MXPA99010273A - Automated microbiological testing apparatus and methods therefor - Google Patents

Abstract

Un sistema y método de prueba microbiológico de diagnóstico para identificación del microorganismos (ID) y determinaciones de susceptibilidad antimicrobianas (AST). El sistema incluye paneles de prueba de pozos múltiples capaces de llevar a cabo la prueba de ID y de AST en el mismo panel de prueba. Cada panel de prueba se inocula con reactivos, organismos sus pedidos en caldo, y se coloca en el sistema del instrumento. El sistema del instrumento incluye un. tiovivo giratorio para incubación y para indización, fuentes de luz múltiples cada una emitiendo luz de longitud de onda diferente, detección colorimétrica, y fluorométrica de precisión, seguimiento de panel de prueba de código de barra y un procesador de control para hacer determinaciones basándose en el dato de prueba medido. Una fuente de luz incluye una pluralidad de diodos emisores de luz colocados en una formación 1ineal. Cada una de las corrientes de junta de los diodos emisores de luz son controlables para producir un perfil de iluminación predeterminado.

Description

"AUTOMATED MICROBIOLOGICAL TEST APPARATUS AND METHODS FOR SAME" BACKGROUND OF INVENTION This invention relates to field of microbiological testing. e are many conventional systems to carry out tests on microbiological samples related to diagnosis and patient apy. microorganism samples can come from a variety of sources, including infected wounds, dental infections, cerebro-spinal fluids, blood and abscesses. From those samples of microorganism, an inoculum is prepared in accordance with established procedures that produce a bacterial or cellular suspension of a predetermined concentration. additional processing of suspension can defend test method used. e systems are used, for example, to identify which of microorganisms are present in a patient sample. Typically, in e systems, reagents are placed in test dome or test wells of identification trays which, in presence of a culture of actively growing microorganisms, change color. Based on color change, or lack eof, microorganism can be identified by use of reference frames. O systems have been developed for susceptibility testing of microorganisms. e systems are used to determine susceptibility of a microorganism in a sample to various apeutics, such as antibiotics. Based on e test results, physicians can for example prescribe an antimicrobial product that will be satisfactory to kill or inhibit microorganism. In particular, qualitative susceptibility test produces an indication of whe a microorganism is resistant or sensitive to a specific antibiotic, but does not provide an indication of degree of sensitivity or resistance of microorganism. On o hand, quantitative susceptibility test provides an indication of concentration of antimicrobial agent necessary to inhibit growth of microorganism. term minimum inhibitory concentration (MIC) is used to refer to minimum concentration of antimicrobial agent that is required to inhibit growth of microorganism. systems have certain inconveniences. For example, when identification and susceptibility test is carried out, test trays are incubated at a controlled temperature for a prolonged period of time. At predetermined time intervals, wells of test trays are examined individually for a color change indication or o test criteria. This can be a long and tedious process if it is carried out manually by a technician. In addition, incubation times for identification and susceptibility test trays may differ, or optimal time to read a test result from test tray may not be known in advance. efore, a technician would need to read and record results for a specimen for several different times, sometimes quite far apart, which can result in assignment or correlation errors. Automated systems are desirable to carry out e tests in order to minimize technician's handling time as well as to minimize possibility of human error. In addition, automated systems that obtain results quickly and accurately are preferred. In this regard, a microbiological test apparatus for automatic incubation and reading of microbiological test trays is already known. test trays of this apparatus have a plurality of wells containing samples or agents that go to - - try on trays are first placed in an incubator for a predetermined amount of time. test trays are moved to an inspection station. A light source is placed above tray and a couple of video cameras are placed under tray at inspection station. Each video camera takes a video image of an entire tray. video image signal of entire tray is sent to an image processor for analysis. image processor requires uniform illumination through inspection station. Consequently, the processor registers the level of background illumination of each pixel within an area of interest that corresponds to each step of the tray to account for the variability in the light source. The image processor processes the video image of the tray and determines the number of pixels for a specific well whose intensity exceeds a predetermined threshold for that area of interest. If the number of pixels exceeds a predetermined number, that well is assigned a positive result. The image processor analyzes the binary partial results from the wells to determine the possible identity of the microorganisms. The binary partial results are compared with pre-registered patterns of the results of each type of test tray in order to identify the sample in question. A microbiological test apparatus for detecting the presence of a fluorescence emitting reaction resulting from the interaction of a reaction agent and a sample for detection, susceptibility and identification test is also known. In this apparatus, multiple trays having a plurality of test chambers are contained within a roundabout. This roundabout is rotated to move one of the trays next to a detection area. A positioning mechanism then moves that tray radially out of the merry-go-round and into the detection area. A high-energy lighting source is placed next to the tray placed in this way. The light source provides narrow band light sufficient to produce emission fluorescence from the reaction within the test chambers, which in turn is detected by a video mechanism placed opposite the light source and behind the placed tray. The video mechanism produces an image based on the emission wavelength. Another test system for identifying bacteria is known using signals based on the intensity of monochromatic reflected light from specimens placed in a culture dish having a plurality of cells.

- A rotating disk containing six interference filters is interposed between a lamp and a group of optical fibers. The light from the lamp passes through a specific interference filter to produce monochromatic light of a certain wavelength. The filtered monochromatic light is guided by the optical fibers to make incidents on the respective cell of the culture plate. The disk is rotated so that the six monochromatic lights of different wavelength are caused to strike the cells in sequence. The light reflected from the specimens is guided by additional optical fibers towards the corresponding phototransistors. A signal is derived from each specimen based on the intensity of the reflected monochromatic light. These signals are then analyzed to determine the identity of the specimen by calculating the difference or relationship between the signals and comparing that result with a reference value. However, the apparatuses described above fail to meet all the requirements of a fully automated microbiological test system. In particular, they are not able to carry out simultaneously a test of both colorimetric and fluororimetric type in multiple well test panels that is necessary to obtain more accurate test results.

In addition, these devices are generally not designed to continuously collect test data from a plurality of multiple well test panels in a fast and reliable manner. Also, the automated processing of these systems is limited.

COMPENDIUM OF THE INVENTION The present invention provides a system that overcomes the problems described above. In particular, the present invention provides an automated microbiological test system that tests a plurality of multiple well test panels for identification and susceptibility, with a minimum amount of human intervention, during the testing process. In addition, this system carries out the test of both colorimetric and fluororimetric type. Also, this system quickly analyzes the collected test data to produce accurate identification and / or susceptibility test results. In particular, one aspect of the present invention is directed to a diagnostic microbiological test apparatus having a merry-go-round assembly in which a plurality of test panels are mounted. The test panel has a plurality of wells, each of which is inoculated with a test inoculum fluid to produce a reaction. A plurality of light sources direct light of a predetermined scale of wavelengths towards the wells of the test panels in order to cause the wells to emit or absorb light based on the reaction of the test inoculum fluid. A light detection unit, which may include a linear CCD, is positioned opposite the light sources with at least one test panel being placed between the light sources and the light detection unit. The light detection unit detects the light emitted from or absorbed by the wells of the test panels, as the roundabout set of the test panels continuously rotates between the light sources and the light detection unit to allow The light emitted from or absorbed by the wells of the test panels is detected by the light detection unit. A controller receives a plurality of signals generated by the light detection unit, corresponding respectively to the light that can be fluorescent or non-fluorescent, detected from each well. The controller then determines a test result for each well based on the received signals. In another aspect of the present invention, an incubation chamber is provided for an apparatus of - - diagnostic microbiological test. This camera includes a roundabout set in which a plurality of test panels are mountedeach test panel having a plurality of wells to receive a fluid from the test inoculum to produce a reaction. An envelope surrounding the carousel assembly prevents the intrusion of ambient light into the incubation chamber. The envelope has a door to provide access to the roundabout set. An impeller system continuously rotates the carousel assembly to directly place the test panels for testing by the diagnostic microbiological test apparatus. A heating unit heats the incubation chamber and the temperature controller controls the heating unit to maintain the temperature within a predetermined temperature range. Still another aspect of the present invention, the methods for operating and computer means including instructions for controlling a microbiological diagnostic test apparatus are provided of course. For example, a method includes the steps of (a) rotating a merry-go-round of a test apparatus to place a test panel mounted therebetween between a light source and a light detection unit of the test apparatus, (b) ) direct light from the light source to the test panels, (c) detect with the light detection unit, the light transmitted or emitted from, or absorbed by, each of the test panel wells due to the test reaction, (d) generate with the light detection unit a signal corresponding to the detected light from each of the wells, and (e) determine a test result for each of the wells based on the generated signal . In still another aspect of the present invention, there is provided an apparatus that includes a light source capable of producing a composite light signal having variable intensity light elements, and a controller adapted to control the light source using a lighting profile. The apparatus may also include a light detection unit and an optical system capable of directing the composite light signal to the light detection unit. The lighting profile can be used to correct optical inefficiency in the optical system or changes in the light output of the light source. In yet another aspect of the present invention, a light source is provided that includes a plurality of light emitting diodes placed in a linear array. The joint current of each light emitting diode is controllable to produce a predetermined lighting profile.

