Abstract:
The present invention relates to a hand-held diagnostic testing system and method employing apparatus that can effect a chemiluminescent reaction and record the same on photographic film.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of Provisional Application No. 60/104,150, filed Oct. 14, 1998. 
     The present invention U.S. non-provisional patent application, Ser. No. 09/412,845, entitled “Diagnostic Assay System and Method; filed on Oct. 6, 1999, now U.S. Pat. No. 6,331,715. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates generally to diagnostic assay systems and methods capable for multiple samples in a simple and reliable manner. 
     A wide variety of systems and approaches exist which allow the occurrence and recording of luminescent reactions, such as of the chemiluminescent, or fluorescent type for qualitative and quantitative results. One class of analytical instruments typically used in this field is referred to as luminometers. Luminometers conduct and record luminescent reactions generated, for instance, by a biological test fluid sample that contains a reagent of interest, such as an analyte, and a reagent in an assay element. Examples of these approaches include single-sample luminometers fitted with photographic multipliers; single-sample luminometers fitted with solid-state detectors; multiple sample luminometers; automatic luminometers with imaging systems based on CCD cameras; and photographic camera type luminometers. Some of the foregoing devices using photographic films of the conventional and self-developing type for recording luminescent activity are described in, for example, in U.S. Pat. Nos. 4,863,689; 5,035,866; and 5,188,965. Heretofore known prior art, tends to be limited in a number of ways, such as being expensive due to the expensive electronics required, training of personnel required because of their relatively complicated nature, and being relatively cumbersome in use and expensive in construction. 
     Despite the existence of a wide variety of known diagnostic luminescent type testing systems and approaches, however, it is, nevertheless, desired to improve upon the overall ease, versatility, and reliability of such systems and their testing procedures, as well as reduce overall costs associated with their construction and use. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention, one provision is, preferably, made for a hand-held, portable diagnostic assay system. The system is operable for conducting and recording luminescent reactions, that generate luminescent signals, such as chemiluminescent and fluorescent signals, that are recordable an image recording medium, such as a film assemblage of the self-developing type. Included in the system, in one embodiment, is a housing assembly defining a light-tight enclosure carrying at least the film unit and an exposure opening that optically communicates the film unit and the luminescent read-out signal. A film processing unit in the housing is operable for processing exposed self-developing film units passing therethrough. Provision is made for a sample carrier means or assembly that has one condition for receiving a luminescent testing assembly and a second condition for exposing the film. The sample carrier assembly can carry, in a light-tight manner, at least one luminescent testing assembly that is capable of generating a luminescent read-out signal recordable on the image recording medium in response to the testing assembly being actuated. Whenever the sample carrier is in the second condition, the generated signal exposes the film unit. Developing the resultant latent image is initiated when the film unit is advanced from the housing after passing through the film processing unit. 
     In an illustrated preferred embodiment, the sample carrier has an opening for receiving a test container of the luminescent testing assembly. The test container comprises a reservoir that stores a luminescent testing means; which in a preferred embodiment is in the form of a fluid that is sealed by means of a sealing device. A portion of the reservoir is transparent for allowing transmission of the generated read-out signal to the film through an open exposure opening. A sampling device of the luminescent testing assembly can sample a surface to be tested and is inserted, in a light-tight manner, within the test container such that a portion thereof is immersed in the fluid. If the sampling device contains a reagent that reacts with a reagent in the assay fluid, the generated luminescent signal can expose the film through the open exposure opening and transparent portion. In this embodiment, movement of the sample carrier carrying the luminescent testing assembly opens the exposure opening and registers the transparent reservoir portion therewith for exposing the film. Movement of the sample carrier back to the receiving position closes the exposure opening. Further in another illustrated embodiment, the test container includes opaque means therein which serves, when the container is held in the sample carrier, to block ambient light from reaching the exposure opening. 
     In another illustrated preferred embodiment, provision is made for effecting and recording a luminescent read-out signal of a control test generally simultaneously with a luminescent signal of the test sample. 
