PT106367A - SYSTEM FOR DETERMINING THE BLOOD TYPE OF HUMANS AND RESPECT METHOD OF USE - Google Patents

Abstract

The present invention relates to a system and a working method for clinical analyzes and consists of a portable, reusable and low cost solution which allows the determination of the ABO-RH blood types in a simple, fast, safe and non-hazardous manner . THE FUNCTIONING METHOD IS BASED ON THE PREPARATION OF FOUR SAMPLES, REFERRING TO THE CONVENTIONAL PROTOCOL ON SLAUGHTER, WHICH SAMPLES OF TOTAL BLOOD AND COMMERCIAL SOLUTIONS OF TYPE A, AND, AB AND D ANTIBODIES ARE USED. THE SYSTEM WILL GO TO SPECTOPHETOMETRY TO DETECT THE REACTION OF AGGLUTINATION AND THEREFORE ANALYSIS AND IS COMPOSED BY A SCREEN, AN INTERMEDIATE BLADE (1) WITH FOUR CAVITIES OF TEST REGIONS (2) WHERE THE SAMPLES TO BE ANALYZED AND RESPECTIVE REAGENTS ARE PLACED; OPTOELETRONIC COMPONENTS, CONCRETELY, SETS OF LEDS (5) AND TO THEIR CONTROL ELECTRONICS, AND PHOTODIODOS (6) AND TO THEIR READING ELECTRONICS (7). This invention is characterized by reference to the measurement of three optical density values, for each region of the blade test, in specific wave lengths. THESE OPTICAL DENSITY VALUES ARE OBTAINED THROUGH THE LIGHTING SYSTEM WITH LEDS OR WITH WHITE LIGHT.

Description

1

DETAILED DESCRIPTION OF THE DRAWING SYSTEM FOR DETERMINING THE BLOOD TYPE OF HUMANS AND USING THE METHOD OF USE "

Field of the Invention The present invention is in the field of clinical analysis, consisting of a system for determination of human ABO-Rh blood type by detection of the agglutination of whole blood with the respective antibodies by spectrophotometry and respective detection method.

Background of the Invention The blood is comprised of several components. In general terms, it is formed by a main fluid, the blood plasma, and by cellular components. Of these, the erythrocytes are the most relevant, with respect to the determination of blood types, since they are the antigens present on the surface of these cells which define the blood type of an individual.

When it is desired to classify the blood type in a subject one usually refers to two blood systems, ABO and Rh. The ABO blood system is defined by the presence of antigens on the surface of type A (type A), type B (type B) or both (type AB blood) erythrocytes. There may also be erythrocytes which have neither A nor B antigens (type 0 blood). With respect to blood plasma, a subject with type A blood contains type B antibodies that attack type B antigens. Following the same logic, the blood plasma of an individual with type B blood contains type A antibodies. plasma of a given blood type contains the natural isoantibody (antibody A and / or antibody B) which corresponds to the antigen which is not present on the surface of its erythrocytes. For this reason the AB blood type does not contain any antibodies in its plasma, and the O blood contains antibodies A and B. The Rh blood system is quite complex with several antigens. However, the term Rh positive is usually used when an individual has a specific Rh antigen on the surface of their erythrocytes, the antigen D. In contrast, if the antigen D is absent the subject is said to be Rh negative.

Therefore, the existence of distinct blood groups causes that a patient can not receive any type of blood in its organism, since this one can contain antibodies that can attack the supplied antigens. Determining the blood type is thus an essential test that precedes the process of blood transfusion. This can be critical, especially in emergency situations, since the patient's condition is worrying and the time to determine his blood type is scarce. In addition, a transfusion of the wrong blood type can lead to high risks for the patient, or even death.

Existing blood type determination processes are divided into two major groups: manual testing and automatic systems. Manual methods are characterized by producing results very quickly, adapting to emergency situations. However, the final decision of the test depends on the technician who performs it. In addition, they are tests that are likely to cause human error, since all steps up to the final decision are dependent on the technical analyst. Regarding the automatic systems, these reduce some subjectivity, through the automation of the procedures and / or test decision. Moreover, they are quite accurate and reliable. However, there are 3 large complexes which make portability unfeasible, economically costly and fail to produce results as quickly as manual tests. This may be critical, especially in emergency situations.

