiving channel 3 is a cellular phone channel, e.g. GSM, GPRS, UMTS channel.

Central unit 2 is connected to the Internet 5 through which a plurality of users 6', ... , 6ⁿ, such as doctors, diagnostic centres, analyses laboratory, statistic centres, search departments, different sanitary operators, can access to information contained within said central unit 2.

Transceiving terminals 4, ..., 4ⁿ comprise each an analysis device, particularly a reflectometer. By said device it is possible carrying out analyses of tissues, such as plasma, containing glucose, cholesterol, triglycerides and like.

Analyses is carried out by introduction of reactive diagnostic strips within a suitable cavity (not shown in the present figure), obtained in said analysis device, on said strips being beforehand deposited a droplet of blood or tissue to be subjected to analyses. Then, said device carries out an analyses making a processing of detections made by an set of calibration reference data, that must be available at the device before measurement.

In system 1 according to the invention, each diagnostic strip or each package of strips of the same batch is provided with an identification number or code to be sent beforehand to the central unit 2.

User that must carry out analysis transmits the identification code by cellular 4 to the central unit 2 that sends the set of calibration reference data to permit to the analysis device to make the measurement. Identification code can be sent in two different ways:

1) key-stroking code written on package (or on strip) and number of strips contained within the package, transmitting then it to the central unit 2. in this way, cellular 4 establishes a GPRS connection sending data. In case GPRS connection cannot be established, transfer occurs by SMS. Central unit 2 replies sending (by GPRS connection or by SMS) set of calibration reference data that is stored into memory of transceiving terminal 4 and that will be used for every detection employing a strip of the same package;

2) by employing an RFID (Radio Frequency Identification Device) reader, integrated in said transceiving terminal 4. An RFID tag is provided on every package of reactive strips, in said tag being stored said identification code to make then transmission of the same to the central unit 2.

User cellular phone 4 must be configured for sending data by GPRS channel, introducing parameters necessary to connection, such as APN of telephone provider of SIM employed, Internet provider (IP) of server receiving data and number of server cellular phone (prepared to receive SMS in case no GPRS covering exists).

Number of diagnostic strips contained within a package is counted, once introduced and sent the identification code. Thus, it is possible blocking operation of analysis device when a package of reactive strips is finished. Automatically, transceiving terminal 4 asks that operation of use of the first diagnostic strip of the new package is repeated. New set of calibration reference data will replace the previous one. Obviously, possibility will exist of changing the number of remaining strips that can be still used in case some of them are lost or fail. As it can be noted, system 1 also permits making a plurality of telemedicine services. Among them it is possible mentioning:

• remote monitoring of patients;

• memorisation of historical measurements; • processing of statistics about patient population in order to monitor different pathologies;

• analysis by thresholds, so that, if a value passes one or more set thresholds, it is possible activating pronto intervention or first aid measures. By system 1 shown in the present figure, it is possible carrying out a distribution and use mode of reactive diagnostic strips necessary for analyses permitting remarkable saving by an efficient system, permitting at the same time integrating and delivering telemedicine and tele-assistance services. Figures 2a and 2b show a first embodiment of a transceiving terminal 4, where analysis device or riflectometer is integrated in a cellular phone, having a cavity 7, that remains visible after opening of a sliding door 41 , and in which it is possible placing an analyses diagnostic strip 8.

It is observed that area 8' is present at the top of diagnostic strip 8, where it is possible placing tissue sample (e.g. blood) to be analysed.

Cellular phone 4 provides a plurality of special keys 9 with respect to standard phone apparatuses, for an easy managing of analysis device functions. Particularly, for every parameter that can be detected we have a different kind of reactive strips. On the basis of the parameter to be detected (glucose, cholesterol, triglycerides) it is necessary key-stroking corresponding key. Thus, device is ready to detect the chosen parameter. Anyway, functions can be easily managed by display 10. Figures 2c and 2d show a further embodiment of a transceiving terminal 4 wherein analysis device is integrated in a module 42, that can be removably coupled with the same terminal. Transceiving terminal 4 supply battery 43 is housed within said module 42. particularly, it is possible permitting operative interfacing between said analysis device and the printed board of transceiving terminal 4, e.g. by a serial gate (not shown in the figure) or by radio connection (e.g. blue tooth). From the figure it is also noted position of cavity 7 wherein a reactive diagnostic strip 8 can be introduced.

Figures 3a and 3b show a first embodiment of a transceiving terminal 4, wherein a diagnostic strip 8 is introduced within cavity T from below.