     In an illustrated embodiment, a sample carrier assembly carries a luminescent sample test assembly and a luminescent control test assembly. Fluid transfer means, such as light-tight capillary grooves, allow transfer of the control and test fluids from separate ports therefor to the respective test assemblies. When the sample carrier is inserted into a recess in a processor housing containing the film, a shuttering mechanism is opened which allows luminescent read-out signals emitted from the test sample and control luminescent testing assemblies to respectively expose the film. Removal of the sample carrier from the processor housing closes the shutter. The film can be advanced as indicated above in the other embodiments. 
     In still another illustrated embodiment of the present invention, provision is made for a means and method for achieving a quantification of the luminescent signal generated and recorded on the film. In one such embodiment, such quantification is achieved by reason of an optical filter. The filter can have alternating light attenuating zones, such as transparent and opaque zones that act to delineate different sized read-out signals. The different sized images correlate to corresponding different test results. Because of the light attenuation, different sized luminescent images will be visible through correspondingly different sized attenuation zones; thereby providing a visual measurement of the test results. In yet other embodiments, the quantification can be obtained by pre-exposing the film with a gradation of different sized images. The different sizes correspond to different predetermined outputs of the luminescent signals. Alternately, provision is for a film overlay comprising a series of different sized images thereon with each overlay image corresponding to different test outputs. In use the test image that is captured during the actual test can be compared to images on the overlay for quantifying the test result. 
     Methods are contemplated for conducting and recording read-out signals that can expose the image recording material. 
     It is an object of the present invention to provide an improved method and system for conducting and recording luminescent reactions, wherein the results can be immediately and reliably ascertained by an operator. 
     It is another object of the present invention to provide an improved method and system for conducting and recording luminescent reactions in a hand-held assay processor using self-developing type film. 
     It is another object of the present invention to provide an improved method and system of the last noted types for conducting and recording multiple sample tests. 
     It is another object of the present invention to provide an improved method and system for conducting and recording luminescent reactions in a hand-held assay processor wherein both test sample and control fluids are applied to corresponding different test strips. 
     It is another object of the present invention to provide an improved method and system of the last noted types for conducting and recording luminescent reactions wherein the output signals are recorded on film and quantified. 
     It is another object of the present invention to detect the luminescent signals electronically and print relevant information on the film. 
     It is another object of the present invention to provide for an improved method and system which is simple and reliable to operate and which is low-cost in cost. 
     The above and other objects and features of the present invention will become apparent when reading the following description taken conjunction with the accompanying drawings wherein like parts are indicated by like reference numerals throughout the several views. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an exploded perspective schematic view illustrating several components forming one embodiment of a multiple sample diagnostic assay system of the present invention; 
     FIG. 1A is an enlarged and fragmented schematic view of a film assemblage that can be used in connection with the invention; 
     FIG. 2 is a schematic exploded perspective view illustrating components of the assay system; 
     FIG. 3 is a bottom plan view of a sample carrier component of the assay system; 
     FIG. 4 is a bottom plan view of alternate embodiment of a sample carrier; 
     FIG. 5 is a view of an alternate embodiment of a diagnostic assay system of the present invention; 
     FIG. 6 is an enlarged schematic view of the interaction between the a sample carrier and a shutter mechanism; 
     FIG. 7 is a plan view of an optical filtering arrangement for use in the diagnostic assay systems; 
     FIG. 8 is a plan view of another embodiment of an filtering arrangement; 
     FIG. 9 is a schematic view of yet another preferred embodiment of a processor of the present invention; and, 
     FIG. 10 is a cross-sectional view of a test container usable in the processor of FIG.  9 . 
    
    
     DETAILED DESCRIPTION 
     Reference is made to FIGS. 1-3 for schematically illustrating one of the preferred embodiments of a multiple sample diagnostic assay system  10 . The diagnostic assay  10  includes a light-tight, processor housing assembly  12  having the general configuration depictedu and containing therewithin a film box  14 . Contained in light-tight relationship to the film box  14  is a film assemblage  16 . 
