Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Reexamination Certificate
1994-06-07
2001-11-20
Stucker, Jeffrey (Department: 1648)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
C435S007100, C435S007800, C435S007900, C435S007920, C435S007930, C435S007940, C435S007950, C435S974000, C436S528000, C436S530000, C422S051000, C422S051000, C422S051000, C422S051000, C422S067000, C422S067000
Reexamination Certificate
active
06319665
ABSTRACT:
This application relates to a test kit for use in the detection of diseases, hormone levels, and other physiological conditions, and in particular to a test kit for home use in circumstances such as detection of HIV infections where counseling is considered necessary or desirable in the event of a positive result.
Increasingly, assays for the detection of disease-causing organisms and physiological conditions are becoming simplified such that testing can be performed by the individual patient without the involvement of a medical professional. Such testing by the individual is desirable because it can reduce the costs, and provide an immediate answer to an individual's health concerns without the need to schedule an appointment with a medical professional or to await the processing of a sample by a laboratory. Moreover, many individuals prefer the privacy afforded by performing tests in their own home. Nevertheless, in some circumstances, the significance of the test result may be such that it is deemed necessary or desirable to provide counseling to the individual at the time the test result is obtained. This requirement for counseling has meant that the privacy and reduced costs associated with home testing have not been available for some types of tests.
It is an object of the present invention to provide a home test kit which facilitates the delivery of any necessary counseling as a result of the outcome of the test.
It is a further object of the invention to provide a home test kit for HIV infections which facilitates the delivery of any necessary counseling as a result of the outcome of the test.
To provide methods of making kits for use in accordance with the invention, and a method of performing home testing where any necessary counseling is provided to the individual at the same time that the results are conveyed.
SUMMARY OF THE INVENTION
These and other objects of the invention are achieved using a method for self-testing in which the individual being tested first obtains a sample of physiological fluid, e.g., blood, urine, sputum or saliva, from him or herself, and introduces the sample into an assay system which produces a coded pattern indicative of the presence or absence of the disease or physiological condition. The individual then transmits the coded pattern to a remote location, for example by making a telephone call to an interpretation center, and receives from the remote location an interpretation of the coded pattern together with any counseling which may be appropriate in view of the interpretation of the coded pattern.
The assay system employed in the method of the invention is advantageously made so that the coded patterns indicative of a positive or negative result are dependent on an identifier, such as a lot number or serial number, assigned to the assay system or kit containing the assay system. Linking the coded patterns, and thus the interpretation of the test result to the particular kit being used makes it necessary to utilize the remote location for interpretation in each instance, even if tests for the same disease or physiological condition have been performed by the same individual before.
REFERENCES:
patent: 4178360 (1979-12-01), Cleeland et al.
patent: 4535057 (1985-08-01), Dreesman et al.
patent: 4818678 (1989-04-01), Oldstone et al.
patent: 4818688 (1989-04-01), Adamich et al.
patent: 4837167 (1989-06-01), Schoemaker et al.
patent: 4838275 (1989-06-01), Lee
patent: 4839288 (1989-06-01), Montagnier et al.
patent: 4855224 (1989-08-01), Berman et al.
patent: 4879219 (1989-11-01), Wands et al.
patent: 4888290 (1989-12-01), Kortright et al.
patent: 4917998 (1990-04-01), Burger et al.
patent: 4918166 (1990-04-01), Kingsman et al.
patent: 4921787 (1990-05-01), Riggin et al.
patent: 4983529 (1991-01-01), Stewart et al.
patent: 5001049 (1991-03-01), Klein et al.
patent: 5008183 (1991-04-01), Osther
patent: 5104790 (1992-04-01), Flesher et al.
patent: 5135864 (1992-08-01), Montagnier et al.
patent: 5141850 (1992-08-01), Cole et al.
patent: 5156949 (1992-10-01), Luciw et al.
patent: 5173399 (1992-12-01), Mehta et al.
patent: 5188937 (1993-02-01), Schulte et al.
patent: 5204095 (1993-04-01), Goodall et al.
patent: 5208321 (1993-05-01), Hovanessian et al.
patent: 5221610 (1993-06-01), Montagnier et al.
patent: 5252459 (1993-10-01), Tarcha et al.
patent: 5256561 (1993-10-01), Chin
patent: 5260189 (1993-11-01), Formoso et al.
patent: 5281395 (1994-01-01), Markart et al.
patent: 5413764 (1995-05-01), Haar
patent: 0392283 (1990-10-01), None
patent: 0492326 (1992-07-01), None
patent: 88/10272 (1988-12-01), None
patent: 92/21977 (1992-12-01), None
Promotional Materials for CAPILLUS HIV Test, Cambridge Biotech Corp. (undated).
Legg Kenneth D.
Zwanziger Ron
Inverness Medical Technology, Inc.
Oppedahl & Larson LLP
Stucker Jeffrey
LandOfFree
Home test kit and method with telephone verification of results does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Home test kit and method with telephone verification of results, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Home test kit and method with telephone verification of results will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2596427