Figure 4 shows a block diagram of a cellular phone operating as transceiving terminal 4, wherein it is observed display 10, a

GSM/GPRS modem 11 , an alpha-numeric keyboard 12, a logic processing unit 13, a memory unit 14, a control module 15 and a GPS receiving module (16).

Cellular phone 4 further provides additional keys 9, for quick control of functions of transferring identification code and reception of set of calibration reference data, analysis device 17, in this case a reflectometer, a possible RFID reader 18, and a plurality of control modules 19', 19", 19"', for controlling set of calibration reference data, keys and localisation functions, respectively, that will be described in the following.

Figure 5 shows transceiving terminal 4, wherein starting configuration is carried out. Particularly: • a configuration procedure is set by said special keys 9;

• APN, static IP and server cellular phone number are keystroked by traditional numeric keyboard 12;

• display 10 shows configuration steps;

• key-stroked APN and IP are stored within transceiving terminal 4 memory 14.

Figure 6 shows block diagram representing transceiving terminal during procedure of sending identification code and acquisition of set of calibration reference data. Particularly,:

• self-diagnosis mode of transceiving terminal is selected by special keys 9;

• identification code of reactive strip 8 package is written by keyboard 12, if a new package is open;

• key-stroked identification code can be controlled on display 10; • key-stroked code is transmitted by special keys 9 to the central unit 2, through GPRS/GSM modem, by a remote connection with the Internet; • central unit 2 is connected with diagnostic strip 8 manufacturer by its own processing unit or server 20. This transfers set of calibration reference data corresponding to identification codes of diagnostic strip 8 packages put on the market;

• central unit 2 sends set of calibration reference data to the transceiving terminal 4. Transceiving terminal 4 stores said data within memory 14.

Figure 7 shows a block diagram wherein transceiving terminal 4 is employed for carrying out a diagnostic measurement and for sending the same to a processing and control central unit 2 of the same. Particularly:

• reflectometer 17 is activated;

• self-diagnosis mode and the kind of measure to be carried out are activated by special keys 9 (in this case, glucose, cholesterol, triglycerides analyses);

• diagnostic strip 8 is introduced within the cavity 7 or within hole 11 ;

• logic processing unit 13 detects from memory 14: (a) set of calibration reference data necessary for processing data detected from tissue sample on diagnostic strip 8 by reflectometer 17; and (b) server IP and APN of telephone provider and cellular phone number;

• logic processing unit 13 carries out calculation for obtaining measurement of selected diagnostic parameter;

• obtained information is displayed on display 10, stored within memory 14 and sent by GSM/GPRS modem 11 to central unit 2. As already said in the above, an embodiment of the present invention provides the solution wherein transceiving terminal 4 is provided with an RFID reader 18 and RFID tag is provided on each diagnostic strip 8 package. In this case, procedure for sending identification code occurs as follows: • RFID reader 18 is activated by special keys 9;

• simply approaching one of the diagnostic strips 8 package, the one indicated by reference number 21 in the figure, RFID reader 18 automatically acquires identification code stored within RFID tag;

• GSM/GPRS modem 11 transmits identification code of package 21 detected by central unit 2, sending the set of calibration reference data to the transceiving terminal 4, which is stored within memory 14.

Also in this case, central unit 2 is connected to processing unit 20 of diagnostic strip 8 manufacturer.

It must be taken into consideration that RFID tag is preferably of the passive kind, so as to be economic, not being necessary active elements, such as batteries.

As it can be observed, system 1 autonomously and automatically makes all calibration operations. This permits carrying out this delicate operations in a simplified way, being it only necessary approaching reactive strip 8 package 21 to the transceiving terminal 4. This is particularly suitable for elderly persons, generally not prone to use and follow complicated telematic procedures.

As described in the above, transceiving terminal 4 comprises a GPS receiving module 16, permitting detecting the user geographic position. Said transceiving terminal 4 can sand by said GPS receiving module 16 data concerning user position to said central unit 2 in case, for example, analyses measurement has a lower or higher value than a set threshold.

Reactive diagnostic strips 8 can be of any kind. A preferred embodiment is shown in figures 9, 10a and 10b.

Strips 8 shown have a hydrophilic support 22, on which a reference hole 23 is obtained, and a membrane 24, on which tissue sample (e.g. blood) can be placed. Tissue flows by capillarity within channel 25, by which it reaches reflectometer 17 for analysis. On the basis of the previous specification, it can be observed that basic feature of the present invention is the fact of permitting telematic transmission of technical data of the set of calibration reference data for carrying out diagnostic measurements.