     The preferred embodiment of the film assemblage  16  is similar to that described in copending and commonly assigned U.S. patent applications Ser. No. 08/738,772; and Ser. No. 08/829,914 a description thereof is incorporated herein and made a part hereof. Since the construction of the film assemblage does not, per se, form and aspect of the present invention, only those details of such a film assemblage needed for describing the present invention will be set forth. Details of such a construction are set forth in the aforenoted copending patent application. Basically, the film assemblage  16  includes an elongated strip  18  comprising a plurality of self-developing film units  20  secured end-to-end to connection strips in alternating arrangement to form a longitudinal strip. Weakened portions in the connection strips are structurally weakened to permit easy separation in a manner to be described. Each of the film units is, preferably, of the integral self-developing integral type. In this connection, each of the film units  20  includes a tab or leader portion  20   a , an image recording area  20   b , a pod  20   c  of processing fluid located at a leading end portion, and a fluid trap  20   d  at a trailing end. The photosensitive image recording area  20   b  is positioned within the housing assembly so as to be exposed to a read-out signal of a luminescent activity. Luminescent activity or read-out as used in this specification includes any luminescent activity such as of the chemiluminescent type, fluorescence, infrared and other signals that are recordable on an image recording material. The pod  20   c  is positioned adjacent the processing means, as will be described and a tab or leader portion  20   a  of the leading film unit protrudes from a film exit  24  in the device so that the film unit may be manually grasped for pulling and processing of the film unit as will be described. The film exit  24  is appropriately provided with flaps (not shown) or the like for providing a light-tight enclosure. 
     In the illustrated embodiment, the processor housing assembly  12  includes a pair of generally rectangular and matable lower and upper plate-like processor housing portions  26  and  28 . The housing portions are hingedly connected as at  29  to permit loading of the film box within a complementary shaped compartment within the processor. The housing assembly  12  is, preferably, dimensioned to be hand-held and portable for providing a self-contained and portable diagnostic assay system that is convenient to use. The housing portions  26  and  28  can be made of any material suitable to define, preferably, a light-tight enclosure  32 . While a hinged coupling is described, a wide variety of approaches for joining the two opposed housing components are envisioned. The lower processor housing portion  26  is similar in construction to that described in the last-noted application and basically includes a film supporting wall (not shown) a processing fluid spreading structure  30  (not shown) for spreading the processing fluid ruptured from the pod in a well-known manner. A lower spread roller  34  is rotatably supported in the lower housing portion for cooperating with a biased upper spread roller  36  in the upper housing portion  28  to define a pressure nip. The rollers  34  and  36  serve to rupture the pod and spread the processing fluid as a film unit passes therethrough. In addition, the nip acts to inexpensively retain the film assemblage  16  within the housing prior to use of the device. Accordingly, the film can be transported and handled without fear of it becoming dislodged or otherwise separated. 
     The upper housing  28  includes a generally rectangular recess  40  that has pivotally mounted thereon, as at  42 , a shutter blade  44 . The shutter blade  44  moves between light blocking and unblocking relationships relative to an exposure opening  48  that is in optical communication with an image portion of a film unit. A light-seal plate  50  has a construction as shown to be mounted in and suitably secured to reside within the recess of the upper housing and includes an aperture  52 . The plate  50  serves to rotatably mount, within the aperture  52  a rotatable test sample carrier  54 . The test sample carrier  54  has a generally cylindrical configuration with a reduced diameter portion that has a snug, light-tight fit within the plate. The test sample carrier  54  includes a passage  56  extending longitudinally therethrough. A plurality of linearly spaced apart stepped shoulders  58   a ,  58   b  are provided in the passageway for supporting a test sample device. A pair of arcuately spaced apart and downwardly protruding opening and closing pins  60  and  62 ; respectively, on the test sample carrier alternately engage the shutter to open and closed positions as the carrier is rotated in opposite directions; in a manner to be described. In this embodiment, the sample carrier can be manually grasped about its periphery and turned in either direction. Of course, manual means, such as handles or motorized means can be used to rotate the sample carrier. 