Thus, the present invention appears as a solution to the described limitations, since it is a device that automates the process of blood type determination, which produces results fast, that can act close to the patient, due to its portability, thus being appropriate in emergency situations and is economically competitive. The determination of blood groups can be based on several principles, such as: the use of fluorescence markers, the use of selective porous membranes to clustered cells, the knowledge of the genetic information of the individual, or the measurement of optical transmittance or density of the samples.

Patent documents W09821593A1, US6955889B1, US5776711A and EP1059534A2 describe the use of fluorescence marker antibodies (types A, B and D) which bind to the corresponding antigens on the surface of the red blood cells. These are then identified by the flow cytometry technique, thus allowing determination of the blood type under analysis. This technology also allows the identification of antibodies in the corresponding blood plasma. US7718420 describes a portable microfluidic biochip for the determination of blood groups based on the detection of the agglutination reaction. The device contains a microchannel for the insertion of the blood sample, a microchannel system for the entry of the reagents, a system of micromixers to facilitate mixing between the reagents and the sample, a 4 reaction microchamber and also a microfilter of to retain the agglutinated cells that may have resulted from the reaction between the sample and the respective reagent and thus determine the blood type. US4851210 describes the use of an affinity membrane for specific regions of blood cells for the distinction of blood groups. This membrane may be coupled to a blood sample so as to constitute a device for sorting the blood type. The document US20060105402 discloses a device using a porous filter, specifically constructed to allow the passage of non-agglutinated cells in a perpendicular direction to the surface, thus allowing the classification of blood groups. US2009264318A1 discloses performing genetic tests on an organism as the unambiguous labeling form thereof, thereby making it possible to identify the antigens on the surface of the erythrocytes, and thereby determine the blood type, from the genetic information of the subject . US6330058B1 discloses the use of spectrophotometry for the determination of blood types. In this, the optical density spectrum of a diluted blood sample in the presence of a reagent also subject to dilution is measured over a wavelength range of 200 nm to 1000 nm. In addition, the reference spectrum of a control sample (respective blood sample diluted in saline) is also obtained. The reagents used are commercial antibody solutions (Anti-A, Anti-B and Anti-D), which allow the classification of ABO and Rh blood groups. Solutions are prepared in cuvettes, and optical density spectra are obtained in a commercial spectrophotometer. For each of the spectra is calculated a numerical indicator of agglutination, which is obtained by dividing the slope of the line into the linear region of the spectrum by the slope of the line in the linear region of the reference spectrum. The resulting value is then multiplied by 100. The agglutination index (IA) is obtained by subtracting the result at 100. A high AI value means that a bound sample (antibody-antigen interaction) is present; on the contrary, a low AI value means that there was no interaction between the antibody and the antigen present in the sample, i.e., the sample is non-agglutinated. This distinction between the two types of samples makes it possible to measure the blood type under analysis. In this type of procedure, it is necessary a spectrophotometer, equipment of great dimensions, which invalidates the portability and the possibility of being carried out the analysis in any place, mainly in emergency situations. In addition, the preparation of a control sample and samples involving reagent quantities greater than 100 ÂμL is required; it is necessary to make a set of dilutions of both the blood samples and the reagents; it is necessary to wait about 1 minute to obtain the reaction before the spectrophotometric measurements can be carried out; and specific conditions are required for such reactions to occur, such as the use of temperature controlled incubators. The invention relates to a non-portable system for detecting the immune agglutination reaction (detection of antibodies, antigens, proteins, among others). The agglutination reaction is detected by using an LED, and is based on the transmission pattern of the light emitted by the LED through a sample. This system has CCD sensors, such as light detectors, convex lenses, a CPU, a plate with conical bottoms, a multi-sample reservoir, and 6 motors for the movement of these plates. Blood type determination is based on the use of erythrocyte cells that are placed in the well plate together with antibody reagents. Afterwards, the optical transmittance of the sample is analyzed, taking into account the use of the LED / convex lens / CCD sensor. The patent document W09417212A1 discloses a portable system for detecting and monitoring an agglutination reaction as it is occurring, thereby allowing the detection of hormones, antibodies, antigens, among others. This system consists of a set of capillaries, for flow of the sample along the various stages of agglutination. In each of the capillaries, there is a LED / photodiode array for sample analysis, and the system monitors the particle agglutination (in the 3 capillaries) based on the light scattering properties of the particles, that is, changes in the optical density of the sample are monitored over time. Detection of the agglutination reaction is based on the difference in optical density that is measured in each capillary as the sample reaches the respective capillaries. It is a sequential measurement over time, that is, each sample is measured 3 times in 3 different instants of time and in 3 different capillaries. Thus, the purpose of the system is to detect the presence of the agglutination reaction and its type (strong or weak).