Main advantages of the present invention are mainly a consequence of unifying the operation of two devices, such as cellular phone and reflectometer, or in vitro diagnostic device. An advantage of the present invention is that of easing remote monitoring of patients and at the same time optimising handling of reactive strips.

A further advantage of the invention is that of ensuring from remote position perfect operation of reflectometer and realising tele- assistance services on a single device and ensuring diffusion of prevention by self-diagnosis and increase of use of diagnosis devices.

Further advantages of the present invention are: elimination of manual calibration device between device and strip package, thus also eliminating relevant microchip, the function of which will be taken by transceiving terminal memory; the fact that integrating reflectometer into a cellular phone it is possible making very discrete its use in different cases; possibility of transmitting detected diagnosis data in real time; possibility for authorised medical centres, of preparing statistics about running of diagnostic data detected by one or more users within a set time period; improvement of reliability by a remote tele-assistance system; remote implementation of preventive tests; implementation within a single device of services such as lifesaving (tele-aid) with automatic localisation system (thanks to GPS module integrated within transceiving terminal or by localisation based on cell, using GSM network radio bridges); monitoring operation parameters of reflectometer integrated within device; and remote firmware updating.

The present invention has been described for illustrative but not limitative purposes, according to its preferred embodiments, but it is to be understood that modifications and/or changes can be introduced by those skilled in the art without departing from the relevant scope as defined in the enclosed claims.

Claims

1. Telematic system (1) for using diagnostic reagent strips for analysing tissues, said reactive diagnostic strips (8) being suitable to be read by an analysis device (17) within which an set of calibration reference values has been stored, associated with said diagnostic strips (8), said analysis device (17) being of the kind comprising a cavity (J, T) receiving one or more of said diagnostic strips (8) on which a tissue sample to be subjected to analyses has been placed by the user, said analyses (17) device measuring one or more medical parameters; said system (1) being characterised in that it comprises a central unit (2) provided with data transceiving means; and one or more transceiving terminals (4, ... , 4ⁿ), each one of said terminals (4, ..., 4ⁿ) being associated with a user and suitable to interface with said transceiving means of said central unit (2) and comprising an analysis device (17); and in that each one of said reactive diagnostic strips (8) has an associated reference code; and in that set of calibration reference values associated with said diagnostic strips (8), and with relevant identification code, is stored within said central unit (2); so that said user transmits said identification code to said central unit, by corresponding transceiving terminal (4), before using the diagnostic strip (8) identified by the same and, then, said central unit (2) transmits to the transceiving terminal (4) of said user the calibration reference value set corresponding to the diagnostic strips (8) associated with the received identification code, so as to permit to said analysis device (17) making measurement of said medical parameters.

2. System (1) according to claim 1 , characterised in that said reactive diagnostic strips (8) are contained within packages, each package being indicated by an identification code valid for diagnostic strips (8) contained therein; said central unit (2) sending said calibration reference value set of diagnostic measurements that can be obtained with reactive diagnostic strips (8) contained within the corresponding package to said transceiving terminal.

3. System (1) according to one of the preceding claims, characterised in that said medical parameters comprise glucose and/or cholesterol and/or triglycerides.

4. System (1) according to one of the preceding claims, characterised in that connection channel between said central unit (2) and said transceiving terminals (4 4ⁿ) is of the phone type.

5. System (1) according to claim 4, characterised in that said connection channel is of the GSM and/or GPRS and/or UMTS type.

6. System (1) according to one of the preceding claims, characterised in that said central unit is connected with one or more users (6, ..., 6ⁿ) by the Internet (5).

7. System (1) according to claim 6, characterised in that said users (6, ..., 6ⁿ) comprise doctors, diagnostic centres, analyses laboratory, statistic centres, research centres, sanitary operators.

8. System (1) according to one of the preceding claims 6 or 7, characterised in that said central unit (2) detects possible exceeding of one or more pre-set thresholds by the measurements of said one or more parameters sending an aid message to at least one of said users (6, ..., 6").

9. System (1) according to one of the preceding claims, characterised in that said analysis device (17) is integrated within the transceiving terminal (4).

10. System (1) according to claim 9, characterised in that said transceiving terminals (4) comprise a plurality of dedicated controls (9) for controlling said analysis device (17).

11. System (1) according to one of the preceding claims, characterised in that said transceiving message (4) can comprise a sliding panel, said sliding panel permitting access to said cavity (7) of said at least a diagnostic strip (8).

12. System (1) according to one of the preceding claims, characterised in that said cavity (7) is placed under said transceiving terminal (4).