In still another aspect of the present invention, a light source includes a plurality of light emitting diodes placed in a linear array having two ends, each end having a group of light emitting diodes of the plurality of light emitting diodes. The group of light-emitting diodes is geometrically compressed to produce a greater intensity of light. The light emitting diodes may include red, green and blue light emitting diodes, placed in a predetermined order in the linear array. In a further aspect of the present invention, an optical system for a microbiological test apparatus is provided.

BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects, features and advantages of the present invention will be better understood by reference to the detailed description of the preceded modalities indicated below that are taken with the drawings, in which: Figure 1 is a front perspective view of the apparatus of the present invention, with the enclosure door closed.

Figure 2 is a front perspective view of the test apparatus of the present invention, with the envelope door open. Figure 3A is a perspective view of an ID / AST test panel of the present invention. Figure 3B is a top view of an ID / AST test panel of the present invention. Figure 3C is a bottom view of an ID / AST test panel of the present invention. Figure 4 is a schematic top view of the internal components of the apparatus of Figure 1. Figure 5 is a schematic perspective view of the merry-go-round assembly of the present invention. Figure 6 is a perspective view of the panel carrier of the present invention. Figure 7 is a schematic perspective view of the tower of the measurement system of the present invention. Figure 8 is a schematic perspective view of the CCD detection module of the present invention. Figure 9 shows a mode in which the solid state light emitting diodes and the dichroic color separation filters are used.

- - Figures 10A and 10B are respectively front and side views of another embodiment in which the surface mount light emitting diodes and color separation filters are used. Figure 11 is a schematic view of the configuration of the light bridge assemblies of the present invention. Figure 12A shows a graph of a lighting output from a light source module. Figure 12B shows the graph of a lighting profile used to drive the light source module of the present invention. Figure 12C shows a graph of an illumination output from the light source module of the present invention resulting from the illumination profile of Figure 12B. Figure 13 shows a circuit for controlling a module of the light source of the present invention. Figure 14 shows a modality of a module of the light source of the present invention. Figure 15 is a schematic perspective view of a portion of the panel carrier and the test apparatus of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The present invention provides a system and method for carrying out highly reliable microorganism identification (ID) determinations and antimicrobial susceptibility determinations (AST). The present invention determines the identification and susceptibility based on the readings of the wells 31 contained in the ID / AST panels 30 (see Figures 3A and 3B). For example, in one embodiment, the wells 31 contain different reactive substrates and / or different antimicrobial dilutions, which change the optical character some time after being inoculated with the organism. The detection method described below measures changes in absorption, dispersion and / or fluorescence. It can also measure the luminescence. These changes are processed to determine the identification and susceptibility of the microorganism. The present invention allows a technician, for example, after inoculating the wells 31 of the ID / AST panel 30 with an unknown microorganism, to place that panel on an instrument 20 (shown in Figure 1) where it is incubated at a established temperature, periodically interrogated for changes and analyzed for microorganism identification and antimicrobial susceptibility. The apparatus 20 retains a plurality of ID / AST panels 30 and provides positive analysis results to the technician, as will be described below. As shown in Figures 3A-3C, the ID / AST panels 30 are disposable devices that are inoculated with reagents necessary for both the ID and AST test. The test is carried out on the reactions generated by the samples and the reagents placed in the individual wells 31 in each ID / AST panel 30. The wells 31 are placed in the ID / AST panels 30, as a two-dimensional array having rows and columns. The instrument 20 is integral and autonomous enough to test the ID / AST panels 30 and provide the appropriate test results. The instrument 20 stores, incubates and reads the ID / AST panels 30. The instrument 20 has a door 21 shown closed in Figure 1 and open in Figure 2, to allow access to the interior of the instrument 20. In one embodiment, as also shown in Figure 1, a workstation 40 of a computer personnel (PC) communicatively connects with the instrument 20. The PC work station complements the microbiology information system of the instrument 20, disclosing and managing data particularities that will be discussed below. The work station 40 - - of PC provides tools to improve the decision of empirical therapy and to identify cases of therapy intervention. PC workstation 40 also incorporates informing about tools to help control infection and epidemiology. In addition, the PC workstation 40 incorporates a relationship database (not shown) in a hard driver. The completed AST and ID test results are retained in the database for a minimum of 52 weeks. The statistically summarized data is retained for a longer period of time. The patient information of the specimen can be collected through an electronic interface with the instrument 20 (not shown) or manually admitted, and the PC workstation 40. The instrument 20 includes a merry-go-round 50, as shown in Figure 2. The merry-go-round 50 includes a set 51 consisting of rings and ribs fixed with bolts on a driving ring 52 to form a cylindrical cage, as shown in Figure 5 The roundabout 50 is mounted vertically in an enclosure 60 of the instrument (shown in Figure 1). The envelope 60 of the instrument defines the compartment 61 of the merry-go-round and an electronic compartment 62 (shown in Figure 4). The merry-go-round compartment 61 is isolated to provide an essentially uniform temperature incubation environment and is airtight under normal operation to prevent ambient light from entering. The panel carriers 53 (shown in Figure 6) are mounted on the assembly 51 which forms four horizontal rows with each row having twenty-six panel positions. A total of one hundred four panel positions are proposed. Of course, these numbers of rows and panel positions are only one example and can be changed to suit the requirements of any specific application, as will be appreciated by a person skilled in the art. The panel carriers 53 are used to mount the ID / AST panels 30, as well as other types of panels that will be discussed below. The panel carriers 53 are designed in such a way that the incorrectly seated panels will not be retained by the panel carriers 53. When the ID / AST panels 30 are mounted on the four rows of the assembly 51, they are placed to form essentially circular rows and vertical columns of the wells 31. Within each row, the panel positions are numbered from zero to twenty-five. The zero panel position is reserved for a normalization panel and is not accessible by the operator during normal operation of the instrument 20. As shown in Figure 15, the indicator light emitting diodes 54 are used to indicate which - ID / AST panels 30 must be moved (ie, when the test is completed) and which panel positions are available for the new untested ID / AST panels 30. The indicator light emitting diodes 54 can be placed forward or behind each panel carrier 53. For example, as shown in Figure 15, the indicator light emitting diode 54 is mounted on a printed circuit board 57 behind the carrier 53 of the panel, which is placed against a rib 58 of the merry-go-round. A light guide 59 can also be used to focus the light from the indicator light emitting diodes 54 through a convex indicator surface. The indicator light emitting diode 54 may be a three color light emitting diode where different colors are used to indicate status / test information. For example, the red light may indicate that a test is underway; the green may indicate that the test has been completed; and the yellow may indicate that the position of the panel is available for a new panel 30 of new ID / AST not tested. The carousel 50 also includes a drive system 56. The drive system 56 is mounted within the enclosure 60 of the instrument and is outside the cylindrical cage formed by the assembly 51., as shown in Figure 4. The drive system 56 drives the assembly 51 through the drive ring 52 at predetermined speed and angular controllable. A complete rotation of the merry-go-round 50 is used to acquire and accumulate the test data of only one light frequency from each ID / AST panel 30 mounted within the assembly 51 (i.e., a data accumulation cycle). A precision, gradual motor is preferably used to provide accurate rotation control of the assembly 51. Of course, other types of motors including servomotors, synchronous motors and direct current motors may be used, for example. _ An oil-treated felt pad is placed against the drive ring 52 to ensure that it remains properly lubricated. A poly-alpha-olefin oil or similar oil can be used to minimize spraying and oil migration. In a preferred embodiment, a system carrying free lubrication can be used. A base position flag magnet is fixed on the inner surface of the drive ring 52 corresponding to a zero position of the assembly 51. As the assembly 51 rotates, a signal is generated by the Hall effect sensor 55, mounted inside the merry-go-round 50 each time the magnet passes from the base position flag. This signal is used by the instrument - - to maintain the position of the panel as the assembly 51 is rotated. Of course, other types of sensors may be used for this object. For example, infrared and optical sensors can be used instead. The temperature inside the merry-go-round compartment 61 is controlled by means of an incubation heater, a blower and an associated duct (none of which is shown) that distribute and recirculate the incubation air. The incubation heater includes one or more sensors 63 (shown in Figure 11) to monitor the temperature inside the carousel compartment 61. The incubation heater includes two heating elements wired in a three-conductor arrangement (not shown). A self-reset thermal circuit breaker is provided in the driver __as a third party to protect against overheating conditions of the heater. In case the temperature of the merry-go-round compartment 61 rises above a predetermined first point, the energy is interrupted towards the heat. The energy is reapplied when the temperature decreases to less than a second predetermined set point. The energy supplied to the heater is controlled by a control processor 70.