Contrary to all systems, devices and methods known and presented so far, there is provided a technology consisting of an automatic, portable blood grouping system based on a simple slide test protocol and the discrete measurement of three values of optical density per sample, at different wavelengths, using a Light Emitting Diode (LED) system, or alternatively in the use of only one white light and optical filters for the lighting system.

Thus, the preparation of the samples is quick, simple, without the need for dilution of reagents and involves the use of a reduced amount of antibody reagents, contrary to the patent US6330058B1, thus leading to a reduction of analysis time and reduction of costs with the expense of reagents.

Additionally, in determining blood type, the present invention uses whole blood, not erythrocyte cells as described in US5169601A.

SUMMARY OF THE INVENTION The present invention is a novel system and method for determining ABO-Rh blood type of humans, based on spectrophotometry. With this new system there is no need for control samples, it is quick, it eliminates the subjectivity associated with the interpretation of the results by the technicians and is simple, since the reagents and whole blood samples do not need to be subjected to dilutions, centrifugation or incubation at controlled temperature. The test protocol applied is based on the slide procedure used in the conventional manual test, thereby using a slide having four test regions, wherein the whole blood will be placed and in each region a type of antibody reagent consisting of commercial type A (Anti-A), type B (Anti-B), type AB (Anti-AB) and type D (Anti-D) commercial solutions. The system consists of four sets of Light Emitting Diodes (LEDs) (5) at a horizontal distance 8 equivalent to the distance between the regions of the blade. Each set of LEDs will comprise 3 LEDs emitting a wavelength range of 400 nm - 430 nm, 530 nm - 575 nm and greater than 750 nm, respectively. The advantage of each set comprises 3 LEDs due to accurate analysis of the sample, at 3 wavelengths relevant for the classification of the sample in agglutinated or unglued. The light beams will be incident perpendicularly on the samples and will be detected by the photodiodes (6), the system being controlled by a microcontroller which defines which LED is in operation and by current-voltage converters (7), in order to produce a voltage value proportional to the current generated by the photodiodes, and that can be acquired by the ADC (Digital Analog Converter) of the microcontroller. The choice of sample wavelength range was selected taking into account the optical properties of blood cells - absorption peaks of hemoglobin and also the alteration of the optical properties of whole blood with the state of agglutination of whole blood with the reagents antibodies. After conducting experimental tests with a commercial spectrophotometric system and applying the described detection method, it was possible to measure the 3 selected wavelength ranges, as the most suitable for the distinction of the two types of samples: agglutinated or non-agglutinated. Thus, for each wavelength, the light intensity detected by the photodiode (7) depends on the characteristics of the sample: agglutinated or unglued sample, which results in whether or not there is interaction between the antigen present in the blood and the antibody reagent, respectively. Preferably, the emission peaks at the wavelengths should be in the range of 406 nm, 566 nm and 956 nm, which are the 9 wavelengths within said range, which allow the correct and efficient distinction between agglutinated and non-agglutinated samples and , as a consequence, the determination of ABO-Rh blood types, according to the experimental tests performed. The microcontroller receives the three voltage values for each of the four wells of the test regions (2) of the blade (1), and based on reference voltage values, i.e., values obtained with only the reagents in a calibration phase of the system, calculates the three discrete values of optical density, by application of Lambert-Beer law.

After the calculation of the optical density values, the microcontroller performs a set of algorithms, in order to classify each of the samples in agglutinated or non-agglutinated. The algorithms of classification of the samples are based on the variation between the three values of optical density obtained by the three LEDs of the same set of LEDs, that is, for a given sample region. The variation between these three values of optical density is different according to the type of sample analyzed, agglutinated or non-agglutinated, thus allowing to classify each of the samples present in the cavity of the test regions. At the end, having the classification of the four samples, the type of blood under analysis can be measured since each type is characterized by binding with a specific group of antibodies.