     The device  10  is adapted for particular use in connection with a luminescent assay testing assembly  63  that includes an ampoule  64  and a test sample pick-up device  66  that is housed and cooperates with the ampoule in a manner to be described. It will be understood, however, that the test system to be described is but one of several which can be used in conjunction with the device. In the illustrated embodiment, the luminescent testing assay assembly including the ampoule, fluid, and pick-up device are similar to that commercially available from Biotrace, Inc., Plainsboro, N.J. It will be understood that the device of the present invention can be used in connection with other similar diagnostic systems. The ampoule  64  includes a generally hollow tubular housing for slidably receiving the pick-up device  66 . Preferably, the housing is made of transparent plastic, and has an open end portion  68  that is adapted to receive the sample pick-up, and a closed end portion  70 . While the present embodiment of the ampoule includes a transparent housing, it will be appreciated that need not be the case. In the latter regard, however, the closed end portion should be transparent in order to transmit any luminescent activity; whereby the latter can form a latent image on the film. A sealing membrane  72  is located generally transversely to the housing  67  so as to define a chamber or reservoir  74  with the closed end portion in order to sealingly accommodate an assay fluid  76 . The sealing membrane  72  is made of a thin-walled metallic material that is impervious to fluid and ambient atmosphere. The sealing membrane is adapted to be punctured by the sample pick-up device  66 ; when the latter is inserted therethrough. The assay fluid  76  can be one that generates a chemiluminescent signal in response to a reagent, such as ATP (Adenosine Triphosphate) being present on the sampling rings. ATP is used as an indicator of the presence of organic debris, such as microorganisms. The fluid  76  can be, for example, a Firefly reagent which generates a light signal in response to ATP collected on the sampling device  66 . The sample pick-up device includes a handle  78 , a stem  80  and a plurality of laterally extending sampling rings  82 . The sampling rings  82  are used to engage a surface to be tested for micoroganisms. A user merely rubs the rings against a surface to be tested, for instance, a food preparation surface and inserts the sampling ring into and through the membrane, whereupon the rings are immersed into the assay fluid. If ATP is present, in significant amounts on the sampling rings, it will react with the reagent in the fluid and generate a luminescent read-out signal that is recordable on the film. It is, of course, realized that the present invention contemplates use of a wide variety of fluids, membranes and sample pick-ups. The foregoing materials provide, but one of many that can be used in the context of the present invention. 
     Reference is made in particular to FIG. 2, wherein the luminescent testing assembly  63  is provided with an opaque means in the form of a plastic collar  86  being formed in combination with a segmented the tubular housing  67 . The plastic collar  86  has a central axially extending passageway  87  through which the sample pick-up  66  is inserted. An upper end portion  88  is fit within a central passage of upper tubular portion  67   a  and a lower end portion  90  is fit within a lower portion  67   b  of the housing above the sealing membrane. A projecting rim  92  extends radially from the collar and is adapted to rest on the shoulder  67   a.    
     In operation, a user can, for example, wipe the sampling rings on a surface to be tested for the presence of ATP. The ampoule housing  67  is placed within the passage  56  with the shoulder  58   b  being engaged by the collar rim  92  and the shoulder  58   a  engaging a surface  67   c  of the housing wherein the transparent closed end portion enters a reduced diameter portion of the passage  56 , whereby the ampoule is in an upstanding position with respect to the sample carrier. 
     Prior to testing, the sample carrier is in a non-exposing mode, whereby the passage  56  is circumferentially spaced from the aperture and the shutter blade is in the closed condition. To commence testing, the user inserts the test sample device  66  through the membrane so that the sampling rings are immersed within the assay fluid to initiate a chemiluminescent reaction, if the test ATP reacts with the reagent in the assay fluid; after a preselected time interval. The time interval, of course, varies as a function of several factors not relevant to the present invention. Timing such intervals is accomplished by means of a suitable timer  95  mounted on the device in any appropriate fashion and in exposing relationship (not shown) to the film unit. For example, the timer can be started when the sampling rings are immersed into the assay fluid. Following the prescribed time period for generating luminescent reactions, as indicated by the timing device, the sample carrier is rotated to the film exposing position. During rotation, the opening pin engages the shutter and drives the latter to its unblocking condition, while the closing pin correspondingly disengages the shutter; whereby the film aperture is opened so that the film can be exposed. It will be understood that displacement stops (not shown) for controlling displacement of the sample carrier can be appropriately provided. Accordingly, the film can be exposed by luminescent activity, assuming one, of course, occurs. The time interval for such an exposure can vary upon several factors including the speed of the film. Actuation of the timer  100  can occur manually or even automatically as, for example, in response to movement of the sample carrier by carrier drive means (not shown). The present invention envisions the use of film printable devices, such as LED&#39;s (not shown) that would be attached to the housing and otherwise actuatable to record desired information. 
