The analytic manipulation of biological, protein or metabolic samples historically exhibits an inherent technical constraint due to the high specificity between the analyte and the method for singling it out, generally entailing the carrying out of a plurality of analytical procedures and the implementation of the relative analytical procedures in different and large-sized equipments, i. e. in laboratory bench equipments.

Moreover, such procedures and the interpretation of the result require a different expertise for each analysis carried out, generating the need of skilled technical operators.

All this leads to the centralized architecture typical of the molecular diagnostics laboratories, e. g. biomedical, agricultural or forensic, anyhow equipped with instruments and capabilities dedicated to individual analyses or to families of alike analyses, therefore capable of processing a high number of samples in parallel.

From this architecture there ensues the thematic specialization of the laboratories, with the entailed concentration of samples from vast geographic areas and the occurrence of the related logistic problems.

In this regard, it has to be pointed out that, while on the one hand DNA analysis based on polymerase chain reaction (in short, PCR) was expected to revolutionize this context, on the other hand the most recent evolution of the instruments, though progressing to a greater lightness and simplicity, did not actually allow to overcome the barrier set by centralized laboratory organization.

Incidentally, the PCR (polymerase chain reaction) as it is known, is a technique allowing to amplify a certain DNA sequence up to millions of times, thereby making it easily detectable and analyzable. This is particularly useful, for instance, when the sequence belongs to a gene implicated in a certain pathology or it represents a foreign gene as in the case of viral infections of genetically modified organisms. The PCR makes use of a thermostable DNA polymerase (Taq) and of complementary

synthetic oligonucleotides (primers) at the 5'and 3'ends of the region of interest.

Moreover, MgCI2 and triphosphate deoxyribonucleotides are required, as well as an instrument capable of performing a cyclic reaction at three different temperature levels (95°C, 50-60°C, 72°C) known to the art as thermocycler.

Over the years the application has been improved introducing ever more reliable and fast instruments, coming to the conceivment and the use of robotized systems capable of assembling and controlling various parallel PCR reactions, by their connection interface to thermocyclers.

In particular, the coupling of this biochemical reaction having polychrome labelling systems to fluorochromes, led to the employ of instruments capable of exciting and detecting the labelled amplification products, thereby increasing the system sensitivity and productivity. Such instruments are the DNA sequencers, capable of performing sequence analysis according to Sanger method from DNA fragments amplified and labelled by PCR. A further development saw the employ of these analyzing instruments in the dimensional analysis of PCR products labelled at their termini with different fluorochromes.

However, these advancements failed to substantially change the abovedescribed laboratory centralization context. This inevitably barred hundreds of viable specialized applications.

In fact, the viable applications of PCR-based DNA analysis are several and extremely differentiated, both in biomedical (forensics, genetic, oncological, viral diagnostics) and in agricultural-zootechnical fields. E. g. , the joint use of the PCR and of sequencers in the study of hypervariable human DNA regions (the 'microsatellites') allows the absolute individual identification, the"DNA fingerprinting" deemed as legal evidence. Alike investigations are made possible by coupling PCR to sequence electrophoresis for the study of mutations correlated to oncologic and genetic pathologies, e. g. complex pathologies like tumors linked to BRCA1 and 2 gene mutations, or single-gene pathologies like cystic fibrosis, fragile X syndrome and Huntington's disease. Moreover, the pharmacological treatment of several illnesses like AIDS can be monitored by the POL and RT gene sequence of the virus whose variability influences the resistance to the various drugs. Hence, the occurrence of drug resistance can be typed, making a therapy modification viable.

DNA investigation by detection and analysis of specific microsatellites proved of utmost importance and usefulness in the agricultural and zootechnical field as well.

E. g. , the former may be fundamental for reconstructing the provenance and the

original strain of vegetables, meat and fish, in order to prevent food adulterations.

Despite constant technical advancements, the abovedescribed differentiation has made specific analyses costly and difficult, requiring specific laboratories that are scarcely available, and anyhow prevented the introduction of a marked flexibility in the genetic investigations.