More specifically, after determining the three calculated values of optical density, for a given sample and for wavelengths of 406 nm, 566 nm and 956 nm, the classification and decision algorithms are performed, using the following sequence, introduced in the microcontroller: The differences between the 3 values of optical density (OD) for a given sample are calculated using the following expressions: difference_l = sqrt ([OD [566 nm] -DO [406 nm]) * (OD [566 nm ] -DO [406 nm])); Difference_2 = sqrt ((OD [956 nm] - OD [566 nm]) * (OD [956 nm] -DO [566 nm]));

If the value given in difference_l is less than the value of a previously determined and experimentally variable (upper_limit) and if the value of difference_2 is less than a second variable also previously determined and experimentally (lower_limit), then the sample is bound together, to the variable sample the value of 1. If the two previous conditions are not verified then the sample is not agglutinated, being assigned to the sample variable the value of 0.

The values of the upper-limit and lower-limit variables are adjusted according to the values obtained by the experimental tests performed with standardized blood samples. In the experimental tests carried out using only the 3 wavelengths selected, it is possible to verify the limit values, the variables limit_major and limit_menor, that allowed a precise distinction between agglutinated and non-agglutinated samples, based on the knowledge of the blood type tested and the type of samples. Thus, for the two types of agglutinated and non-agglutinated samples, the mean values obtained for the difference-1 and difference_2 variables were determined and, on the basis of these average values, limit values were defined for the distinction of samples - upper limit 11 and lower limit, these values being classified as reference limits. The maximum limit value will be around 1.0 and the lower limit will be around 0.2.

Finally, the decision algorithm is executed, based on table 1, in order to conclude the blood type under analysis.

Table 1 - Device decision algorithm (X - agglutination).

Type Reaction with: Blood Anti-A Anti-B Anti-AB Anti-D A positive XXXA negative XXB positive XXXB negative XX AB positive XXXX AB negative XXX 0 positive XO negative The test result is displayed on the microcontroller display, thus providing information to the user, which screen may be tactile or not, and the test result may be stored on a micro SD memory card and / or transmitted to a computer via USB and / or wireless communication.

The LEDs must be circular with a diameter in the range of 5 mm - 30 mm, this range is suitable for the size of the light beam of the LEDs.

In terms of effectiveness, it is found that the optimum amount of the reagents for correct agglutination detection is 20æl 12 to 50μΒ and H of that total blood volume. That is, if in a region of the slide 20 pL is added to 50 pL of the whole blood anti-A and H reagent, another region should be placed 20 pL to 50 pL of the whole blood anti-B and H reagent in a region another 20 μl to 50 μl of the whole blood anti-AB and H reagent and the last 20 μl to 50 μl of the whole blood anti-D and H reagent. The material of the blade used should be transparent, being glass, polystyrene, among others, to allow the passage of light. The wells of the test regions need to have a flat bottom so as not to affect the optical measurement, but can have any shape, as long as it enables the light beams of the 3 LEDs of each set to be confined in that region.

During processing, it is necessary to ensure alignment between the light beam, the sample and the photodiodes, so that the beam crosses perpendicularly the test regions, which contain the samples.

It will be seen that the system shown allows for the separation of the agglutinated and unglued samples by varying the magnitude of three optical density values collected for each test region without the need for preparation of a control sample; and allowing greater reliability of the results since it is not based solely on the transmission of light through a capillary / well of a sample.

The present technology, in addition to allowing the rapid determination of blood type, adapting to medical emergency situations in the determination of human blood type, is characterized by its specificity and simplicity: use of only one disposable test slide. The test strip 13 may have any shape but must have a flat bottom, in order to allow a correct transmission of the beams of light emitted by the LEDs.

In a preferred embodiment, the utilization device is a portable device, consisting of circuits in an upper PCB board (3) (Printed Circuit Board) with the four sets consisting of three LEDs each (5) and electronic circuits to control which LED is in operation at each moment aligned parallel with the test slide and another lower PCB plate constituting the electronic reading portion of the device 4 formed by the photodiodes 6 and current-voltage converters 7. The arrangement of the PCBs and the test slide is parallel, and the reverse configuration is feasible (reading system at the top). In any configuration it is necessary to ensure alignment between the light beam, the sample and the photodiodes, so that the beam crosses perpendicularly the test regions.

