Container and method for supporting home testing and diagnosis of infectious diseases
Inventors
Darrigrand, William A. • Formica, P. Michael • Zunda, Charles • Judson, Jared Alden • Klein, Devorah Emily • Pangaro, Gian A. • Robinson, Jason
Assignees
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Publication Number
US-7998757-B2
Publication Date
2011-08-16
Expiration Date
Abstract
A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.
Core Innovation
The invention provides a home infectious-disease testing kit/container for performing a test and determining a test result. The container includes an upper portion and a lower portion connected together, where the upper portion has at least one receiving space and is configured to receive and hold a combination of a first test device and a second test device in a testing position during a test. The lower portion defines an interior space and includes a moveable tray disposed in the interior space.
An instructional insert is disposed between the upper portion and the lower portion, and devices and components are accessed by sequentially positioning the instructional insert to gain sequential access to the first test device in the movable tray. The instructional insert contains written instructions, and access to the next devices and components is guided by sequential removal and access to correspond with the instructions. The method includes accessing at least one instruction from the instructional insert, accessing the movable tray based on the instruction, and accessing the second test device disposed in the movable tray in correspondence to the instruction.
The kit/container supports performing a testing act directed by the instructional insert using at least one of the first test device or the second test device in correspondence to the instruction. The method further includes disposing the second test device in the first test device to form the combination of the first test device and the second test device, positioning the combination in the receiving space in the testing position, and determining a test result based upon the testing act. The description additionally covers embodiments that discourage premature result reading, and includes optional tamper detection and contamination prevention and optional pre-test and post-test counseling via phone and website with a call center workflow including inquiry and response modules and referral services.
Claims Coverage
The independent claim describes a method centered on instruction-directed sequential access and use of a first and a second test device within a testing kit/container, where an instructional insert controls sequential access and corresponding testing acts. Across the family, dependent claims refine the instruction format, extend multi-instruction sequencing and corresponding acts, narrow the testing purpose to a predetermined infectious disease, and require interpreting the test result in accordance with the insert. The independent inventive features are captured below for the single independent claim identified.
Sequential access directed by an instructional insert
A method of sequentially accessing test devices located within a testing kit as sequentially indicated to perform a test and determine a test result, including opening a container with an instructional insert and sequentially positioning the instructional insert to gain sequential access to a first test device in a movable tray.
Movable tray storing first and second test devices for combination
A container structure in which a moveable tray disposed in an interior space includes a first test device disposed in the movable tray, with a second test device configured to be disposed in the first test device to form the combination, and the combination configured to be positioned in a receiving space in a testing position during a test.
Correspondence between accessed instructions and sequential test acts
Accessing at least one instruction from the instructional insert; accessing the movable tray based on the at least one instruction; accessing the second test device disposed in the movable tray in correspondence to the at least one instruction; performing a testing act directed by the at least one instruction utilizing at least one of the first test device or the second test device in correspondence to the at least one instruction.
Test result determination based on the testing act
Disposing the second test device in the first test device to form the combination, positioning the combination in the receiving space in the testing position, and determining a test result based upon the testing act.
Instruction format including textual and graphical instructions
Accessing at least one instruction from the instructional insert such that the accessing involves retrieving both textual instructions and graphical instructions.
Multi-instruction sequential access with corresponding acts
Sequentially positioning the instructional insert to gain sequential access to the first test device for a plurality of instructions, accessing the second test device in correspondence to the plurality of instructions, and sequentially performing acts directed by the plurality of instructions.
Testing a predetermined infectious disease
The combined first test device and second test device forms a testing device used to test and diagnose a predetermined infectious disease.
Interpreting a test result according to the insert
Interpreting the test result based upon instructions provided in the instructional insert.
The claims coverage is concentrated on instruction-directed sequential access within a home testing kit/container, using a movable tray and a two-part device combination positioned in a receiving space for a testing act, followed by determining a test result. Dependent claim refinements specify instruction format, multi-step sequencing with corresponding sequential acts, a predetermined infectious disease testing and diagnosis purpose, and interpreting the test result according to insert instructions.
Stated Advantages
Guiding sequential access to test devices and components so the user accesses and performs testing acts in correspondence with instructions.
Discouraging premature result reading through embodiments that cover processing steps.
Providing optional tamper detection and contamination prevention.
Providing optional pre-test and post-test counseling via phone and website with call-center workflow and referral services.
Documented Applications
Home infectious-disease testing using a kit/container with sequential instruction-guided access to first and second test devices to perform a test and determine a test result, with examples including HIV and hepatitis C and reference to an OraQuick Rapid HIV-1/2 Antibody Test context.
Pre-test and post-test counseling via phone and website, including call center inquiry and response modules and referral workflows.
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