STRICTLY CONFIDENTIAL Initial IP Disclosure
Initial IP Disclosure Form
This form is for the disclosure of intellectual Property (IP) to the Technology Transfer Office (TTO) by employees and students at UWC. The disclosure process is aligned with the requirement of the SA IPR Act of 2008 and the University’s IP Policy.
The TTO will review the IP disclosure and provide its decision on IP protection together with some feedback
The completed IP disclosure submission and any questions may be directed to:
or 021959-2603
NB: All input below in ‘blue’ represents examples/guidelines for your information only. Your input should be in black and the blue text should be deleted before submission.
Name of inventor(s):Job Title (eg. acad., student):
Contact details (disclosing inventor/s):
Title of invention:
Date of disclosure:
1. Brief Description of Invention:
(Concise and clear description of your invention)
e.g. A lateral flow rapid (<5 mins to result), hand-held, point of care diagnostic test kit for the detection of TB and TB resistance from a blood or sputum sample
2. Problem Statement:
State the problem (identified need/gap) that your invention is designed to solve
e.g. Lack of an affordable and effective (specificity & sensitivity) rapid (less than 2 hours) point of care rapid diagnostic for the detection of TB and TB resistance
3. Why do you believe your invention is protectable by patent:
Novelty: No Prior art, i.e. new & differs from existing inventions and has never been disclosed in any previous technology or publication
Inventiveness: is not something that a person skilled in the art would consider ‘obvious’ based on existing prior art
Usefulness: has an obvious useful application and is a process or method, machine, product or composition of matter
e.g. Initial online searches (non-exhaustive) suggest that the proposed invention (process or method, machine, product or composition of matter) differs considerably from existing inventions and has not been disclosed in any way.
Based on our knowledge of the art, we believe that there is inventiveness in the development of the proposed invention that is not obvious.
The proposed invention is useful in that it can be applied for the detection of a locally important and prevalent disease and addresses a huge need in the market for a rapid (short time to result), hand-held, point of care diagnostic for the detection of TB and TB resistance which then allows for the appropriate and effective treatment regime to be selected and timeously applied.
4. Technical details of invention & stage of development:
A medical diagnostic device for detecting the presence of a target analyte in a sample (sputum, serum or whole-blood) and is for point of care testing including home and/or laboratory use.
The device would be produced in a dipstick format which uses lateral flow, where the sample flows along a solid substrate via capillary action.
The sample is applied to the dipstick where it encounters a coloured reagent which mixes with the sample and travels through the substrate encountering lines or zones which have been pre-treated with an antibody or antigen. Depending upon the analytes present in the sample the coloured reagent can become bound at the test line or zone.
The proposed invention is a rapid lateral-flow immunochromatographic assay (LFIA) test kit for the detection of anti-TB Antigen (TBA) immunoglobulin G (IgG) in sputum, serum or whole-blood samples (50-μl) using colloidal gold nanoparticles as the detection reagent and an internal control.
Experiments using sputum, sera and whole-blood samples from 55 TB patients (anti-TBA IgG concentration range, 1.2 - 10 μg/ml) and 8 controls and TBA-supplemented whole-blood samples, demonstrated that the LFIA had a sensitivity of approximately 2 μg/ml anti-TBA IgG in serum and approximately 3.5 μg/ml anti-TBA IgG in both whole blood and sputum.
The diagnostic sensitivity and specificity of the assay were 100% using ELISA-measured anti-TBA IgG as the standard.
5. Type of IP Protection Envisaged:
e.g. Patent, Trade mark, Design, Copyright
Patent for:
· The process of developing the device
· The final product and its application in the rapid detection of TB & TB resistance
6. Any Other Relevant Information:
Please add any other information you believe is relevant at this time
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