13. System (1) according to one of the preceding claims, characterised in that said analysis device (17) is integrated within a module (42), on the surface of which said cavity (7, 7') is obtained, said module (42) being removably coupled with said transceiving terminal (4) and suitable to permit housing a supply battery of said transceiving terminal (4).

14. System (1) according to claim 13, characterised in that said module (42) permits operative interfacing of said analysis device (17) with said transceiving terminal (4).

15. System (1) according to one of the preceding claims 1 - 8, characterised in that said analysis device (17) is independent from said transceiving terminal (4) and is interfaced with the same.

16. System (1) according to one of the preceding claims, characterised in that said analysis device is a reflectometer (17).

17. System (1) according to one of the preceding claims, characterised in that said transceiving terminals can comprise cellular phones (4).

18. System (1) according to one of the preceding claims, characterised in that said transceiving terminals (4, ..., 4ⁿ) comprise an RFID (Radio Frequency Identification Device) reader (18), and in that an RFID tag is associated on said diagnostic strips (8), so that approaching said RFID tag to said RFID reader (18), said RFID reader (18) acquires said stored identification code.

19. System (1) according to claim 18, characterised in that each RFID tag is associated with a diagnostic strip (8) package.

20. System (1) according to one of the preceding claims, characterised in that said transceiving terminals (4, ..., 4ⁿ) comprise a memory (14).

21. System (1) according to one of the preceding claims, characterised in that said transceiving terminals (4, ... , 4ⁿ) comprise a GSM/GPRS modem (11).

22. System (1) according to one of the preceding claims, characterised in that said transceiving terminals (4 4ⁿ) comprise a

GPS receiver module (16), said GPS receiver being suitable to permit localisation of the corresponding user, transceiving terminal (4) sending data about position of user corresponding to said central unit (2) in case measurement of one analyse has a value lower or higher than set thresholds.

23. System (1) according to one of the preceding claims, characterised in that it comprises a processing unit (20) connected with said central unit (2), suitable transferring to said central unit (2) the calibration reference value set corresponding to the identification codes of diagnostic strips (8) or of packages of diagnostic strips (8) put on the market.

24. System (1) according to one of the preceding claims, characterised in that said diagnostic strips (8) comprise a hydrophilic support (22), on which a reference hole (23) is realised, and a membrane (24) on which said tissue sample to be subjected to analyses can be placed, said tissue sliding by capillarity within a channel (25) through which it reaches said analysis device (17).

25. Method for acquiring an set of calibration reference data to be used within said telematic system (1) as defined in claims 1 - 24, comprising the following steps:

(a) acquiring the identification code of the reactive diagnostic strips (8) by a transceiving terminal (4);

(b) transmission of said identification code to said central unit (2);

(c) transmission of said set of calibration reference data relevant to said diagnostic strips (8) identified by said identification code by the central unit (2); and

(d) reception of said set of calibration reference data by the transceiving terminal (4) by the central unit (2).

26. Method according to claim 25, characterised in that it comprises the following step, before the above step (a):

- transferring by said processing unit (20) to said central unit (2) the set of calibration reference data corresponding to the identification codes of the diagnostic strips (8) put on the market.

27. Method according to one of the preceding claims 25 or 26, characterised in that said transceiving terminals (4, ..., 4ⁿ) comprise each one an alpha-numeric keyboard (12), and acquisition of identification code of reactive diagnostic strips (8) during said step (a) occurs by key-stroking of the same by said keyboard (12).

28. Method according to claim 27, characterised in that each identification code can correspond to a package containing a plurality of reactive diagnostic strips (8).

29. Method according to one of the preceding claims 25 or 26, characterised in that acquisition of identification code of reactive diagnostic strips (8) during said step (a) occurs by reading of the same code by said RFID reader approaching the RFID tag identifying the reactive diagnostic strips (8).

30. Method according to claim 29, characterised in that every RFID tag containing an identification code can be applied to a package containing a plurality of reactive diagnostic strips (8).

31. Method according to one of the preceding claims 25 - 30, characterised in that said transmission steps (b) and (c) and said reception step (d) are realised by sending SMSs (Short Message System).

32. Method according to one of the preceding claims 25 - 31 , characterised in that said transmission steps (b) and (c) and said reception step (d) are realised by GPRS data transmission.

33. Method according to one of the preceding claims 25 - 32, characterised in that said transceiving terminal (4), after said step (d), stores said set of calibration reference data within said memory unit (14).

34. System (1) and method according to each one of the preceding claims, substantially as illustrated and described.