Preferably, the merry-go-round compartment 61 is continuously maintained at a temperature of 35 ° C when the first and second predetermined set points are set at the temperature of 39 ° C and 33 ° C, respectively. However, as will be appreciated by a person skilled in the art, other temperature settings may be used to achieve the specific test requirements. In one embodiment, four bar code scanners (not shown) are mounted on an explorer tower (not shown) positioned within the carousel compartment 61, either inside or outside the circumference of assembly 51. A code scanner bar is provided for each row of set 51. The bar code scanners are capable of reading the modified bar tags (not shown) set in each ID / AST panel 30 as the combs are rotated through the bar. set 51. The bar code scanners are held in proper relationship with respect to the ID / AST panels 30 mounted on the assembly 51 and maintained at an appropriate scanning distance by the survey tower. The information read by the bar code scanners is used by the instrument 20 to correlate the specific panel sequence numbers to the test data collected from the panels. Preferably, bar code scanners are capable of reading the numerical information of Code-128. However, other known conventional bar code formats may be used, instead of labeling to mark the ID / AST panels 30. In another embodiment, a bar code reader (not shown) is installed behind the front panel 71 of the instrument. The bar code reader is used to scan the bar code labels affixed to either side of the ID / AST panels 30 before the ID / AST panels 30 are mounted in the compartment 61 of the merry-go-round. This allows, for example, that the operator fix information encoded by supplementary bar in each panel 30 of ID / AST. The information encoded in supplementary bar could for example be an access label applied to a hospital. In this embodiment, the bar-coded labels can be scanned and the specific ID / AST panel 30 can then be flipped over to scan the information encoded into the supplementary bar and this then links the ID / AST panel 30 into the information encoded in with the supplementary bar. . The conventional bar code formats are held by the bar code reading apparatus. In another embodiment, a manual scan bar code bar 72, as shown in Figure 1, is operably connected to the instrument 20. The bar code bar 72 can be used in the same manner as the code reading apparatus. bar (vg, to scan the access link generated by the operator in order to scan the bar codes too large to be fixed in the ID / AST panels 30. The conventional bar code formats are held by rod 72 of bar code. A sensor for panel position for each row is also mounted on the survey tower. The panel position flags integrated with the panel carriers 53 are read by the panel position sensors. During scanning, the front edge of the panel flag position flags, the panel position sensors generate a signal used to provide the acquisition time of the test data for each ID / AST panel 30. As shown in Figure 4, a plurality of light source assemblies are mounted within carousel compartment 61 and outside of the circumference of assembly 51. In a preferred embodiment of the present invention, the light source assemblies comprise an assembly 80 of visible light source and a set 81 of ultraviolet (UV) light source (shown in Figure 11).

