U.S. patent application number 10/373276 was filed with the patent office on 2004-04-29 for method and apparatus for performing diagnostic testing.
This patent application is currently assigned to Polaroid Corporation. Invention is credited to Mauchan, Donald E., Norris, Philip R., Polizzotto, Leonard.
Application Number | 20040081586 10/373276 |
Document ID | / |
Family ID | 23653389 |
Filed Date | 2004-04-29 |
United States Patent
Application |
20040081586 |
Kind Code |
A1 |
Mauchan, Donald E. ; et
al. |
April 29, 2004 |
Method and apparatus for performing diagnostic testing
Abstract
There is provided a diagnostic assay system for conducting
luminescent reactions that generate luminescent signals and
recording the signals on an image recording medium.
Inventors: |
Mauchan, Donald E.;
(Marlboro, MA) ; Norris, Philip R.; (North
Reading, MA) ; Polizzotto, Leonard; (Stow,
MA) |
Correspondence
Address: |
POLAROID CORPORATION
PATENT DEPARTMENT
1265 MAIN STREET
WALTHAM
MA
02451
US
|
Assignee: |
Polaroid Corporation
|
Family ID: |
23653389 |
Appl. No.: |
10/373276 |
Filed: |
February 24, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10373276 |
Feb 24, 2003 |
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09417297 |
Oct 13, 1999 |
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6555060 |
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60104150 |
Oct 14, 1998 |
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Current U.S.
Class: |
422/82.08 ;
436/172 |
Current CPC
Class: |
G01N 21/645 20130101;
G01N 21/76 20130101; G01N 2201/0221 20130101; G01N 21/8483
20130101; G01N 21/8507 20130101 |
Class at
Publication: |
422/082.08 ;
436/172 |
International
Class: |
G01N 021/64 |
Claims
What is claimed is:
1. A portable diagnostic assay system for conducting a luminescent
test and recording luminescent signals generated thereby on an
image recording material, the system comprising: a processor
including a portable, hand-held and light-tight housing having
first and second openings, and a shutter mechanism within the
housing and being located at an exposure station so as to be
operable for operation between unblocking and blocking conditions
relative to at least one exposing aperture in response to
corresponding insertion and removal of a removable sample carrier
from the housing; and, a fluid processing assembly in the housing
for processing self-developing film units; at least one luminescent
testing assembly capable of generating a luminescent activity; a
sample carrier that carries the testing assembly and is insertable
in and withdrawable from the second opening for operating; one of
the luminescent testing assembly and sample carrier being
constructed to activate the shutter mechanism to the unblocking
condition when inserted into the second opening, and allow the
shutter mechanism to return to the blocking condition when removed
from the second opening; whereby when the shutter mechanism is in
the unblocking condition a luminescent reaction conducted on the
film assemblage can expose the film through the exposure aperture;
and, an image recording assemblage is housed in the processor at
the exposure station.
2. The system of claim 1 wherein image recording assemblage is a
self-developing integral film unit having an image recording area
and a pod of processing fluid, the film unit is housed in the
processor at the exposure station; and is capable of being
processed as it advances from the housing.
3. The system of claim 2 wherein the film assemblage has a leading
portion thereof extending from the first opening in the housing;
and the assemblage is pullable from the first opening so that the
exposed image area thereof can be have its latent image processed
by the fluid processing means as the assemblage is pulled from the
housing.
4. A hand-held, portable diagnostic assay system for conducting and
recording luminescent reactions that generate luminescent read-out
signals and are recordable an image recording medium, the system
includes a housing assembly defining an enclosure carrying at least
the image recording medium, and an exposure opening that optically
communicates the recording medium with the luminescent signal; a
carrier assembly has one condition for receiving a luminescent
testing assembly that is capable of generating the luminescent
read-out signal recordable on the recording medium through the
exposure opening, and a second condition in which the carrier
assembly is insertable through an opening in the housing into the
enclosure to form a light-tight enclosure for allowing the
recording medium to be exposed with the luminescent signal.
5. The system of claim 4 further including a shuttering mechanism
in operative relationship to the enclosure and which moves into an
exposing condition relative to the exposure opening when the
carrier is inserted into the enclosure and returns to a light
blocking condition relative to the exposure opening when the
carrier is removed from the enclosure.