     To process the latent luminescent images on the film, the film tab is pulled, whereby the film unit emerges from the housing through the processing rollers. As a result thereof, processing of the film units is initiated. Because of the frangible connection between each of the units, the unit pulled from the device separates and the next successive film unit is indexed to the exposure position for another test as a result of the pulling action on the strip. For instance, the test will indicate either a positive or negative result in a manner that is quickly and easily ascertained. The result is simple to read and understand and is one that does not require user interpretation, such as determining the color of a test result or calculating any quantification. It will be appreciated that as a consequence, a safe and simple diagnostic test is performed that provides a positive record of the test being conducted. Such testing is of particular benefit, particularly in the home testing market wherein it can be used for a variety of diagnostic tests with a certainty of results and a significant ease of operation. 
     As shown in FIG. 3, the sample carrier barrel need not have the opening and closing pins acting in cooperation with a shutter and, in fact, does not cooperate with a shutter. Rather, the sample carrier barrel, in effect, acts as a shutter. Towards this particular end, a bottom surface of the barrel is covered by a light-blocking material  98  that has a low-coefficient of friction, such as felt. While felt is disclosed in this embodiment, the present invention envisions a variety of materials that can be used in an equivalent manner. An opening in the felt is coincident with the passage  56 . The felt or other similar materials provide obviate the need for a shutter and shutter actuating mechanism. In addition, the present invention contemplates the use of a solenoid actuated shutter that would be operated by a suitable energizing means and provide somewhat greater control over the shuttering functions. 
     Reference is made to FIGS. 4 and 5 for illustrating another preferred embodiment of a multiple-sample processor  100  made according to the present invention. Structure of this embodiment similar to that of the previous embodiment will be indicated by like reference numerals with the addition of a prime mark. The sample processor  100  includes a housing assembly  102  and a sample carrier assembly  104  that are cooperable with each other in a manner to be described. Included in the housing are generally rectangular and matable lower and upper processor portions  106  and  108  which form a light-tight enclosure for housing a film assemblage  20 ′ like that described last-noted embodiment. Accordingly, a leading one of the film units is in a position for exposure within the housing and its tab  20   a  protrudes. The housing portions are hingedly connected as at  112  to permit loading of a film box  114  that is loadable within a complementary shaped compartment within the housing. The housing assembly  102  is, preferably, dimensioned to be hand-held and portable for convenient use in the field. The housing portions are made of any material suitable to define, preferably, a light-tight enclosure. While a hinged coupling is described, a wide variety of approaches for joining the two opposed housing components are envisioned. The lower processor housing portion  106  is similar in construction to that described in the last-noted application. Basically, it includes a film supporting wall (not shown) a processing fluid spreading structure  30 ′ (not shown) for spreading the processing fluid ruptured from the pod in a well-known manner. A lower spread roller  34 ′ is rotatably supported in the lower housing portion for cooperating with a biased upper spread roller  36 ′ in the upper housing portion  28  to define a pressure nip. The spread rollers serve to rupture the pod and spread the processing fluid. In addition, the nip thereof acts to inexpensively retain the film assemblage within the housing prior to use of the device. Accordingly, the film can be transported and handled without fear of it becoming dislodged or otherwise separated. 
     The upper housing  108  has a generally parallelepiped construction with a generally rectangular recess  120  and houses generally a pivoting shutter plate  122  having a pair of light blocking arms  124  and  126  that are selectively movable with respect to openings  128  and  130  in the bottom of the well. The shutter plate  122  is resiliently biased by a spring  123  to a solid line position with respect to the housing so as to be in a light-blocking relationship to the film whereby, the film openings  128 ,  130  are not in registry with the openings  148  and  148 ′; respectively. The shutter plate is movable to a light-unblocking relationship when the carrier is inserted within the processor so that the openings  128  and  130  will be in registry with the openings  148  and  148 ′; as will be described. 