The technical problem underlying the present invention is to provide an integrated device for carrying out a genetic investigation allowing to overcome the drawbacks mentioned with reference to the known art, as well as an equipment such as to effectively carry out the investigation and the related reading of the results.

Such a problem is solved by an integrated device for carrying out a genetic investigation, comprising: * an amplification chamber, dedicated to the carrying out of PCR on a genetic sample, containing reactants for a specific investigation; * an electrophoretic equipment having at least one electrophoresis chamber, electrodes, means for the electrophoretic separation of the amplification products, a reading window; and * an identification code of said specific investigation.

The main advantage of the integrated device for carrying out a genetic investigation according to the present invention lies in allowing any kind of specific analysis preset in the device, requiring specific reactants, by the employ of a simplified examining and reading equipment, not requiring the use of laboratory equipments.

This is made possible by the implementation of an investigation device, substantially yet not exclusively disposable, incorporating the reactants and the instruments required for the practical performance of any specific and predefined genetic analysis.

It is understood that such a device requires a dedicated examining and reading equipment, capable of carrying out analyses specific to each device merely providing the support members, the timed heating for the temperature cycles for the PCR amplification, the applying of suitable electric fields for the electrophoretic separation of the products, the detectors at the suitable wavelengths for analyte detection, etc. , and of resending the results obtained to a memory storage system.

The identification code provides to the equipment at least the information concerning the specific investigation to be carried out, allowing the equipment to

select a correct operation cycle.

In an exemplary device object of the present invention, the identification code is provided on a memory storage medium onto which there are recorded the instructions for making the equipment carry out the steps required for the analysis.

According to the same inventive concept, the present invention relates to an examining and reading equipment comprising: * a seat for housing an integrated device for carrying out a genetic investigation, comprising: an amplification chamber, dedicated to the carrying out of PCR of a genetic sample, containing reactants for a specific investigation; an electrophoretic equipment having at least one electrophoresis chamber, electrodes, means for the electrophoretic separation of the amplification products, a reading window; and an identification code of said specific investigation; * means for reading said identification code; * thermal means for a specific thermocycling of said genetic sample ; * means for selectively applying a voltage to the electrodes of said integrated device; * means for reading electrophoretic analysis results at said reading window; * means for displaying and/or storing said results.

Advantageously, the equipment could have a microprocessor system capable of carrying out the instructions relative to a specific analysis according to the reading of said identification code.

Said instructions could come from an instruction library external to the equipment or incorporated in a memory of the equipment, or even from the content of a memory associated to the integrated device.

The results of the analysis could be displayed and/or stored by suitable instruments, of the equipment or remote and linked thereto by any telecommunication system.

In a version of the invention, the results will be stored on a memory storage medium integral to the integrated device, which therefore could preserve the genetic sample employed and the results of the genetic investigation, making it an effective probative instrument.

Moreover, it is understood that the adoption of specific standards allows an

equipment as abovedefined to read solely, and with an infinite repeatability, the results of an investigation carried out on a different equipment.

In the light of the above, while a classic analysis, carried out on DNA or not, is always the result of a sort of procedure, i. e. a serial arrangement of machine and operator activities, the concept disclosed and defined hereto revolutionizes also that of analysis, making the latter resemble an integrated and basically automated process, yet concomitantly equipped with intrinsic quality control and testing instruments.

This system enables a single machine to process a potentially endless number of applicative devices, each preset for a specific analytic need. The modular architecture of the system further enhances its flexibility that may easily adapt to devices having more advanced technological contrivances like the preprocessing of the sample by restriction enzymes or by the hybridation of tracer-labelled probes, or biosensor-equipped devices, etc. Obviously, it will be the specific exam needed that will suggest the adoption of this or that analytic module combination in the implementation of the specific device, allowing to make low engineering cost applications, therefore eliminating the economic barrier to the development of niche solutions, whose numbers do not justify the setting up of a traditional analytical instrument.

