Radiant energy – Photocells; circuits and apparatus – With circuit for evaluating a web – strand – strip – or sheet
Reexamination Certificate
1999-10-06
2001-12-18
Le, Que T. (Department: 2878)
Radiant energy
Photocells; circuits and apparatus
With circuit for evaluating a web, strand, strip, or sheet
C250S559020, C250S483100, C422S052000
Reexamination Certificate
active
06331715
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to diagnostic assay systems and methods and, in particular, diagnostic assay systems and methods for recording luminescent activities on image recording material in a reliable and economical manner.
Recording the occurrence of luminescent reactions, such as of the chemiluminescent type for qualitative and quantitative results on image recording devices is well known in the diagnostic assay art. A class of analytical instruments referred to as luminometers are typically used to conduct and record luminescent reactions of, for instance, a biological fluid containing 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 fitted with imaging systems based on CCD cameras; and photographic camera luminometers. 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; and 5,035,866. Heretofore known prior art in this field tends to be limited in a number of ways, such as being expensive due to among other factors expensive electronics, requiring relatively significant training in order to operate and being relatively cumbersome in construction and/or use.
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, provision is made for a method of detecting and recording the presence of a luminescent activity. The method includes the steps of: providing a self-contained processor having a luminescent testing material capable of generating a read-out luminescent signal recordable on image recording material 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 unit 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 it through pressure applying processing means in the processor and withdrawing the exposed portion from the enclosure by pulling on the film leader.
In another illustrated embodiment, there is provided a method of detecting and recording the presence of a reagent in a sample of test fluid. Included is the steps of providing a self-contained processor having a luminescent testing assembly in a light-tight enclosure capable of generating a luminescent 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.
Yet another embodiment includes a method of detecting and recording the presence of a reagent in a test sample; wherein the method comprises the steps of providing a self-contained processor having a luminescent testing material in a light-tight enclosure capable of generating a luminescent 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.
In another embodiment, provision is made for transporting the sample fluid by inducing capillary flow thereof. In such embodiment, the capillary flow is conducted in a light-tight manner.
In another embodiment, provision is made for transporting the sample fluid 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.
Another illustrated embodiment includes a diagnostic assay system for detecting and recording the presence of a luminescent signal generated in a manner noted above. The 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. Included is means for introducing the test sample into the processor so as to cooperate with the test material; as well as means for exposing the exposable portion to a luminescent signal. The system includes 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.
In another illustrated preferred embodiment, provision is made for a diagnostic processor apparatus. The apparatus includes a housing assembly having a film assemblage therein, preferably of the self-developing type. A reservoir containing fluid is retained within the housing assembly that is a solution carrying a reagent capable of generating a luminescent activity when in the presence of a reagent of interest that is found in a test sample. Provision is made for means for transferring a light signal to the film assemblage. Means are provided for sealing the fluid in the reservoir and are operable for allowing introduction of a test sample member carrying a test sample to be tested into the reservoir.
In an illustrated embodiment, the sealing means includes a penetrable membrane. Also, provision is made for a test sample member that penetrates the sealing means and enters the reservoir with a reagent of interest. Light-shielding means on the test sample member prevents ambient light from entering the reservoir and, thereby striking the film after the test sample penetrates the sealing membrane.
It is an object of the present invention to provide an improved method and system for conducting and recording luminescent reactions, wherein the results are immediately and reliably made known to an operator and permanently recorded.
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 for providing a platform wherein the film can be loaded during assembling.
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 that is disposable after single
Mauchan Donald E.
Norris Philip R.
Coryea Paul M.
Le Que T.
Polaroid Corporation
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