The visible light source assembly 80 includes four visible light source modules and a support tower. The support tower aligns one of the visible light source modules with each row of the assembly 51. At any given time, a column of the wells from the ID / AST panels 30 can be illuminated by the modules of the visible light source. In one embodiment, each visible light source module includes three parallel vertical columns of 66 light emitting diodes (LEDs) each. The first column consists of the red light emitting diodes, the second one of green light emitting diodes and the third one of blue light emitting diodes. A holographic diffusion plate 82 is placed in close proximity on the ID / AST panels 30 mounted on the assembly 51. The holographic diffusing plate 82 diffuses the illumination energy from each column of the light emitting diodes (when energized). Each column of light-emitting diodes is mounted on the modules of the visible light source to maintain a fixed distance from the diffusion plate 82. Cylindrical lenses can be used to focus the illumination energy from each column of light-emitting diodes towards the Vertical well columns of the 30 ID / AST panels. The lighting axis for each column of light-emitting diodes is made to match for red, green and blue illumination. Therefore, each column of the well sees a uniform strip of either red, green or blue illumination, depending on which column of the light-emitting diodes has been energized. Each visible light source module is also equipped with a partially reflective beam splitter. The beam splitter would cause a portion of the illumination energy of the light emitting diodes to impinge on a source monitor photodiode 84. The signal from the photodiode 84 source monitor is then used to correct the light intensity of each of the columns of the light emitting diodes, as necessary. For example, the signal from the photodiode 84 of the source monitor can be used to compensate for fluctuations in the output of the illumination during heating of the light emitting diode at the time when its operation is initiated through a lighting profile to be discussed. then. This allows the instrument 20 to start testing more quickly because the test would not have to wait for the light emitting diodes to heat up (ie, to reach a constant state lighting output). The visible light source modules are vertically spaced and properly positioned with respect to the ID / AST panels 30 mounted on each row of the array 51 by the support tower. The support tower may also include mounts for beam splitters, holographic diffusion plates 82 and cylindrical lenses. In another embodiment shown in Figure 9, other arrangements for the visible light source used in the present invention are possible. Figure 9 shows a top view of an arrangement of three spectra (e.g., red, green and blue) using three light-emitting diodes (215, 216, 217). A group of about three light-emitting diodes can be used at any location on a single Z-axis. The groups of light-emitting diodes can be stacked as deeply as necessary in the direction of the Z-axis, in order to cover all the length of the 30 ID / AST panels. The light from the light emitting diode 216 is reflected at 90 ° by a first surface mirror 218 along the axis of illumination. A certain amount of this light passes through the dichroic filters 220 and 219, dividing to a holographic diffuser 221 in the X direction. A certain amount of the light is rejected by each filter and continues through in the Y direction. The holographic diffuser 221 it acts to homogenize the light in a definite way. The filtered homogenized light passes through a cylindrical lens 222 which concentrates the same towards the homogeneous light strip of a width indicated in the ID / AST panel 30. A portion of the light focused on the ID / AST panel 30 is redirected at 90 ° by an optical section 223 of flat glass to a lighting pipe 224 which concentrates it towards a monitor 225 of the source. A signal generated by the source monitor 225 is used to correct the light intensity of each of the groups of light-emitting diodes, as necessary. Similarly, a certain amount of the light from the light emitting diode 217 is reflected at 90 ° by the dichroic filter 219, and this filtered energy is processed optically in the manner described above. Again, a certain amount of light from the light emitting diode 215 is reflected at 90 ° by the dichroic filter 220 and this filtered energy is processed optically by the remaining components in the optical train, as described above. In another embodiment, a set of solid state visible light source is shown in Figure 10A. A plurality of surface mountings of light emitting diodes 300 (SMLED) are placed in a formation that coincides with a column of wells 31 of the ID / AST panels 30. The SMLEDs are placed in a repeated pattern in the formation, for example, the first SMLED can be red, the second green and the third blue. This pattern is then repeated throughout the length of the formation. As many SMLED groups as necessary can be placed to properly illuminate the desired area. In this embodiment, the illumination axis of the SMLED formation is placed on the same line as handcuffs 31. Consequently, SMLED 300 are energized based on their respective spectral content, ie, red, green or blue illumination). As above, this light is further conditioned to homogenize and concentrate it towards the target using a holographic diffuser 301 and a focusing lens 302, as shown in Figure 10B. As described above, a beam splitter and a source monitor are also used in this mode. Because the intensity of illumination tends to fall from the ends, each column of light-emitting diodes, the holographic diffuser plate 82 and the cylindrical lens can physically become longer than the active area of the ID / AST panels 30. In order to compensate for the drop of light in the ID / AST panel 30, the extremes caused by the optical inefficiencies, the intensity of illumination near the ends of each column of light emitting diode is reinforced to improve the uniformity. One way this can be achieved is by driving the light-emitting diodes near the ends of each column with higher currents, which increases the intensity of the light at those extremes. The joint current used to drive the light emitting diode or the SMLEDs, discussed above, can be controlled using a computer program "stored in the control processor 70, as shown in Figure 13. Illumination profiles can be used to dynamically drive the light-emitting diodes to compensate for optical inefficiency, as shown in Figure 12A, when the light-emitting diodes of a column are all driven with the same driving current, their illumination performance from the light emitting diodes at the ends (ie, upper and lower) of the columns, as measured by an optical detection system 100, is less than the illumination performance from the light-emitting diodes near the center of the column Figure 12B shows a lighting profile in which the light emitting diodes at the ends of the column are driven with a higher current. yor lighting performance from the light-emitting diodes at the ends of the column, as compared to the light-emitting diodes near the center of the column. Figure 12C shows the resulting illumination performance as measured by the optical detection system 100 of the column of the light emitting diode when it is driven by the illumination profile of Figure 12B. Even when the illumination profile of Figure 12B shows a complementary profile used to produce a uniform illumination performance, a variety of illumination profiles can be used. These profiles can be selected based on different criteria such as the type of test panel used, the type of test that will be carried out or the feedback signals. For example, a feedback control circuit provided using signals from the photodiode 84 of the source monitor can correct changes in light intensity during the test, during heating of the light emitting diode or during long term degradation of the current of the light emitting diode gasket. Other types of feedback correction systems can be based on temperature changes within the instrument 20 or on the signals of the normalizing panel, which will be discussed below. Another way to compensate for the elimination of intensity at the ends of the column is to geometrically compress the separation of the light emitting diodes or the SMLEDs at the ends of each column, ie, a light emitting diode configuration stacked at the ends. As shown in Figure 15, the light emitting diodes 90 at the ends of the linear array are geometrically compressed. This type of configuration compensates for the degradation of optical efficiency at the ends of the columns. When the light-emitting diodes are placed closer together, the intensity of the illumination increases. Preferably, the light emitting diodes should be compressed to produce an inverse current to the scavenger. For example, a 90-percent optical coupling elimination at the ends of the column (relative to the center of the column) can be compensated for by decreasing the center-to-center distance of the light-emitting diode at the ends of the column by a factor of 10. Returning to Figure 11, the ultraviolet light source assembly 81 includes two tubular UV cold cathode lamps. The hot cathode lamps can also be used. Suitable lamps can be obtained from Voltarc (VTI, aterbury, CT 06705). The radiation passes through the excitation filters 85. The excitation filters 85 eliminate the unwanted spectral components present in the output or performance of the lamps. As shown in Figure 11, the lamps are placed on either side of the primary lighting axis, so that a column of vertically aligned ID / AST panels 30 are illuminated simultaneously. There is no need to align ultraviolet light sources along the primary illumination axis. The adjustment of the intensity of the illumination is carried out by altering the high frequency energy applied to the lamp and its inductance in series. This is controlled by the control processor 70. Only one lamp is illuminated at a time. The other lamp is retained in reserve. In this embodiment, the fluorescence reaction is simulated through a mode of direct transmission of light through the wells 31. However, a reflective mode that would require re-positioning of the ultraviolet light sources can also be used. A photodiode 86 of the ultraviolet source monitor for each lamp is placed to intercept a small portion of the radiation that leaves the lamp. The resulting signal is used to monitor the intensity of the lamp. This signal also allows the control processor 70 to detect a decrease in the intensity of the lamp so that, if necessary, another backup lamp can be activated. The active lamp is operated at full power only when ultraviolet excitation measurements are being taken. Otherwise, the lamp is dimmed to low power to conserve lamp life or is switched off to prevent optical interference with readings using the visible excitation light sources discussed above. In addition, an emission filter 83 (shown in Figure 11) is used to eliminate any of the unwanted spectral components that may be introduced by the lamps. For example, the emission filter 83 filters the ultraviolet light wavelengths of the lamp. The lamp current rises to the operating level for the acquisition of test data by means of a signal line controlled by the control processor 70 (i.e., switching of the lamp from a low to high intensity operation). The supply 92 of ultraviolet source energy energizes the active lamp. As discussed above, adjusting the intensity of the lamp is achieved by varying the frequency of the high voltage excitation applied to the lamp and its inductance in series. An increase in the frequency causes a decrease in the lamp current as the inductive reactance increases, which in turn causes a decrease in the intensity of the lamp. The ultraviolet source power supply 92 also includes high voltage sheet relays (not shown) for transferring energy from the active lamp to the reserve lamp as regulated by the control processor 70. As discussed above, lamp transfer occurs when the photodiode of the source monitor detects a significant decrease in the intensity of the active lamp. During operation, the visible light source assembly 80 and the ultraviolet light source assembly 81 are energized in sequence. After a complete rotation of the merry-go-round 50 (i.e., a data accumulation cycle), another type of wavelength illumination is energized. For example, in one arrangement, a column of the light emitting diodes (ie, red, green and blue) contained in the visible light source modules are energized in sequence, then the ultraviolet light source module is switched on full energy, each light source being active during a complete rotation of the merry-go-round 50. This allows the instrument 20 to collect the test data from each ID / AST panel 30 based on the different types of wavelength light. In a preferred embodiment, the sequence is the ultraviolet light heating, the ultraviolet light reading followed by red, green and blue readings. As shown in Figure 4, the optical measurement system 100 is placed approximately within the center of the assembly 51 such that it is aligned with the visible light transmitted through each well 31 of the ID / AST panels during excitation with red, green or blue lighting of the visible light source modules. Visible fluorescent radiation is similarly detected from wells 31 excited by ultraviolet light. As discussed above, the emission filter 83 removes unwanted spectral components that may be present in the output signal prior to detection by the optical measurement system 100. In another embodiment, near infrared light (IR) may be used. ) to carry out the optical test scans. As will be appreciated by a person skilled in the art, a variety of means can be used to measure changes in optical characteristics. For example, photodiodes or a formation of photosensors can be used. In a preferred embodiment, a plurality of CCD detector modules 101 and lens assemblies 105 are provided. (shown in Figures 7 and 8), one for each row of the assembly 51. The CCD detector modules 101 and lens assemblies 105 are held in a tower 103 of the measurement system. The measuring tower 103 holds the lens assemblies 105 and the CCD detector modules 101 so that they are oriented in alignment with the optical axis of the well column of the ID / AST panels 30.