The present invention will hereinafter be described according to a preferred embodiment thereof, given by way of example and without limitative purposes, with reference to the annexed drawings, wherein: * Figure 1 is a schematic plan view of a integrated device for carrying out un genetic investigation according to the invention; * Figure 2 is a partially sectional perspective view of the device of Figure 1; * Figure 3 schematically depicts an examining and reading equipment provided to the device of Figure 1; and * Figure 4 depicts an operation diagram of the equipment of Figure 3.

With reference to the figures, an integrated device for carrying out a genetic investigation is generally indicated by 1.

Such a device 1 is formed in a device body 2 substantially possessing a card shape, i. e. a laminar and rectangular shape, and containing thereinside the components required for a specific analysis.

Such components, which will be detailed hereinafter, are one amplification chamber 3, dedicated to the carrying out of the PCR amplification of a genetic sample (DNA), at least one dilution chamber, in the embodiment there being a pair (4a and 4b) thereof, electrode pairs, a capillary duct 5, i. e. means for the electrophoretic separation of the amplification products, a window 6 for detecting the fluorescence of the latter, and an identification code 7 of the specific investigation or analysis.

As it will be made apparent hereinafter, the latter member makes the device capable of being correctly driven by an examining and reading equipment.

With reference now to the detailed description of the device 1, it comprises means for injecting a sample thereinside.

Said injecting means comprises an inlet duct 8 that is equipped with a sealing member, in the present example a septum 9, preferably made of an inert material such as a silicone or fluorosiliconic rubber or other alike material, serving to seal the connection between the subsequent amplification chamber 3, where the so-called thermocycling takes place, and the outside.

In the case the amplification chamber 3 is envisaged to be under vacuum, said sealing member serves to keep a negative pressure state inside of the amplification chamber 3.

Instead, the inlet duct 8 is wide enough to serve as guide of the member that is used to let in the genetic sample to be analyzed, e. g. a syringe needle. In particular, a needle or another pointed introduction member may perforate the septum 9 and let, also by virtue of the internal negative pressure, the sample into the amplification chamber 3.

In this case, advantageously the septum 9 is made of a soft and flexible material that is penetrated by the pointed introduction member and that elastically recloses once the latter is extracted.

However, it is understood that said sealing member, in order to adjust to different inletting methods like a dropper or any other transferring system, may comprise a removable cap, a small cover or other sealing system.

The inlet duct 8 is integrated in the device body 2, e. g. as it is made of a wafer in a plastics thermoformable material like polypropylene, or injection-molded and then welded, e. g. with a high-frequency methodology.

Other viable materials are glass, polyethylene, polyethylene terephthalate, inert rubbers, and noble metal, non-noble metal surface-treated with plasma deposition

techniques and the like.

The inlet duct 8 and the device body 2 may be integrated therebetween by mechanical coupling or by gluing with inert adhesive.

At the septum 9 and at the amplification chamber 3, the device 1 comprises a first electric contact 10 intended to be used as electrode. In this embodiment, such a contact 10 comprises a foil held between the two abovementioned parts, so as to be introduced in the amplification chamber 3 downstream of the sealing member.

The amplification chamber 3, seat of said thermocycling, has an internal space having a suitable volume, in the order of a few cubic millimeters, preferably of 10 mm3, with walls made of a heat-resistant material as glass or a synthetic polymer, e. g. polypropylene, with a substantially cylindrical geometry and closed at the respective ends: at the one end by the septum 9 and at the other end by a first valve 11.

Said chamber 3 is the container destined to the carrying out of the Polymerase Chain Reaction (PCR) by thermocycling.

This stage of the process takes place according to a scheme envisaging three steps: i) denaturing, consisting in the thermal separation at 92-96°C of the two DNA strands; ii) coupling, in which, cooling the mixture at a predetermined temperature (55- 60°C), to two short triggering sequences, the primers, the specific coupling to each of the previously separated strands is allowed ; and iii) extending, causing DNA duplication by the elongation reaction of each primer enacted by the enzyme DNA polymerase that acts at 70-72°C, using each of the original strands as primer.