     The sample carrier assembly  104  includes an elongate handle portion  132 , an assay holder tray  134 , for holding assay test strips  136 ,  136 ′, a tray cover  137 , and a tab guide  138 . The holder tray  134  and cover are removably held within a recess formed in the handle  132  and held by means of a frictional fit or other suitable means. In this embodiment, the upper surface of the tray includes, preferably, a pair of molded grooved arrangements  140 ,  140 ′. The molded grooved arrangement  140  is for the test sample and the arrangement  140 ′ is for allowing the performance of a control test being conducted with the test sample. Each one of which defines a generally rectangular test strip receiving well  142 ,  142 ′. Since both grooved arrangements are identical in construction, only the structure of one will be described. The receiving well  142  is in fluid communication with a capillary type fluid delivery channel  144  that is, in turn, in fluid communication with test fluid reservoir  146 . The reservoir  146  is for receiving a biological test fluid introduced therein by any suitable means, such as a pipette; not forming a part of this invention. A light transmitting aperture  148  in the well  142  is in optical registry with the opening  128  and thus with the image recording area of the film when the shutter blade is in its exposing position. Movement of the shutter blade to its opening position occurs in response to the tray engaging a resiliently bendable tab  125  (FIG. 5) as the tray is inserted into a rectangular opening  150  formed in a side of the housing assembly and overcoming the bias of the spring. The test strip  136  is a suitably dimensioned chemiluminescent testing assembly or assay test strip for interacting with a preselected reagent, such as an analyte. The analyte is carried in a biological fluid test sample that is delivered to the reservoir and from the reservoir via the fluid delivery channel  144  to the test strip. The test strip can be constructed from any of a wide variety of materials so long as it generates a luminescent signal capable of being recorded on film in response to interacting with a reagent carried in the test fluid. The capillary delivery channel  144  is comprised of a labyrinth grooved construction that is molded in the upper surface and serves to transfer the test fluid sample in a light-tight relationship from the reservoir to the well by virtue of capillary action. Therefore, it will be appreciated that the delivery channel  144  is constructed and dimensioned to induce or allow capillary action to transfer the test fluid from the reservoir to the well. In this embodiment, the walls defining the delivery channel  144  have a depth in the order of about 0.005 inch to 0.0024 inch in order to transfer the fluid by virtue of capillary action. The fluid reservoir  146  is of sufficient size to accommodate the quantity of test fluid to be deposited therein and, as noted, is in fluid communication with the channel  144 . The cover  137  is generally rectangular and has a fluid reservoir opening  156  in covering relationship to the grooved arrangements  140 , while a fluid port  158  is in communication with the grooved arrangement  140 ′ for delivering the control fluid. The control fluid will yield a chemiluminescent response with the assay strip  136 ′. 
     The cover  137  is suitably joined, as by heat bonding or ultrasonic welding to the tray. The fluid opening  156  is in direct fluid communication with the reservoir  146  for allowing delivery of the test fluid, as by a pipette, to the reservoir. The cover  137  can, if desired, be removably joined to the upper housing portion should it be so desired. In addition to the capillary action provided by the channels, the present invention contemplates that use of a wicking device made of suitable material (not shown) that can be added to the channels  144 ,  144 ′ to assist in transferring the test fluid. It is equally clear that the present invention envisions substituting a wicking system for the capillary channel itself. While one particular molded arrangement is illustrated for effecting the capillary flow, a wide variety of configurations and dimensions can be used for transferring the fluid. It is further envisioned that other than liquid actuated systems are contemplated, such as gaseous mediums. The tab guide  138  includes two spaced apart semi-circular parts that are adapted to surround the protruding tab  20   a  so as to inhibit the user pulling on the film unit until exposure is complete as determined by the type of chemiluminescent reaction occurring. Of course, suitable timing and/or printing mechanisms can be provided either in an integrated fashion with the device or separate therefrom. Removal of the test sample carrier allows the user to pull on the tab and commence processing of the latent image(s) on the film. Also the shutter returns to the light blocking condition and the tab  20   a  returns to a position which allows it to be engaged by the tray. 