The lens assemblies 105 include an objective lens 102. The light from each column well column is focused toward the CCD formations 104 by the objective lens 102. Each CCD detector module 101 includes a CCD array 104. A linear CCD formation of 2048 pixels, for example, can be used, of course. The CCD formations 104 detect and measure the intensity of the light transmitted through each well 31 when illuminated by the red, green and blue light emitting diodes. Visible fluorescent light is similarly detected by the CCD formation 104 under the excitation of ultraviolet light. Alternatively, the ultraviolet light excitation may be positioned in such a manner that the CCD formations 104 detect visible fluorescent light reflected or absorbed from the wells 31. The CCD formations 104 are positioned relative to each row to provide over-scanning of wide illumination of all locations of the wells 31 in any column of the ID / AST panels 30. The only light detectable by the CCD formations 104 is the monochromatic light passing through them or the visible fluorescence emissions from the wells 31. In this way, the CCD 104 formations detect and measure the intensity of the light from the wells , but not of any - - another object illuminated by the light source assemblies. The Y-axis column information representing a vertical information loop is electronically scanned by the CCD 104 arrays. Multiple loops of information are required to detect and measure the intensity of light from a well column. The X-axis information is accumulated with the rotation of the assembly 51 (ie, the ID / AST panels 30 are rotated so that the next vertical information slice can be scanned). The sensitivity of the CCD detection modules 101 is regulated by the selected integration time for each CCD array 104. As will be understood by a person skilled in the art, light is composed of individual photons. Each photon has an extremely small amount of energy associated with it. The amount of time needed to load the pixels is called the integration time. The variable amounts of photons emitted from or absorbed by the individual wells 31 are incident on the individual pixels within each CCD array 104 and load the pixels at different levels in proportion to incident light. The integration time for the CCD formations 104 in the present invention is variable. This provides the present invention with the flexibility of having ID / AST panels 30 containing substrates with a variety of optical (i.e., transparent or optically dense) properties. From the information collected from the bar code label, the integration time is adjusted to control the gain for each ID / AST panel 30. The integration time for each next ID / AST panel 30 is adjusted before it is illuminated by the light sources. In one embodiment, a failure integration time is selected as being approximately 4.0 milliseconds. Other integration times can be selected by the control processor 70, as needed during the testing of ID / AST panels 30. The data processing of the accumulated pixel information is achieved by four detector microcontrollers (and the backup circuit) 106, one for the CCD detector module 101. Each detector microcontroller 106 receives and processes the data of the associated CCD formations 104. This data is collected from each well 31 when illuminated by the red, green and blue light emitting diodes and excited by ultraviolet light during rotation of the ID / AST panel 30 through the assembly 51.

In operation, the detector controllers 106 use the panel flag signal generated by the panel position sensors to initiate the acquisition of panel data through the CCD formations 104. As mentioned above, the flag signal of panel is generated as the panel position flags pass the panel position sensors during rotation of the assembly 51. This signal is used as the starting point of the time to collect the test data. The roundabout 50 rotates continuously while the detector microcontrollers 106 receive the test data collected by the CCD formations 104. In this embodiment, the CCD 104 formations measure more than one variable in parallel (absorption, turbidity and / or fluorescence) from essentially the same spatial location. The measurements are taken by the linear CCD arrays as the ID / AST panels 30"float by". All of the detector microcontrollers 106 simultaneously receive the test data of the CCD formations 104 as a column of the well of the ID / AST panels 30 is illuminated by the light of the visible light source assembly 80 or is excited by the set 81 of ultraviolet light source. A registration mark (not shown) in each of the ID / AST panels 30 is placed performing an algorithmic inquiry in the series of data scans of the linear array. Knowing how many steps of the gradual motor of the drive system 56 have occurred between the synchronization starting point and the registration mark, in addition to the pixel of the first CCD formation 104 where the registration mark begins, provides the information necessary to locate precise any well 31 in panel 30 of ID / AST scanned. There are two light source normalization processes that occur during the process of acquiring the test data. The first reduces the effects of spatial non-homogeneities from well to well. The second normalization process involves monitoring the instantaneous source intensity simultaneously with the acquisition of the test data from the CCD training 104. A normalizing panel serves as a reference panel for instrumental correction of the optical measurement system 100. Each row from set 51 contains a normalizer panel that remains at a position location of zero in each row. The normalizer panel contains a matrix of absorbers in the well format of the ID / AST panel. The normalizer panel is constructed in such a way that it has a nominal geometry equivalent to the ID / AST panels 30. The normalizer panel readings do not change over time and transmit the same intensity of light when they are illuminated uniformly. By measuring each well performance of the normalizing panel, a correction factor is created for each well in order to eliminate any of the non-uniformities in the well-to-well source intensity, in order to correct the individual well signals for losses that occur in the optical system, and to compensate for the reduction in the performance of the light-emitting diode over time. The collected test data of each ID / AST panel 30 in a row of set 51 is corrected (normalized) for any changes in the optical system since the normalizer panel for that row was read last. In one embodiment, a selectively energized monochromatic light source provides linear illumination for a column of uniform wells of the normalizing panel. The profile of the intensity of illumination along the column is by pieces that are adjusted to provide a uniform detector response for all the wells in the column of the normalizing panel. The columns of all ID / AST panels 30 are then illuminated with that profile. The optical response of the normalizer of each well in the ID / AST panel 30 is thus measured with uniform sensitivity for all well locations within each column.