The cyclic repetition of the three steps described produces the amplification of up to millions of copies of the desired sequence, which becomes easily analyzable.

Therefore, the amplification chamber contains a reaction buffer solution, the enzyme polymerase TAQ, a mixture of triphosphate nucleotides (dNTPs), and MgCI2 Moreover, it contains the so-called primers, synthetic oligonucleotides specifically designed for the sequence to be amplified.

What is listed as content of the amplification chamber 3 generally constitutes the

reactants related to the specific investigation to which the integrated device is destined.

In the prearranged device, the specific reactants are preferably lyophilized thereinside and are made soluble by the mixture that is injected along with the sample.

The chamber 3, as to the materials and the coupling onto the body 2, does not diverge from the inlet duct 8.

The chamber 3 is coupled to the subsequent component by a first connecting duct 12 secured to the chamber 3 by a miniaturized seal or with glue or even by mere mechanical retention performed by the device structure. Needwise, sealing members, like e. g. silicone O-ring and the like, may be provided. From the construction viewpoint, the above may be applied also to other parts of the device.

Such first connecting duct 12 contains said first valve 11. This valve carries out the fundamental role of sealing off the amplification chamber 3 from the rest of the device 1. In particular, it allows to keep a negative pressure state required for the loading of the chamber 3 and for the lyophilizing of its content. Such a valve may be of simplified structure and its opening may be rupture-induced, allowing the passing to the subsequent steps of the mixture resulting from the amplification, obtained at the end of the thermocycling reaction.

Said first valve 11, in the present embodiment, is made of a clip that, at an early stage, keeps pressed the connecting duct 12 that for this purpose is made of a flexible material, i. e. strainable by pressing and capable of returning to an opened configuration when the pressing is over.

Said clip, consequent to a suitable mechanic command, is disconnected, thereby opening the duct 12. Such a clip may be made of steel-like metal or of plastics.

An alternative valve comprises a ball, made e. g. of glass, serving as duct interrupter and that is broken up or moved into a recess adjacent to the duct by effect of a mechanic action, thereby clearing the duct 12.

Along the mixture path, additionally to the first valve 11, the device 1 comprises a dilution chamber 13 and, subsequently, an electrophoretic equipment, preset for electrophoretic analysis, equipped with electrodes, means for the electrophoretic separation of the amplification products and window 6 for analyzing the separated products. Dilution chamber 13 and electrophoretic equipment are partitioned by a second valve 15, analogous to the first valve and activated when dilution of the

mixture is complete.

The dilution chamber 13 has the purpose of diluting the content of the amplification reaction mixture in order to make it compatible, needwise, to the subsequent electrophoretic analysis.

Hence, in the dilution chamber 13 on the one hand salts are diluted, thereby reducing the electric conductivity of the solution, on the other hand an optional introduction of DNA-denaturants is made possible, essential to carry out electrophoreses aimed at analyzing the individual strands.

The dilution chamber 13 is electrically connected to said first electric contact 10 serving as negative electrode (cathode), allowing the electroapplication of the sample to the electrophoresis apparatus.

As in the amplification chamber 3, which may be referred to for the materials and the structure couplings, it is possible to heat the dilution chamber 13 so as to denature the sample and to allow the subsequent electrophoretic run under denaturing conditions.

Therefore, the dilution chamber may contain non-denaturing diluent, denaturing diluent, in-diluent fluorescent labeller, in-diluent fluorescent molecular weight labeller.

The dilution chamber is connected to the subsequent electrophoretic equipment by a second connecting duct 14 equipped with said second valve 15, components analogous to the respective first connecting duct 12 and first valve 11.

Hence, the electrophoretic equipment comprises a first electrophoresis chamber 4a located downstream of said second valve 15 and connected to a second electric contact 17 that is positioned adjacent to said first electric contact 10, both being intended to be used as cathode. As the first electrophoresis chamber 4a lies inside of the body 2, far from the edge at which the electrode is positioned, the chamber 4a is connected to the latter by a conductor 18.

