Diagnostic assay system and method having a luminescent readout signal

• US 6,331,715 B1
• Filed: 10/06/1999
• Issued: 12/18/2001
• 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: Norris, Philip R., Mauchan, Donald E.
• Primary Examiner(s): LE, QUE TAN
• Application Number:
  US09/412,845
• Time in Patent Office: 804 Days
• Field of Search: 250/559.4, 250/559.02, 250/483.1, 250/484.2, 396/612, 422/52, 422/61, 422/102, 422/68.1, 422/87, 436/44, 436/46, 436/47, 436/172
• US Class Current: 250/559.4
• 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

Abstract

The present invention provides a method 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 in a test sample. In an alternate aspect, the present invention also provides a portable and self-contained diagnostic assay system for detecting and recording the presence of a luminescent signal generated by a reaction between a luminescent testing material and a reagent in a test sample on a self-developing film assemblage.

Claims

1. The method includes 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 in a test sample;

providing a film assemblage of the self-developing type having a portion to be exposed and a leader extending from the processor;

introducing the test sample into the processor so as that a reagent of interest can cooperate with the test material;

exposing the exposable portion of the self-developing film type retained in a light-tight enclosure in the processor to a luminescent reaction of the reagent of interest and the test material; and

, initiating development of the exposed portion by passing the exposable portion through pressure applying processing means in the processor and withdrawing the exposed portion from the enclosure by pulling on the film leader.

2. 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 the 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.

4. The method of claim 2 wherein the step of transporting the sample fluid includes utilizing capillary flow.

5. The method of claim 4 wherein the capillary flow is conducted in a light-tight manner.

6. The method of claim of 5 wherein the step of transporting the sample fluid is carried out by a molded labyrinth internal of the processor.

7. The method of claim 4 wherein the step of transporting the sample fluid is by capillary action carried out by providing an opaque, biologically inert and porous assembly which is interposed between the port and the luminescent testing material.

3. A method of detecting and recording the presence of a reagent in a test sample;

said method comprising the steps of;

providing a self-contained processor having a luminescent testing material in a light-tight enclosure capable of generating a luminescent read-out signal in response to presence of a reagent in a test sample;

introducing a probe into contact with the testing material;

said introducing step including the step of penetrating a light-tight sealing member in the processor prior by the probe;

exposing a portion of a self-developing film unit retained in a light-tight portion of the processor to the luminescent signal if the reagent is present on the probe by passing the signal through a transparent wall portion of the enclosure which can expose the film portion to the 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.

8. A portable and self-contained diagnostic assay system for detecting and recording the presence of a luminescent signal generated by a reaction between a luminescent testing material and a reagent in a test sample on a self-developing film assemblage including a strip of self-developing film having a single exposable area with a light-tight enclosure;

said system comprises;

a portable and self-contained processor housing assembly for containing a luminescent testing material capable of generating a luminescent read-out signal in response to contact with a reagent in a test sample;

means for introducing the test sample in to the processor so as to cooperate with the test material;

means for exposing the exposable area to a luminescent signal; and

, processing means in the processor housing assembly for allowing the exposed portion to pass therethrough so as to initiate development of the exposed portion in response to pulling on an extension portion and withdrawing the exposed portion from the enclosure.

9. A portable and self-contained diagnostic assay system for detecting and recording the presence of a luminescent test sample signal generated by a reaction between a luminescent testing material and a reagent in a test sample;

said system comprises;

a processor housing assembly for containing a luminescent testing material capable of generating a luminescent signal in response to contact with a reagent in a test sample;

a luminescent testing material in a housing assembly capable of generating a luminescent test sample signal in response to contact with a reagent in the test sample;

a self-developing film assemblage including a strip of self-developing film having a single exposable portion within a light-tight enclosure in the housing assembly, a leading end portion of the film strip extends from an exit in the housing assembly for allowing a user to withdraw the film from the housing assembly in response to pulling of the leading portion;

means for introducing the test sample into the processor so as to cooperate with the test material;

means for exposing the exposable portion to a test sample signal; and

, processing means in the processor housing assembly for allowing the exposed portion to pass therethrough so as to initiate development of the exposed portion in response to pulling of the leading end portion whereby the film is withdrawn from the enclosure.

10. The system of claim 9 wherein the means for introducing the sample fluid includes means for effecting capillary flow.

11. The system of claim 10 wherein the means for effecting capillary flow is conducted by a labyrinth passageway, which is, molded internally of the processor and effects a light-tight relationship.

12. The system of claim 10 wherein the means for effecting capillary flow is an opaque, biologically inert and porous assembly that is interposed between a fluid inlet port in the housing assembly and the luminescent testing material.

13. A diagnostic processor apparatus comprising:

a housing assembly having a film assemblage therein, a reservoir which can contain a fluid is retained within the housing assembly which fluid is a solution carrying a reagent capable of generating a luminescent read-out signal activity when in the presence of a reagent of interest that is found in a test sample;

means for transferring a light signal to the film assemblage; and

, means is provided for sealing the fluid in the reservoir and is operable for allowing introduction of a test sample member carrying a test sample to be tested into the reservoir.

14. The processor according to claim 13, wherein the sealing means includes a penetrable membrane.

15. The processor according to claim 14, further including a test sample member that penetrates the sealing means and enters the reservoir with a reagent of interest.

16. The processor according to claim 14, further including light-shielding means on the test sample member for preventing ambient light from entering the reservoir and, thereby striking the film after the test sample penetrates the sealing membrane.

17. The processor according to claim 14, wherein reservoir includes a transparent window in juxtaposed relationship to the film for exposing the latter.

18. The processor according to claim 13, wherein processor housing has a construction allowing it to be held and portable.