6. The system of claim 5 wherein the image recording medium is a
self-developing film unit which is processed as the film unit is
advanced from the housing after passing therethrough.
7. A hand-held, portable diagnostic assay system for conducting and
recording luminescent reactions that generate luminescent read-out
signals and are recordable an image recording medium, the system
includes a housing assembly defining a light-tight enclosure
carrying at least the image recording medium, and an exposure
opening that optically communicates the recording medium with the
luminescent signal; a carrier assembly has one condition for
receiving a luminescent testing assembly that is capable of
generating the luminescent read-out signal recordable on the
recording medium through the exposure opening, and a second
condition in which the carrier assembly forms a light-tight
enclosure, whereby the luminescent testing assembly is in optical
communication with the recording medium through the exposure
opening for allowing the latter to be exposed to a luminescent
signal.
8. The system of claim 7, wherein the test assembly includes a
container having a transparent bottom portion that is insertable
into an opening in the carrier assembly, the carrier assembly
opening being out of optical communication with the exposure
opening when the carrier assembly is in the first condition and in
optical communication when the carrier assembly is in the second
condition, whereby a luminescent signal is recordable on the
recording medium when the carrier assembly is in its second
condition.
9. The system of claim 8 wherein the test container comprises a
reservoir that stores a luminescent testing fluid that is sealed by
a sealing membrane; and, a sample testing device which contains a
sample to be tested and is inserted into the container such that it
penetrates the sealing membrane such that the sample testing device
cooperates with the sample fluid.
10. The system of claim 9 wherein the luminescent testing assembly
includes a sampling device which can sample a surface to be tested
and then be inserted, in a light-tight manner, within the test
container such that a portion thereof penetrates the membrane and
is immersed in the fluid.
11. The system of claim 8 wherein the carrier assembly is rotatable
in the housing from the first condition wherein the transparent
reservoir portion is out of registry with the exposure opening and
the exposure opening is blocked from light to the second condition
wherein the transparent reservoir portion is in optical
communication to the exposure opening for exposing the film.
12. The system of claim 7 further including means for effecting and
recording a luminescent read-out signal of a control test in
addition to the luminescent read-out signal of a test sample.
13. The system of claim 7 wherein the carrier assembly carries the
luminescent sample test assembly and a luminescent control test
assembly, the carrier assembly also includes fluid transfer means
for allowing transfer of the control and test fluids; respectively,
from separate ports in the housing to the respective test
assemblies.
14. The system of claim 13 wherein the fluid transfer means
comprises capillary grooves in a light-tight arrangement.
15. The system of claim 11 wherein the carrier assembly includes a
cover member movable from a position for allowing the fluid
container to be inserted into the carrier assembly opening to a
light-tight position over the fluid container, wherein the cover
member causes an actuating member of the fluid container to
penetrate the sealing membrane so that fluid of one reservoir in
the fluid container can mix with the luminescent testing fluid for
generating the read-out signal.
16. The system of claim 7, further including means for quantifying
the luminescent read-out signal generated and recorded on the
film.
17. The system of claim 16 wherein the quantifying means includes
an optical filter element comprising a series of alternating
transparent and opaque zones that act to delineate different sized
read-out signals; whereby different sized developed latent images
correlate to corresponding different test results, thereby
providing a visual measurement of the test results.
18. The system of claim 17 wherein the quantifying means includes a
series of existing symbols of different sizes on the film wherein
each size corresponds to a different strength of a read-out signal,
so that the read-out signal captured by the test can be compared to
the different symbols.
19. The system of claim 11 wherein the fluid container includes
first and second separable reservoirs, the first contains the
luminescent testing fluid and is sealed by the sealing membrane,
the first reservoir includes transparent walls for allowing a
luminescent read-out signal to expose the image recording medium;
the second reservoir includes an actuating element at one end
thereof, the second reservoir being separable from the first
reservoir and contains a fluid into which a reagent of interest can
be inserted, such that the actuating element when actuated
penetrates the membrane to allow the fluid and analyte of interest
to mix with the testing fluid for commencing a luminescent
reaction.