A second electrophoresis chamber 4b is positioned near to a third electric contact 16 intended to be used as anode, said electrophoresis chambers 4a, 4b being connected by the capillary duct 5 that serves as means for the electrophoretic separation.

Each chamber serves as anode and cathode compartment, respectively, of the electrophoretic cell and is required for the migration of the products in an electric field.

The electric field, or merely the voltage between said electrodes, is applied first between the first electric contact 10 and the third electric contact 16, determining a conducting path comprising the amplification chamber 3, the dilution chamber 13 and the electrophoretic equipment branch downstream of the first electrophoresis chamber 4a.

This voltage effectively determines the transfer of the diluted mixture from the dilution chamber 13 to the electrophoretic equipment.

Subsequently, the voltage is applied between the second electric contact 17 and the third contact 16, allowing to carry out the actual electrophoresis.

For this purpose, in said electrophoresis chambers there is contained a buffer solution, the so-called running buffer, which may vary according to the electrophoresis carried out. In fact, upon deviating, after a suitable time, the application of the voltage from the dilution chamber 13 (first electric contact 10) to the anodic electrophoresis chamber 4a (second electric contact 17) a controlled transfer is attained in the electrophoretic capillary duct 5 not only of the sample but also of said buffer solution of the first electrophoresis chamber 4a.

The solutions employed are of conventional type for electrophoresis, TBE, TAE, or others comprising denaturants, e. g. formamide, when required.

The means for the electrophoretic separation comprises said capillary duct 5, a cylinder-shaped hollow glass capillary having a length ranging from 20 to 50 cm with a 50-100 um internal diameter. Said capillary is filled with a buffered aqueous solution comprising inert polymer substances. Near to the capillary end there lies an optical window 6 through which absorption and fluorescence signals may be recorded.

Incidentally, the electrophoretic analysis is based on the separation, depending on the molecular sizes, of ionic substances in a solution migrated inside of the capillary by virtue of a strong electric field applied at the ends thereof. In fact, the texture of the inert polymer inside the capillary determines a slowing down of the different DNA fragments that is all the more marked the greater is the molecular size of the species in motion. The sequential passage of the various specimens of DNA molecules in front of the optical window allows their identification (detection) and quantification by absorbance or fluorescence detection devices, depending on the analysis.

The polymers employed are linear-chain hydrophilic polymers having several polar

groups like e. g. the derivatives of acrylamide (e. g., NN-dimethyl polyacrylamide), of cellulose (e. g., hydroxyethylcellulose), the polyethylene glycol, the polyethylene oxide, the polyvinylpyrrolidone or even other commercially available ones.

The reading window 6 of the optical signals (fluorescent or from absorption) is located near to the end portion of the electrophoresis capillary duct 5. The former has the task of allowing the lighting up of the capillary and the optical signal observation for absorption detection. The window may be a mere opening, or it may be made of a see-through material like glass or plastics, also in order to mechanically protect the capillary.

In order to abate optical disturbance phenomena, two plates may be glued therebetween and to the capillary with a see-through adhesive or silicon grease.

Another alternative is that of glass or of a mere empty window crossed by the sole capillary. Such window 6 may optionally incorporate a small lens focused on the capillary, made integral to the window or constituting the latter.

Concerning the geometry of the device body 2, which houses amplification and dilution chambers and the entire electrophoretic equipment, it foresees a flattened rectangular shape, preferably having the dimensions of an ordinary credit card, with the top and bottom faces optionally shaped so as to contain the constituents of the entire analysis duct.

A suitable material is a polypropylene or an equivalent material, with inserts of various materials, e. g. glass, plastics, metal as copper and/or gold plating for the electric contacts.

However, it is understood that the abovementioned shape should not be construed as limitative. It may be replaced by an equivalent shape providing analogous performances in handiness and insertion in an adequate seat of an examining and reading equipment.

Other compatible shapes could be the typical ones of a floppy disc, of a test tube or of a pen.

Besides the abovedescribed components and the identification code, which could be a mere bar code or a permanent magnetic track, the device could comprise a microprocessor provided with appropriate memory, e. g. of the type printed directly onto the foil forming the body 2 of the device 1.