     After explaining the construction, the operation thereof is self-evident. However, the following brief description of the operation is provided as a supplement. An operator introduces a test fluid sample through the reservoir opening  156 , as by a pipette, into the reservoir. The test fluid sample is transferred by reason of the capillary action induced by the capillary channel  144  to the test strip. If the test fluid contains the analyte being tested for, a chemiluminescent reaction occurs after a prescribed period of time. This generated signal transmitted to the film through the aligned openings  148 ,  128 ,  124  for effecting exposure. As long as the carrier remains inserted, a light-tight condition exists for proper exposure. 
     In order to process the latent image, the protruding tab  20  is pulled after the noted prescribed period of time, for example sixty (60) seconds. As noted, the pressure applying rollers rupture the pod and spread the fluid to develop any latent image generated by the chemiluminesence. Although a pair of a test strips is shown, additional tests with additional assay strips can be provided. 
     FIGS. 6 and 7 schematically depict use of an optical filtering arrangements  180 ,  182 ; respectively, for quantifying the results of the luminescent signals that are provided. In this embodiment, the filtering arrangement  180  comprises a flat filtering disk adapted to be positioned under the exposure aperture and is operable, in combination with the generated luminescent signals, for showing different light values on the film. In this embodiment, provision is made for three neutral density filters  186 ,  188  and  190  arranged as depicted that are separated and have decreasing transmissivity (e.g., 1 or 2 stops) characteristics to the light. Filter  186  is selected to allow the most light to the film and the filters  188  and  190  are graduated to require increasingly higher light levels to pass on the film. It will be appreciated that the higher the light level generated the greater the chemiluminescent activity is produced. Thus, the size of the chemiluminescent image will be proportional to the intensity of the reaction. In this manner, the chemiluminescent activity can be quantified by its size to indicate, for example, the degree to which a surface is contaminated by microorganisms. 
     FIG. 7 depicts another embodiment of an optical filtering arrangement  182  that is particularly adapted for use as an overlay to the film that is being exposed. The filter includes a transmissive center  192 , an opaque ring  194 , a transparent ring  196  with indicia  198  thereon in combination with the devices of the present invention. The filter inclues when compared to the alternating transparent rings  184 ,  186  and filtered rings  188 ,  190 . Indicia  192 , such as the term “positive” can be printed on the transparent rings, so as to assist the user in proper assessment of the test results. In this embodiment, the filter rings can be made neutral density filters that have light attenuating characteristics in the order of about one (1) or two (2) stops. The light attenuating characteristics can, of course, vary depending on the amount of light that is anticipated to be generated. Thus, if a relatively small spot is generated and appears visible only through the center only, such might be indicative of test results that are inconclusive; thereby requiring the performance of additional tests. If of course, no signal is generated, then the test is negative. If there is a sufficient signal, it will generate a spot visible through the transparent ring. While the foregoing embodiment discloses use of neutral density filters, the present invention is not so limited and encompasses other optical filtering arrangements. Although not shown, the present invention contemplates having the film pre-exposed with images, such as spots, having different sizes. The sizes would generally correlate to the size of spots that would be produced by luminescent signals indicative of, for example, the intensity of the ATP reaction in a test sample. This would assist in the quantificaion of test outputs. Alternatively, an overlay (not shown) could be placed over the film with, for example, the same type of spot gradation in order to compare the test signal exposure spot with these pre-exposed spots in order to assist in the quantification of the resultant luminescent signal. 
