Apparatus for performing diagnostic testing

• US 6,555,060 B1
• Filed: 10/13/1999
• Issued: 04/29/2003
• Est. Priority Date: 10/14/1998
• Status: Expired due to Fees

• Current Assignee: Hanger Solutions, LLC (IP Investments Group LLC)
• Original Assignee: Polaroid Corporation (PLR IP Holdings LLC)
• Inventors: Polizzotto, Leonard, Mauchan, Donald E., Norris, Philip R.
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US09/417,297
• Time in Patent Office: 1,294 Days
• Field of Search: 422/52, 422/82.05, 422/82.08, 250/361.C, 250/458.1, 250/459.1
• US Class Current: 422/52
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 21/8507 Probe photometers, i.e. with optical measuring part dipped into fluid sample
• CPC Class Codes: G01N 2201/0221 Portable; cableless; compact; hand-held

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.

Claims

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;

said 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 which are recordable on 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 is inserted through an opening in the housing into the enclosure for allowing the recording medium to be exposed with the luminescent signal, wherein said 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, and wherein said 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.

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. The system of claim 4 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.

8. The system of claim 4 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.

9. The system of claim 8 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.

10. The system of claim 8 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.

11. The system of claim 4 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.

12. The system of claim 4 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.

13. The system of claim 12 wherein the fluid transfer means comprises capillary grooves in a light-tight arrangement.

14. The system of claim 4, further including means for quantifying the luminescent read-out signal generated and recorded on the film.

15. The system of claim 14 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.

16. The system of claim 15 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.