The memory-equipped microprocessor, not shown in the figures, could hold for a long time data as well as execution programs, or be read and/or written by an

external device, optionally for the recording of the data resulting from the preset specific genetic investigation. The microprocessor may comprise said identification code.

Hence, the device 1 may operate in the following modes: a) mere reading (passive) The device contains only the identification data related thereto, and optionally other information that will be read and used by the examining and reading equipment. b) advanced reading (active) The device contains data readable by the examining and reading equipment depending on conditions checked by the former. c) reading/writing The device is readable subsequently writable (at its memory) for holding e. g. the data related to the measuring carried out and to the relative information identifying instrument, data, site, operator, size identification, etc. The presence of a microprocessor may facilitate the use of ciphering techniques making what has been written readable only by a specific enabled reader, e. g. the one that has carried out the writing, or by whom possesses all the codes from which the ciphering takes place. This may be useful in applications having a marked legal relevance. d) storing The memory area of the device can be used to keep track of the individual measurements of a complex experiment. After the normal measuring steps carried out with conventional devices, the measuring-related data may be saved by inserting the storing device.

Therefore, it is understood that the device may be preset for any genetic investigation with the utmost flexibility, so much so that personalized settings based on users'demand may be envisaged. Lastly, the device, by virtue of its flexibility related to logical properties, may unceasingly be renewed, admitting even radical modifications deriving from the introduction of innovative analytical technologies.

The use of the abovedescribed device will be made apparent in the following description of an examining and reading equipment, generally indicated by 100, and of the operation thereof, given with reference to figures 3 and 4.

In the equipment 100, the functionalities related to and required for the correct

execution of the measuring, and those related to the treatment of the results, are delegated to a microprocessor-or microcontroller-based system.

The central unit (CPU) is based on a microcontroller system 101. At power up, the CPU executes a series of diagnostic checks, by which it identifies the effective configuration of the system and the correct operation. The quantity of available memory and its correct operation is checked with reading and writing checks. Then, provided everything is working smoothly, a supervisor software routine enters execution and continues to be cyclically executed until power down. At each cycle a series of logical conditions is checked, and upon checking each of them, a software portion suitable for managing the occurrence is sent for execution. When unforeseen conditions occur, an error notifying and managing procedure will be recalled.

The CPU could be equipped with a 32-bit bus, in order to facilitate the dialog with the applications currently employed in the most widespread Operation Systems and not to incur in practical limitations in the availability of physical resources to the system. Moreover, preferably the CPU is capable of dynamically varying the operation frequency in order to curb power consumptions.

The CPU unit presides, via suitable software, over the needs of the following functions: self-diagnostics ; use mode checking/changing; operative conditions and correctness (alarms) checking, recording, measuring; system component and/or user registry identification; compatibility checking; dialog with the various subsystems connected to the instrument; dialog (reading/writing) ; executing measure thermocycling program; TC thermostatization as programmed; dialog with Operator; measure result reading/filtering/displaying ; measure result saving; and dialog with NODO and (indirectly) with HOST levels.

A controller 102, such as to avail itself of at least 16 interrupting routines in hierarchical order, will be dedicated to detect and to manage events like : reaching of a temperature; attemperation; timer expiry; and deviation from the foreseen operative conditions.

The stabilization of the temperature of the amplification chamber 3 in the holding steps and the programmed attemperation to a higher or lower new temperature could be referred to the CPU. This option entails the advantage of easily adjusting the control logic to the heat exchange coefficients of the materials used and to the system heating and cooling rate that will be influenced by the environmental conditions.

A clock 103, equipped with a 16-bit counter, is capable of correctly timing the thermocycling cycle and to hold the date for managing the other processes.

A memory 104 has the task of storing the programs, the data and the rules related to the execution of the measuring, and all the measuring-related information and results. Likewise, all intermediate data of each step of each processing will be stored in memory.