As mentioned above, the signal from the source monitor photodiode 84 is used to determine any of the changes in light intensity of the visible light source assembly 81 as the merry-go-round assembly 51 rotates. While the normalizing panel is used to monitor the relative spatial variations in intensity, the source monitor photodiode 84 allows the present invention to monitor the near absolute intensity as it fluctuates through a single rotation of the merry-go-round assembly 51 or varies to over a long period of time. The source monitor photodiode 84 is monitored simultaneously with each acquisition of the CCD array. The detector microcontroller 106 has two correction factors to be explained to each set of the collected test data so that any of the differences between the test data scans are due solely to the optical properties of the reagents in the wells 31. Each Detector microcontroller 106 also receives data from a dark current CCD scan. The dark current correction is applied to the data on a per-pixel basis. In an alternative embodiment, a fluorescent visible light source and a filter wheel (not shown) may be used instead of the visible light sources discussed above. The filter wheel contains a plurality of spectral filters. In this embodiment, for example, absorption and turbidity measurements are acquired in three consecutive rotations of set 51, while fluorescence measurements are acquired during a fourth rotation. When completing the first rotation for normalization and location of registration marks (this is done for each of the panels per row), the filter wheel is indexed to its first spectral filter. Upon reaching the normalizing panel, the filter wheel is placed on the second spectral filter. The acquisition of test data, normalization and computation process, as described above, are repeated for each spectral filter within the filter wheel. After the colorimetric measurements are carried out, the visible fluorescent source is switched off. The filter wheel places an emission filter and the fluorescence measurements are taken in a similar manner. In order to reduce the post-processing load, all pixel information not associated with ID / AST panel wells is eliminated. For example, the analog signal of the CCD array 104 can be digitized and the detector microcontroller 106 can then process the digitized signal accordingly. The test data for each well 31 (ie, the light intensity information) is then averaged. The averaging is carried out based on a value per pixel received from the CCD formation 104 for each well 31. The averaging yields a single integer value for each well 31. A numerical value is produced for each data accumulation cycle (i.e. , red, green and blue lighting, and excitation of ultraviolet light). This information is then sent through a multicast serial data transmission protocol to the control processor 70. In one embodiment, the spatial averaging of an analog signal from the CCD formations 104 is carried out by the detection microcontroller 106 in order to eliminate unwanted optical and electrical artifacts from the data of the sample column. Spatial averaging is carried out using partial analogue deconmutation of pixel intensity and analog signal. As shown in Figure 4, the control processor 70 is mounted in the electronic compartment 62 of the enclosure 60 of the instrument. The control processor 70 includes the front panel 71 of the instrument, a keyboard 72, an impeller 73 of the computer readable medium (e.g., impeller disk or CD-ROM drive floppy disk), and an audible loudspeaker alarm. The control processor 70 also includes an I / O interface board, a CPU, a memory, an Ethernet interface circuit, a presentation drive circuit (none of which is shown). The control processor 70 can also be provided by a mouse. During the operation, the control processor 70 carries out the following functions by executing the instructions stored in a computer readable medium. The control processor 70 detects the magnet of the domestic flag in the drive ring 52 through the Hall effect sensor 51. This is carried out in order to properly place in the ID / AST panels 30 which are mounted in the assembly 51, while being rotated. The high level commands are sent to the detector microcontrollers 106 to start or stop the testing of the ID / AST panels 30. The intensity of the ultraviolet light source assembly 81 is controlled based on the photodiode signal 86- of the ultraviolet light source monitor. The control processor 70 illuminates the light emitting diodes 54 status indicators on the panel carriers 53. The indicator light emitting diodes 54, as discussed above, identify which of the ID / AST panels 30 have been tested and can be removed from assembly 51. The incubation temperature is also controlled by the control processor 70 through the signal / control lines - connected operably with the incubation heater. The control processor 70 also receives the data generated from the bar code scanners, the bar code reader and the bar code bar 72. As discussed above, the data from the bar code scanners is used to correlate the collected test data to a specific ID / AST panel 30. Each data accumulation cycle (i.e., a rotation of set 51), the control processor 70 expects to receive the data related to the bar code labels of each of the ID / AST panels 30 in set 51 and the test data for each panel 30 of ID / AST. If none is received, the control processor 70 determines that an ID / AST panel 30 is logically present at that panel location. However, if both types of data are not received, the control processor 70 discards the data for that accumulation cycle. Upon completion of a data accumulation cycle, the control processor 70 receives serial data from the detector microcontrollers 106. This data is stored in the memory. The control processor 70 then interprets the data from the ID wells 31 (ie, the wells associated with the ID portion of the ID / AST panels 30, as will be discussed below) to produce an identification of the organism. The control processor 70 also interprets the data from the AST wells 31 to produce either the MIC results or through the National Committees for guidelines of the Laboratory Standards (NCCLS), produces a Susceptible, Intermediate or Resistant result. (SIR) which refers to the point of disintegration for the AST categories. The final results for the ID / AST panels 30 are stored in the memory and can be downloaded to a diskette or floppy disk, for example, to preserve the storage space within the memory. Other functions carried out by the control processor 70 include communicating with externally connected network devices (eg a local area network (LAN) and the like), providing a printer port, performing bootstrap and self-diagnostic tests for ensure that the instrument 20 is functioning properly and generating the appropriate alarm signals. The control processor 70 also provides the operator with the graphical user interface (not shown) through the front panel 71 of the instrument, and accepts the user commands at the input through the keyboard 72.

Returning to Figures 3A-3C, the ID / AST panels 30 are supplied in a combination format. Each ID / AST panel 30 has reactive well positions capable of carrying out the ID / AST test on the same panel. As discussed above, ID / AST panels 30 include wells 31 and bar code labels. The wells 31 are separated into an ID section 33 and an AST section 34. The ID section 33 of the ID / AST panel 30 consists of 51 wells 31. The AST section 34 of the ID / AST panel 30 consists of 85 wells 31. For example, wells 31 of section 34 of AST may contain dried antibiotics therein. The ID / AST panels 30 also include a base 35, a chassis 36, a lid 37 and a pad 38 of cellulose acetate. Each ID / AST panel 30 also includes a panel tag (not shown) that includes information to identify the complete fabrication history of the specific ID / AST panel 30. The code bar label provides information related to the type of ID / AST panel and also has a unique number of sequences for identification purposes. The bar code label may be provided in code 128, the numerical format or any other appropriate bar code format. Each ID / AST panel 30 is inoculated with an organism suspended in broth before being placed in the instrument 20. In practice, the microorganism is a processed and resuspended dilution of the microbiological growth of the primary culture, which is either an ID inoculum fluid or an AST inoculum fluid that is then emptied into the test panel. The ID / AST panels 30 are inclined with the inoculation ports 39 in the upper part for filling. Manually separated inoculums are added to ports 39 of ID and AST. Each well 31 in the ID section 33 is inoculated with the ID inoculum fluid as the inoculum flows down the panel to the pad 38. Each well 31 in the AST section 34 is inoculated with the inoculum fluid of the inoculum. AST. The inoculum fluid down the ID / AST panel 30 in a serpentine manner filling the wells 31 as the front of the liquid advances towards the pad 38. Each well 31 is discharged allowing the liquid to fill the well 31. Each well 31 has a pronounced circular rim to separate an amount of compatible liquid from the excess and to isolate each well 31 from the liquid in the adjacent wells 31. The pad 38 absorbs the excess liquid. The ID / AST panels 30 are inoculated with the inoculum fluids at a panel inoculation station (not shown). Each station retains two tubes of the inoculum fluid (i.e., the ID inoculum fluid and the AST inoculum fluid) and supports an ID / AST panel 30. Gravity drives the inoculum fluids through the ID / AST panels 30. The ID inoculum fluid and the AST inoculum fluid comprises the reactive subsystem which includes all the reagents required to process the isolated bacterial colonies into inoculums prepared to be added to the ID section 33 and the AST section 34 of the panels. of ID / AST. The ID inoculum fluid is used for identification of the organism. A variety of ID inoculum fluids can be used even when a saline solution is preferred. A detergent may be added to improve the ID / AST panel 30 by filling the station of the panel inoculum. Preferably the density of the inoculum for inoculation of the ID panel is at least 1 x 10 cfu / ml. A variety of identification reagents can be used, including Phenol Red and Iodine-Nitro-Tetrazolium (INT). A variety of substrates can also be used which include those derived from a 4-methyl ether (4-MUU), the methyl-amino-coumarin derivatives (4-AMC), para-nitrophenol derivatives, and esculin. The AST inoculum fluid used for the determination of AST is a modified formulation of the - 5 - Mueller-Hinton broth. Preferably, the density of the inoculum for inoculation of the AST panel is at least 1 x 10 cfu / ml. Different inoculum densities may be used for other embodiments of the present invention, such as the "fast" AST test results. These are the AST test results obtained within sixteen hours of inoculation of the 30 ID / AST panel. A variety of AST indicators can be used. The preferred indicator for AST determinations in the present invention is alamarBlue ™ an oxidation reduction indicator stabilized with redox. The indicator is added to the AST inoculum fluid and mixed just before the addition to the sample of the microorganism to be tested by the instrument 20. As mentioned above, the control processor 70 interprets the data of the Wells 31 for the purpose of detection, identification and susceptibility testing. The control processor uses three variable threshold levels when interpreting this data: a dynamic threshold and a relative threshold. When the absolute threshold is used, a positive assessment made by determining whether the reading of the normalized well 31 is above (positive) or below (negative) a given predetermined value. When the dynamic threshold is used, a reaction determination of the reagent is calculated using first and second differences or mathematical manipulations for the detection of data related to the rate of change of the signal increase as a function of time determining when certain excesses have been exceeded. parameters of the first and / or second calculated differences. When the relative threshold is used, a determination of the reaction of the reagent is made by adjusting a predetermined percentage of the threshold above the level of the match signal of the well 31 in question. During the operation, the ID / AST panels 30 are mounted and incubated in the merry-go-round 50 of the instrument 20. As the visible light source assembly 80 and the ultraviolet light source assembly 81 are energized in sequence, take a reading that corresponds to the wavelengths of red, green, blue and fluorescent light. Based on the rotational speed of the merry-go-round 50, light intensity readings are taken at predetermined intervals by the optical measurement system 100. For example, when the merry-go-round 50 is driven by the driving system 56 at an angular speed of 2.0 revolutions per minute (RPM), a rotation of the merry-go-round 50 requires 30 seconds. In this way, to accumulate the data for red, green, blue and ultraviolet wavelengths, two minutes are required. Therefore in this example, a complete set of data can be taken by the present invention every two minutes. Since it is possible to vary the angular velocity, different angular velocity can be used for different tests. For example, it may be desirable to accumulate ultraviolet light data at 1.0 revolution per minute (while another test data is accumulated at 2.0 revolutions per minute). In this case, a complete data set would require two and a half minutes to complete. In the present invention, the results of the AST endpoint based on well readings 31 can be obtained after 18 to 24 hours of incubation. In an alternative modality, AST results can be obtained within 16 hours of panel inoculation. With respect to identification accuracy, the control processor 70 includes the ID database that includes more than 126 species for gram-negative organisms and 103 species for gram-positive organisms. The control processor 70 also includes the AST taxa database equivalent to the ID taxa database, for both gram-positive and gram-negative. For the purposes of AST testing, the present invention also includes a database with all the human and veterinary antimicrobial materials known today. Although the present invention has been described above in terms of specific embodiments, it should be understood that the invention is not intended to be limited or restricted to the embodiments disclosed herein. On the contrary, the present invention is intended to cover various methods, structures and modifications thereof, which are included within the spirit and scope of the appended claims.