20. A method of detecting and recording the presence of a reagent
of interest in a test sample, comprising the steps of: providing a
self-contained processor having a luminescent testing material
capable of generating a read-out signal in response to contact with
a reagent of interest; providing an image recording assembly to be
exposed to the read-out signal; introducing the test sample into
the processor so that a reagent of interest can cooperate with the
testing material; exposing the image recording assembly in a
light-tight enclosure in the processor to a luminescent reaction of
the reagent of interest and the testing material; and, initiating
development of the exposed portion by passing it through pressure
applying processing means in the processor and withdrawing the
exposed portion from the enclosure by pulling on the film
leader.
21. A method of detecting and recording the presence of a reagent
in a sample of test fluid; said method comprising the steps of:
providing a self-contained processor having a luminescent testing
assembly in a light-tight enclosure capable of generating a
luminescent read-out signal in response to presence of a reagent in
a test fluid sample; introducing a test sample fluid through a port
in the processor; transporting the fluid sample to a luminescent
testing assembly within the processor for generating a luminescent
signal if the reagent is present; exposing a portion of a
self-developing film unit retained in a light-tight portion of the
processor to the luminescent signal; and, initiating development of
the exposed portion by pulling on an extension portion of the film
unit protruding from the processor, whereby the exposed portion
passes from the light-tight portion to pressure applying processing
means in the processor.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present invention relates to copending U.S.
non-provisional patent application, (Atty. Dkt. No. 8340-AFP)
entitled "Diagnostic Assay System and Method; filed on Oct. 6,
1999.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to diagnostic assay
systems and methods capable for multiple samples in a simple and
reliable manner.
[0003] A wide variety of systems and approach 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.
[0004] 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
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] Methods are contemplated for conducting and recording
read-out signals that can expose the image recording material.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] It is another object of the present invention to detect the
luminescent signals electronically and print relevant information
on the film.
[0017] 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.
[0018] 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
[0019] 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;
[0020] FIG. 1A is an enlarged and fragmented schematic view of a
film assemblage that can be used in connection with the
invention;
[0021] FIG. 2 is a schematic exploded perspective view illustrating
components of the assay system;
[0022] FIG. 3 is a bottom plan view of a sample carrier component
of the assay system;
[0023] FIG. 4 is a bottom plan view of alternate embodiment of a
sample carrier;
[0024] FIG. 5 is a view of an alternate embodiment of a diagnostic
assay system of the present invention;
[0025] FIG. 6 is an enlarged schematic view of the interaction
between the a sample carrier and a shutter mechanism;
[0026] FIG. 7 is a plan view of an optical filtering arrangement
for use in the diagnostic assay systems;
[0027] FIG. 8 is a plan view of another embodiment of an filtering
arrangement;
[0028] FIG. 9 is a schematic view of yet another preferred
embodiment of a processor of the present invention; and,
[0029] FIG. 10 is a cross-sectional view of a test container usable
in the processor of FIG. 9.
DETAILED DESCRIPTION
[0030] 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 application 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 20a, an image recording
area 20b, a pod 20c of processing fluid located at a leading end
portion, and a fluid trap 20d at a trailing end. The photosensitive
image recording area 20b 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 20c is positioned adjacent
the processing means, as will be described and a tab or leader
portion 20a 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.
[0031] 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.
[0032] 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 58a, 58b 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.
[0033] 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 microorganisms. 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.
[0034] 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 67a and a lower end
portion 90 is fit within a lower portion 67b of the housing above
the sealing membrane. A projecting rim 92 extends radially from the
collar and is adapted to rest on the shoulder 67a.
[0035] 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 58b being engaged by the collar rim 92 and the shoulder
58a engaging a surface 67c 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.
[0036] 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
aperature 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's (not shown) that would be attached to the housing and
otherwise actuatable to record desired information.
[0037] 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.
[0038] 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.
[0039] 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 20a 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.
[0040] 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.
[0041] 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'.
[0042] 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 20a 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 123 returns to
a position which allows it to be engaged by the tray.
[0043] 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 is 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.
[0044] 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.
[0045] 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
chemilumenescent 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.
[0046] 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 includes 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.
[0047] 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's 206. Operation of the LED's
206 exposes a film units of a film assemblage 16. The LED'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'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.
[0048] 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.
[0049] 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.
[0050] 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'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.
[0051] 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.
* * * * *