The CPU microcontroller/measuring system interaction will take place via an Input/Output module 105, which will enable the logic component to interact with physical devices to control actuators that will be described hereinafter, light signaling, acoustic signalers, display, or non-stationary components. Via the)/0 module 105 the state of push buttons, keyboards, switches, etc. may be detected.

The module 105 should be equipped with an adequate number of channels, preferably no less than 48.

A set of eight A/D converters 106, having an 8-bit resolution (1/256 fraction accuracy) with a rate of at least 1000 samples/second, will be dedicated to converting the analog quantities, and in particular to: measuring the environmental temperature and the temperatures related to the operating conditions required for the correct operation of the device 1; measuring the signal outputted by the device- related reading system; and controlling the state of the power-supplying devices.

There could be employed two channels for controlling the temperature of two different zones of the device, one for reading the room temperature, one for monitoring the power-supplying devices, four dedicated to the measuring of the signal outputted from the device-related reading system.

A digital bus 107 constitutes the set of the connections carrying all the signals required for the operation of CPU 101.

The CPU 101 is equipped with at least one serial connection 108 according to the standard RS232 for the easy connection to a Personal Computer. A further module 109 may be connected to the BUS to host devices for the most widespread connections (USB, Firewire, Irda), a standard Ethernet port and a wireless phone connection. On the same module there may be available integrated resources allowing the use of an Unix-like operative system having an embedded-type i. e. memory-resident microkernel,.

Through the connection with other devices, there will be made viable: the on- instrument loading of the operative parameters for carrying out measurements; the

firmware updating and/or modifying; the transferring of the measuring result to another system; the system piloting by an external processor (use as measuring peripheral unit), the use as network node for connecting to networks or systems distributed according to standard protocols, with connecting options identical to that of an office machine.

Concerning the physical structure, the equipment 100 comprises a casing 110 housing all the components and a slot 111 for the insertion of the device 1.

Said slot 111 forms a seat for housing an integrated device as abovedescribed and hence it will assume the shape of a normal card reader or of a floppy disc reader, etc.

In particular, the equipment, it being contrived for a portable use, contains rechargeable batteries (not shown) internally or in a separate container. The former may also be used as a directly network-supplied stationary unit.

A second power-supplying module will allow the direct power-feeding from a motor vehicle, etc. Thus, as in portable computers, there may be provided a small power supply integral to the power cable so that the equipment is directly supplied with DC power.

The next components are faced internally to the slot to interact with the device.

Hence, the equipment 1 comprises thermal means for carrying out a thermocycling, located inside of the slot 111 so as to correspond to said amplification chamber 3 and optionally also to said dilution chamber 13.

Said thermal means comprises a heater 112 having a low thermal inertia, operating in combination with the amplification chamber 3 and that may be of various types: a) induction-type, i. e. using the electric field to transfer energy to the thermocycling chamber serving as dielectric (between the two condenser members) -the control of the electric field may take place varying the field frequency or intensity; b) with microwave generator; c) operating by contact, i. e. with a heat generator, e. g. with resistances, placed in the immediate vicinities of the amplification chamber that transfers heat via a conductive body; d) High thermal capacity fluid-circulating microhydraulic system that opens a vesicle on the amplification chamber and more than one reservoir; each

thereof at controlled temperature and corresponding to the different temperatures needed and required for the PCR cycle. e) Along with said heater 112, said thermal means will comprise a cooler 113 adoptable according to different solutions: f) Forced-air jet or Peltier cell contact cooling systems, or others like a refrigeration microcell, in particular for the heaters a), b) and c); g) By the microhydraulic system described above at d). h) For each of the abovelisted thermal means, the equipment has temperature monitoring means: i) temperature sensor (e. g. of commercial type) located near to the amplification chamber; in this case, a proportional rather than a direct reading is carried out, allowing to deduce the actual temperature of the chamber-see a), b) and c); j) temperature sensor located inside the device 1; k) sensor located inside each of the different-temperature reservoirs-see d).