Claims (43)

R E I V I ND I C A C I O N S

1. A microbiological diagnostic testing apparatus comprising: a roundabout assembly adapted to mount a plurality of test panels, each having a plurality of wells to receive a test inoculum fluid to produce a reaction; a plurality of light sources capable of directing light of predetermined wavelengths towards the wells of the test panels to cause the wells to emit or absorb light based on the reaction of the test inoculum fluid; a light detection unit positioned opposite the light sources, with at least one test panel being placed between the light sources and the light detection unit, the light detection unit for detecting the light emitted from, or absorbed by the wells of at least one test panel, wherein the merry-go-round assembly continuously rotates during the test to place each of the test panels between the light sources and the light detection unit in order to allow that the light emitted from, or absorbed by, the wells of the test panels is detected by the detection unit of - light as the test panels move beyond the light sources; and a controller adapted to receive a plurality of signals generated by the light detection unit, each signal corresponds respectively to the light detected from each well, the controller to determine a test result for each well based on the received signals.

2. An apparatus according to claim 1, wherein the inoculum fluid comprises one or more reagents and a microbiological test sample.

3. An apparatus according to claim 2, wherein the inoculum fluid produces a reaction to provide a result of the identification test.

4. An apparatus according to claim 2, wherein the inoculum fluid produces a reaction to provide a result of the antibiotic susceptibility test.

5. An apparatus according to claim 1, wherein the light sources are positioned to be close to each light panel that is rotated between the light sources and the light detection unit.

6. An apparatus according to claim 1, wherein the light detection unit includes a linear CCD array.

An apparatus according to claim 6, further comprising means for spatially averaging an analog linear CCD signal from the linear CCD array in order to eliminate unwanted optical and electrical artifacts from the sample column data of the linear CCD array .

8. An apparatus according to claim 7, wherein the means of averaging performs spatial averaging using partial analogue deconmutation of the pixel intensity of the analog linear CCD signal.

9. An apparatus according to claim 1, wherein the light detection unit includes a linear CCD array, the light sources are capable of selectively generating the monochromatic light and can be selectively energized to produce red, green or red light. wavelength blue, the merry-go-round set is also adapted to mount a normalization panel having a plurality of normalization wells, and the plurality of received signals includes a normalization signal generated by the unit - of light detection from the light emitted from, or absorbed by, the normalization wells of the normalization panel.

10. An apparatus according to claim 9, wherein the selectively energized monochromatic light provides linear illumination through a column of wells of the normalization panel or test panels.

11. An apparatus according to claim 10, further comprising a means for piecewise fitting along the column of wells in the normalization panel.

12. An apparatus according to claim 11, which further comprises a means for illuminating a column of the wells using the test panels an illumination profile, thus allowing an optical response of each well to be measured with uniform sensitivity for all well locations within each column .

An apparatus according to claim 1, wherein the merry-go-round assembly is also adapted to mount a normalization panel having a plurality of normalization wells, and the plurality of received signals includes a normalization signal generated by the unit of light detection from the light emitted from, or absorbed by, the normalization wells of the normalization panel.

14. An apparatus according to claim 13, wherein the controller normalizes the received signals corresponding to the wells of the test panels using the normalization signal.

15. An apparatus according to claim 1, further comprising a plurality of optical filters, each optical filter is placed between the test panels and the light detection unit to pass through it only the light emitted from, or absorbed, by wells having a predetermined bandwidth around a predetermined wavelength.

16. An apparatus according to claim 1, wherein the light sources include a first light source capable of selectively generating monochromatic light and a second light source capable of generating ultraviolet light.

An apparatus according to claim 16, wherein the first light source comprises a plurality of red light emitting diodes, a plurality of green light emitting diodes and a plurality of blue light emitting diodes, and each of the plurality of light emitting diodes is selectively energized.

18. An apparatus according to claim 16, wherein the first light source comprises a plurality of light emitting diodes placed in a predetermined manner.

An apparatus according to claim 18, wherein the plurality of light emitting diodes are placed in a column having an upper end and a lower end, and wherein the light emitting diodes are separated closer together in the upper and lower ends compared to the light emitting diodes in a central portion of the column.

20. An apparatus according to claim 1, wherein the light detection unit includes a linear detector array.

21. An apparatus according to claim 1, wherein at least one of the light sources is capable of selectively generating sufficient light to produce a fluorescence emission of the test inoculum fluid.

22. An apparatus according to claim 21, wherein the light source comprises a cold ultraviolet cathode lamp or a hot ultraviolet cathode lamp.

23. An apparatus according to claim 1, wherein each received signal corresponds to a numerical value indicating the detected light intensity of each respective well.

24. An apparatus according to claim 1, further comprising a bar code reading apparatus placed approximately on the test panels to read the bar code signals respectively affixed to the test panels.

25. An apparatus according to claim 1, wherein the control processor determines the test results using received colorimetric or fluorometric signals, or both.

26. An apparatus according to claim 1, further comprising an incubation unit for heating the test panels.

27. An apparatus according to claim 1, further comprising a shell surrounding the merry-go-round assembly to prevent detection of ambient light by the light detection unit.

28. An apparatus according to claim 1, wherein the merry-go-round assembly further comprises a carrier adapted to receive and carry the test panels.

29. An apparatus according to claim 1, wherein the wells of a test panel are placed in rows and columns, and where the light sources direct the light towards one of the columns of the wells.

30. An apparatus according to claim 6, wherein the wells of the test channel are placed in rows and columns, and wherein the linear CCD formation is placed to detect light from a column of wells through a predetermined number. of scans, with the linear CCD formation detecting a portion of the well column in each scan.

31. An apparatus according to claim 1, wherein the roundabout assembly further comprises a motor unit for rotating the roundabout assembly.

An apparatus according to claim 30, wherein the merry-go-round assembly further comprises a stepper motor unit for rotating the carousel assembly and the stepper speed motor causing the carousel assembly to rotate continuously during the proof.

33. An apparatus according to claim 1, wherein the test panels are capable of being mounted on the merry-go-round assembly.

34. A diagnostic microbiological test system comprising: a diagnostic microbiological test apparatus according to claim 1; a station for inoculating the test panels with the test inoculum fluid; a computer work station comprising: a CPU for further processing the performance of the test result of the microbiological diagnostic test apparatus to the computer workstation; and a memory for selectively storing the test result of the microbiological diagnostic test apparatus and the result of the test further processed.