In another embodiment, each of said LED systems may be replaced by a conventional white light with three band-pass optical filters, centered at the wavelengths of 406 nm, 566 nm and 956 nm, with about 20 nm at 30 nm bandwidth. These optical filters can be placed above or below the test slide.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows a blade (1) with four test region cavities (2), used for placing the samples in the system. Figure 2 shows the arrangement of the electronic components wherein (3) corresponds to the illumination system, (4) reading system relative to the test slide (1), (5) sets of LEDs, (6) photodiodes and (7) the current-voltage conversion blocks. Figure 3 shows a test result for a negative type A blood sample, i.e. the discrete optical density values for each of the wavelengths considered in the sample analysis. Figure 4 shows a second test result for a negative type B blood sample. Figure 5 shows an example of an end device, wherein (8) corresponds to the lid package (10), black in color for better light insulation, (9) the holder for the test slide. 6 shows the cover of the device 10 if the conventional white light is used with the optical filters, with four apertures 11, so as to allow the light beam to enter.

Detailed Description The present example is demonstrative and is not intended to limit the scope of protection.

Initially the sample will be prepared which consists of the following steps: 1. Add 20 μl to 50 μl of Anti-A reagent in one of the wells (2) of a slide (1) of a slide (1) in a further well (2) pL to 50 μl of Anti-B reagent, in another well place 20 μl to 50 μl of Anti-AB reagent and in another well place 20 μl to 50 μl of Anti-D reagent. 2. Add whole blood with about a quarter of the amount of reagent in each of the wells of the slide test regions; 3. Mix the blood and antibody reagent evenly, for about 5 seconds.

After the sample has been prepared, and after calibrating the system, that is, obtaining the voltage values with the use of only antibody reagents in the slide, the samples are then analyzed. The steps are: 1. Insert the blade into the system exactly in the location and position for the purpose, which causes the LED and photodiode arrays to align in parallel with the test regions; 2. The set of LEDs (5) and their electronic circuits come on, each of the LEDs alternately illuminating and a voltage value is acquired for each of them. This value is directly proportional to the amount of light received by the photodiode (6) in each measurement, generating an electric current which is then converted into a voltage by the conversion block (7); 3. Once the voltage values have been acquired by the microcontroller, the optical densities for each wavelength are calculated by the knowledge of the respective voltage values during the calibration and the application of the Lambert-Beer law; 4. Based on the calculated optical density values, the microcontroller performs the blood type determination, 16 based on the execution of the classification algorithms of each test region sample and its decision; 5. The test result is indicated on a screen, informing the user of the blood type under analysis. Figure 2 shows where the sets of LEDs (5) should be located; the test slide (1) and the photodiodes (7). Figure 3 shows the result obtained for a negative type A blood sample. As can be seen, a non-agglutinated sample (A-type blood negative in the presence of type B and type D antibodies) has higher optical density values and a greater variation over the considered wavelengths. In contrast, agglutinated samples (A negative blood type in the presence of type A and type AB antibodies) have a spectrum with reduced values of optical density and approximately constant between them. Such facts are in agreement with the theoretically expected and are explained by the theory of dispersion of Mie associated with the agglutinated cells, which leads to a existence of large amounts of light dispersed by these and consequently to a lower optical density in the obtained spectrum. Figure 4 shows the result obtained for a negative type B blood sample. In this case, although the optical density values for the two types of samples are smaller, which may be related to a lower hemoglobin concentration in the blood sample tested, it can once again be verified that the differences between the density values within the same sample, are distinct for the case where a sample is bound and not bound. Thus, the fact that the analysis 17 performed by the system integrates the measurement of 3 optical density values per sample, and the classification based on the differences between these three values, and not only on their magnitude, is a characteristic that allows to guarantee the accuracy of the result obtained. Figure 5 shows the configuration of an end device, the dimensions being adjustable according to the size of the test slide (1). The device is constituted by a holder which is in the central region (9) in order to fix the blade with the samples. The PCB boards (3) and (4) are on the top and bottom of the stand, depending on the configuration you want. The microcontroller and the batteries are attached to the top of the device. The device further has a cap (10) which engages the base (8) to insulate the external light so that it does not affect the optical measurements. Figure 6 shows a device for use with white light illumination and optical filters, which may be positioned above or below the test slide, the cap should have 4 apertures (11) positioned in the sample zone.