The equipment 100 further comprises a voltage generator, not shown, consisting of a module that may be located inside the equipment or in a separate container. It supplies high voltage in DC that may be fixed or adjustable. Typically, the output voltage may range from 2000 to 8000 V. The output voltage of the power supply may be adjusted manually or by internal control programmable via a software. The unit may be protected at the output from short circuit and undesired discharges.

There may be provided the option of displaying the voltage actually supplied.

Moreover, the equipment 100 comprises electric outlets for supplying voltage at said electric contacts 9,16 and 17.

Said outlets and said generator substantially constitute means for selectively applying a voltage to the electrodes of said integrated device.

The electric outlets for the electrophoresis, 115,116 and 117 respectively, may be spring terminals, e. g. shaped as a leaf, bracket/lamina, spiral, etc. traditionally used for network power-supplying. The outlets should be sufficiently insulated, so as to ensure safety of use. As a further member for protecting from accidental discharges, the power supply unit may be equipped with a mechanic device that disconnects the power-supplying when the cover is opened, and/or with an electronic control that in the absence of the device inhibits the power-supplying.

The equipment comprises valve opening means 118,119 for the valves 12,15 requiring to be opened at a specific time of the investigation cycle.

Such means requires a mechanical actuation. In order to curb the energy consumption of this mechanism, such means foresees a system of springs that are compressed during the closing of the cover for introduction in the slot 111. Thus, only a small force shall have to be applied in order to release the spring that will cause the removal of the clip of the corresponding valve.

The equipment 100 comprises means for reading the electrophoretic analysis results, to be activated at the reading window 6 of the device 1.

Such reading means comprises e. g. an optical system 120 for detecting fluorescence signals, capable of carrying out three different tasks: 1. lighting up the sample in order to excite fluorescence; 2. the optics collects the fluorescence signal and sends it to the detecting system; and 3. the detecting system observes the spectral composition of the fluorescence optical signal so as to recognize the labelling chromophores.

The design philosophy aims at attaining a cost-effective and portable system. For this purpose, a viable solution comprises the use of a device based on LEDs and silicon multielement photodetectors.

The optical detecting system may be subdivided into the following main components: source; optical system; detector; and power-supplying and amplifying electronics.

The source has the task of lighting up the sample fraction at the window 6 with a light radiation having a suitable intensity and a wavelength apt to excite one or more chromophores. Plural sources may be used as well, optionally also concomitantly.

The optical system has the task of concentrating the source-emitted light onto the capillary at the reading window 6.

The detector has the task of observing the end portion of the capillary, of recognizing the instant of fluorescent molecule crossing and of giving information on the spectral distribution of the fluorescence light. A delay in the crossing from the run start yields information on the molecule size; the fluorescence spectrum allows the recognition of the different labeling chromophores.

An electronic device powers the source (or the sources) and optionally modulates

the intensities. Moreover, the electronic system amplifies the signals from the photodetectors. The outputted signals are sent to a digital analog converter for the acquisition and the subsequent processing by the analysis software.

The abovedescribed result reading means may be connected to any means for displaying and/or storing, integrated to the equipment as well as belonging to an equipment-connected PC, or remote.

In particular, the results may be translated in digital signals by standard techniques and subsequently transferred on a magnetic or optical memory, on print, on a graphic or alphanumeric display, etc.

Further components of the equipment 100 are at least one device presence sensor 121 and means 122 for reading an exam (test) identification code for which the device 1 in use is preset. This system may be a bar code reader or with ON/OFF precabled electric contacts, or even integrated in the logic interface reading system.

In this latter case the information is contained in the microchip memory, and therefore drawn therefrom.

However, such reading means 122 are in charge of dumping any information indicated in or stored on the device in the equipment 100. When the device is equipped with a writable memory storage medium, said reading means, with substantially conventional modifications, could operate as writing means, i. e. as read-in means, e. g. of the investigation results and of other data.

To the abovedescribed integrated device for carrying out an investigation a person skilled in the art, in order to meet further and contingent needs, may effect several further modifications and variants, all however comprised within the protective scope of the present invention, as defined by the annexed claims.