35. An incubation chamber for a diagnostic microbiological testing apparatus, the chamber comprises: a merry-go-round assembly adapted to mount a plurality of test panels each having a plurality of wells to receive a test inoculum fluid to produce a test reaction; an enclosure surrounding the carousel assembly to prevent intrusion of ambient light into the incubation chamber, the enclosure having a door to provide access to the carousel assembly; an impeller system for continuously rotating the carousel assembly to directly place the test panels for testing by the microbiological diagnostic test apparatus; a heating unit for heating the incubation chamber; and a temperature controller for controlling the heating unit in order to maintain the temperature of the incubation chamber within a predetermined temperature range.

36. A camera according to claim 35, wherein the roundabout assembly further comprises a carrier adapted to receive and carry the test panels.

37. A camera according to claim 35, further comprising means for allowing the diagnostic microbiological test apparatus to determine a predetermined position of the merry-go-round set.

38. A carrier for a diagnostic microbiological test apparatus having a roundabout set, the carrier comprises: a frame adapted to receive and carry a test panel having a plurality of wells to receive a test inoculum fluid to produce a reaction , the frame receives the test panel in order to place the test panel in a predetermined manner; means for mounting the frame on the roundabout set; an electrical connection means for electrically connecting the carrier with the merry-go-round assembly; and a light emitting diode mounted on the frame and electrically connected to the electrical connection means, the light emitting diode is capable of being activated selectively by the diagnostic microbiological test apparatus.

39. A carrier according to claim 38, wherein the light emitting diode indicates that the test has been completed by the diagnostic microbiological test apparatus.

40. A carrier according to claim 38, further comprising means for allowing the diagnostic microbiological test apparatus to determine the leading edge of the test panel received therein.

41. A diagnostic microbiological testing apparatus comprising: a roundabout assembly adapted to mount a plurality of test panels, each having a plurality of wells to receive a test inoculum fluid to produce a reaction; at least one light source capable of directing light of a predetermined wavelength into the wells of the test panels to cause the wells to reflect or absorb light based on the reaction of the test inoculum fluid; a light detection unit placed at a reflection angle with respect to the light source, with at least one test panel being positioned opposite the light source and the light detection unit in a reflective manner, the light detecting unit for detecting light reflected from, or absorbed by, the wells of at least one panel, wherein the merry-go-round assembly continuously rotates during the test to place each of the test panels in order to allow light reflected from, or absorbed by, the wells of the test panels is detected by the light detection unit as the test panels move beyond the light source; and a controller adapted to receive a plurality of signals generated by the light detection unit, each signal corresponds respectively to the light detected from each well, the controller to determine a test result for each well based on the received signals.

42. A method for operating a diagnostic microbiological test apparatus comprising the steps of: continuously rotating a merry-go-round of the test apparatus to place a test panel between a light source and a light detection unit of the apparatus test, the test panel includes a plurality of wells to receive an inoculum fluid comprising a reagent and a microbiological test sample to produce a test reaction and which is mounted on the merry-go-round; direct light from the light source to at least one test panel; detecting within the light detecting unit the light emitted from, or absorbed by, each of the wells of at least one test panel due to the reaction of the test; generating with the light detection unit a signal corresponding to the light detected from each of the wells; and determining a test result for each of the wells based on the generated signal.

43. A method for carrying out the diagnostic microbiological test comprising the steps of: inoculating a plurality of test panels including a plurality of wells to receive an inoculum fluid comprising a reagent and a microbiological test sample to produce a test reaction; assemble the test panels in a roundabout of a diagnostic microbiological test apparatus; and operating the test apparatus to cause (1) the merry-go-round to rotate continuously in order to place at least one test panel between a light source and a light detection unit of the test apparatus, (2) a light from the light source to be directed towards at least one test panel, (3) the light emitted from, or absorbed by, each of the wells of at least one test panel due to the test reaction to be detected by the light detection unit, (4) a signal corresponding to the light detected from each of the wells to be generated by the light detection unit, and (5) a result of the test to be determined for each of the wells based on the generated signal. Four . A computer-readable medium on which instructions are stored, which during execution will operate a microbiological diagnostic test apparatus, the instructions comprise: instructions for continuously rotating a merry-go-round of the test apparatus to place at least one test panel between a light source and a light detection unit of the test apparatus, the test panel includes a plurality of wells to receive a fluid from the inoculum comprising a reagent and a microbiological test sample to produce a test reaction and which is ride on the merry-go-round; instructions for activating the light from the light source in order to illuminate at least one test panel; instructions for detecting with the light detection unit the light emitted from or absorbed by each of the wells of at least one test panel due to the test reaction; the instructions to generate with the light detection unit a signal corresponding to the detected light of each of the wells; and the instructions to determine a test result for each of the wells based on the generated signal. 45. A computer-readable medium in which instructions are stored, which during operation will operate the microbiological diagnostic test apparatus, the instructions comprise: instructions for controlling the rotation speed of a carousel of the prudent apparatus to move continuously so After a test panel and at least one normalizing panel beyond a light source and a light detection unit of the test apparatus, at a predetermined angular velocity, the test panel includes a plurality of wells to receive a fluid of the inoculum comprising a reagent and a microbiological test sample to produce a test reaction and which are mounted on the merry-go-round, the normalizing panel includes a plurality of normalization wells; instructions for detecting with the light detection unit, the light emitted from, or absorbed by, each of the normalization wells of at least one normalizing panel; instructions for normalizing the light emitted from, or absorbed by, each of the wells of at least one test panel due to the test reaction and detected in the light detection unit; the instructions for generating with the light detection unit a signal corresponding to the normalized light from each of the wells; and instructions for determining a test result for each of the wells based on the generated signal. 46. A computer readable medium according to claim 45, the instructions further comprise: instructions for monitoring an intensity of light, from the light of the directed light source towards at least one test panel; and instructions for taking corrective action if the intensity of the light falls outside a predetermined scale. 47. An apparatus comprising: a light source capable of producing a composite light signal having light elements of varying intensity; and a controller adapted to control the light source using a lighting profile. 48. An apparatus according to claim 47, further comprising: a light detecting unit; and an optical system capable of directing the composite light signal to the light detection unit. 49. An apparatus according to claim 48, wherein the illumination profile corrects the optical inefficiency in the optical system. 50. An apparatus according to claim 47, wherein the light source comprises a plurality of light emitting diodes that are positioned as a linear array. 51. An apparatus according to claim 47, further comprising a sensor electrically connected to the controller, wherein the sensor monitors the light signal and the controller controls the light source in response to a signal from the sensor. 52. An apparatus according to claim 47, further comprising a feedback means for providing feedback to the controller, wherein the controller compensates for undesirable changes in signal light composed by selecting a profile of the plurality of lighting profiles. 53. A light source comprising: a plurality of light emitting diodes which are placed in a linear array, the current board of each light emitting diode being controllable to produce a predetermined illumination profile. 54. A light source comprising: a plurality of light emitting diodes which are placed in a linear array having two ends, each end has a group of light emitting diodes of the plurality of light emitting diodes, each group light-emitting diodes being geometrically compressed. 55. A light source according to claim 54, wherein the light emitting diodes comprise red, green and blue emitting diodes placed in a predetermined order in the linear array. 56. An optical system that includes a test panel that has a plurality of wells, each well to receive a test inoculum fluid, the system comprises: a visible light source capable of producing light of different wavelengths; a diffuser placed between the visible light source and the test panel; a source of ultraviolet light; an excitation filter positioned between the UV light source and the test panel where light and ultraviolet light cause the wells to emit or absorb light based on the reaction of test fluid test inoculum; an emission filter placed between the test panel and an objective lens to filter the ultraviolet light from the light emitted, from, or absorbed by, the wells; and the objective lens is placed between the emission filter and a detector, the objective lens focusing the filtered, emitted or absorbed light towards the detector.