Braga, September 04, 2013

Claims (17)

Agglutination reaction detection system for determining human blood type, characterized in that it comprises: optoelectronic components positioned in the upper and lower zone of the system, wherein in the upper zone there are four sets of LEDs (5), wherein each set comprises three LEDs with wavelength ranges of 400 nm - 430 nm, 530 nm - 575 nm and greater than 750 nm, and control electronic circuits, and in the lower zone are four photodiodes (6), each oriented towards a set of LEDs, and current-voltage converters (7); - a test strip (1) placed between the set of LEDs and the photodiodes (6), wherein the test regions (2) are aligned parallel to the sets of LEDS and the photodiodes so that the beams of transmitted by the LEDs on the test regions; microcontroller for the control of the optoelectronic components and for the execution of the methods of analysis and interpretation of the values obtained by the photodiodes; - possible reading of the result. System according to the preceding claim, characterized in that alternatively comprising white light and bandpass filters instead of the LEDs. A method of detecting agglutination for determination of human blood type according to the system described in claim 1, characterized in that it comprises the following steps: a) calibrating the system by placing in each test region of the slide a reagent and activating the so that each set of the three LEDs emits the light beam, which will be collected by the photodiodes and converted to a voltage value, which will be read by the microcontroller; b) place the sample slide with whole blood and reagents, the test regions being parallel to the LED / photodiode array; c) activate the system so that the four sets of three LEDs emit a beam of light, this beam alternating between the three LEDs of each set, which beam passes through the sample to the photodiodes; d) generation of an electric current by the photodiode which is converted into a voltage by the conversion block (7); e) obtaining the voltage values through the microcontroller and calculating the optical densities for each of the wavelengths of the three LEDs of each test region sample, by obtaining the respective voltage values in the calibration step; f) calculate the differences between the three optical density values for each test region sample in order to obtain two results and compare with predefined limit values as reference values; g) perform the classification of the samples and the blood type decision, by the microcontroller; h) transmission of results obtained. and affects A method according to the preceding claim, characterized in that in steps a) and c) each of the LEDs in each set of LEDs alternately emits a light beam of wavelengths between 400 nm - 430 nm, between 530 nm-57 5 nm and greater than 750 nm, perpendicularly over the test region. 3 A method according to the preceding claim, characterized in that the emission peaks are preferably for each of the LEDs of each set 406nm, 566nm and 956nm. A method according to the preceding claim, characterized in that each of the photodiodes picks up the intensity of light passing through the test region and generates an electric current which is proportional to the amount of light received and to transmit to the current conversion block -tension. A method according to claim 3, characterized in that in step b) the sample preparation consists of placing in a slide region 20æl to 50æl of Anti-A reagent and H of that whole blood value; in another test region 20 μl to 50 μl of Anti-B reagent and H of that total blood value; in another 20 μl to 50 μl of Anti-AB reagent and Ή of that total blood value and in the last test region 20 μl to 50 μl of Anti-D and H reagent of that total blood value. A method according to the preceding claim, characterized in that the solutions are mixed manually for a period of 5 seconds. A method according to claim 3, characterized in that in step d) the photodiode generates three values of electric current, each for each of the three wavelengths of the LEDs, which are directly proportional to the amount of light passing through the test region, the value of which is dependent on the reaction between the blood and the reagent. A method according to claim 3, characterized in that in step f), the predetermined limit values as reference values consist of the uppermost limit 4, preferably 1.0, and the lower limit is preferably around 0.2. A method according to claim 3 and 10, characterized in that if the calculation of the two differences of the three optical values is below the reference limits, the sample is classified as bonded. A method according to claim 3 and 10, characterized in that if the results of the two differences of the three optical values are greater than the reference limits, the sample is classified as non-bonded. A method according to claims 3 to 12, characterized in that whole blood is used. A method according to claims 3 to 13, characterized in that alternatively white light and band pass optical filters are used instead of the LEDs. A method according to the preceding claim, characterized in that three optical bandpass filters of 20 to 30 nm are used, centered at wavelengths of 406 nm, 566 nm and 956 nm. An ABO-Rh blood type analyzer according to the system described in claims 1 and 2 and a method as recited in claims 3-15, characterized in that it comprises a PCB plate in which the LED sets and electronic circuits of control, and other PCB board where the photodiodes and the current-voltage converters are located, and the test result is displayed on a screen or further stored in a memory card 5 5 and / or and / or transmitted to a computer via USB communication wireless. previous, Device according to the claim characterized by being portable. Braga, September 04, 2013