     FIG. 8 illustrates schematically another embodiment of the versatile, hand-held assay system  200 . In this version, however, the luminescent read-out signal of the ampoule, for example, is read by any suitable solid-state photodetector, such as a CCD  202 . The exposure of the CCD is under the control of a shutter mechanism  201 , which may be of the electromagnetic type. The CCD  202  is placed beneath the ampoule and in registration to the exposure aperture and is operably connected to a print driver in print head controller  204  that drives a light source in a light-tight enclosure; such as a plurality of LED&#39;s  206 . Operation of the LED&#39;s  206  exposes a film units of a film assemblage  16 . The LED&#39;s for instance, can be illuminated to provide qualitative and quantitative information which is sensed from the CCD  202 . For example, LED patterns indicative of the relative strength of the luminescent signal can be printed on the film. The exposed film unit is processed as indicated previously. Other light and image forming sources can be used, such as LCD&#39;s or vacuum florescent tubes for printing a variety of information. Also, other control devices, such as a microprocessor can be used in a variety of ways. 
     FIGS. 9 and 10 illustrate yet another preferred embodiment of the present invention. FIG. 9 illustrates a processor  300  which includes a light-tight housing  302  having an open top end  304  in which is rotatable a barrel  306  similar to that which is described in the first embodiment. This version is rotatable, preferably manually, about vertical axis  308 . The barrel  306  includes a plurality of openings  310 , one of which is illustrated. Each of the openings  310  is adapted to removably receive a generally cylindrical test container assembly  312 . The test container  312  comprises in essence to lower and upper reservoirs  314  and  316 ; respectively. The reservoirs are made of a suitable material such as plastic. The reservoir  314  includes a transparent cylindrical closed end wall  318  that allows the luminescent signal to pass therethrough and expose the film through the bottom opening of the barrel. The reservoir  314  includes a mounting flange  320  that is adapted to seat against complementary structure (not shown) within an opening  310 . A penetrable sealing membrane  322  made of a suitable material such as described above covers the open end of the reservoir  314 . A luminescent testing fluid  324  is sealingly housed in the lower reservoir  314 . 
     The upper reservoir  316  has a cylindrical configuration with an open end that is threadedly fastened as at  326  to the exterior surface of the open end of the lower reservoir  314 . An actuator member  328  protrudes from one end of the upper reservoir  316  and is adapted to be slidable within an end plug  330 . The upper reservoir  316  holds a fluid  332  capable of mixing with an analyte of interest obtained through sampling in a manner to be described. The actuator member  328  is adapted to be urged into the reservoir, as when the cover  335  closes the upper end of the housing  302  so that its tip will penetrate the membrane  322 . This action thereby allows the fluid  322  that has been mixed with the analyte of interest to flow by gravity into the reservoir  314  wherein they react with the testing fluid  324 . Consequently, should a chemiluminescent reaction occur it will be transmitted through the opening to the film or any other suitable image recording assembly, such as a CCD. 
     In use, an operator would separate the reservoirs by unfastening them. The operator would after taking a test sample, such as by swabbing a patient&#39;s throat insert the swab into the fluid contained in the upper reservoir and then reconnect the two reservoirs. A test container would be inserted into one of the openings  310  in the barrel  302 , so that the transparent wall  318  is seated in close proximity to the bottom of the barrel. The barrel is rotated so that the bottom of each of the respective openings  310  is in registry with a corresponding aperture (not shown) in the bottom wall of the housing. The apertures are in optical communication with the film; which is preferably of the self-developing type. As noted there is a light-tight relationship between the barrel and the housing apertures. When the cover  335  is closed it drives the actuator  328  downwardly sufficiently to penetrate the membrane  322 . This allows the fluid in the upper reservoir to mix with the fluid  324  in the lower reservoir for commencing a chemiluminescent reaction. Closing of the cover  335  can also serve to prevent removal of the film through any suitable interlock (not shown) with a film advancing system not shown but well-known in the field of processing self-developing film units. It will be appreciated that motor controls can be provided to this system for rotating the barrel. The barrel when rotated can actuate a switch to in turn actuate a locking device (not shown) that locks the cover and or barrel in place thereby preventing premature removal of the test container or movement of the barrel. As noted a suitable interlock can prevent premature withdrawal of the film until a predetermined time has elapsed. 
     Although the foregoing invention has been described in some detail, it will be readily apparent to those of ordinary skill in the art that certain changes and modifications may be made thereto without departing from the spirit and scope of the appended claims.