Prostate cancer point of care diagnostics
AssigneesUniversity of Texas Health Science Center, William Marsh Rice University
InventorsJohn T. McDevitt, Nicolaos Christodoulides, Pierre N. Floriano, Ian Thompson
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Abstract
The invention relates to point of care diagnostic disposables, devices, methods, and systems for diagnosing or predicting prostate cancer. The present invention employs biomarker specific reagents in disposable cassettes or lab cards for use as analyzers, as well as software to evaluate and report test results. The system promises to improve point of care in vitro diagnostics.
Claims23
1) A method of point of care testing to distinguish prostate cancer from benign prostate diseases, said method comprising:
- a) collecting information during a patient visit, said information including said patient's age, race, family history, previous biopsy results, and previous digital rectal examination results;
- b) inputting said patient information into a portable device comprising microfluidics, a power source, electronics, image detection and analysis means, data input means, data display means, and a slot comprising a removable, disposable cartidge comprising reagents for measuring free-PSA, complexed-PSA or pro-PSA, and total PSA;
- c) collecting a biological sample from said patient during said visit;
- d) applying said sample to said disposable cartridge and placing said disposable cartridge in said slot;
- e) wherein said portable device performs an assay to obtain free-PSA, complexed-PSA and/or pro-PSA, and total PSA measurements in said sample,
- f) wherein said device computes the risk of prostate cancer based on said measurements and said information wherein:
- i) if total PSA≦4, then report PSA level and risk of prostate cancer;
- ii) if total PSA≧10, then report PSA level and risk of prostate cancer;
- iii) if total PSA>4 and <10, then include free-PSA levels in said risk calculation and report PSA level, percent free-PSA level, risk of prostate cancer, and risk of high grade prostate cancer;
- g) wherein said device communicates said risk to said patient in the same patient visit as said collecting step a).
10) A disposable cartridge comprising a planar support having an inlet port fluidly connected to a detection widow, said detection window having an array of agarose beads or disks separately conjugated to a first antibody for measuring total PSA, a second antibody for measuring free-PSA and a third antibody for measuring complexed-PSA or pro-PSA, said planar support further comprising at least one closed wash chamber comprising wash fluid, wherein said chamber when open is fluidly connected to said array, and wherein said detection window allows visual inspection of said array from above said disposable cartridge.
17) A disposable cartridge comprising;
- a) a planar support having an inlet port fluidly connected to a detection widow;
- b) said detection window having an array of agarose beads or disks therein, said agarose beads or disks being separately conjugated to i) a total PSA capture antibody, ii) a free-PSA capture antibody, iii) a complexed-PSA capture antibody, iv) a series of known amounts of free PSA for calibration;
- v) a series of known amounts of complexed PSA for calibration;
- vi) a negative control containing no PSA and no antibody for PSA;
- c) at least one closed wash fluid chamber and a closed antibody chamber comprising dry detection antibody labeled with a fluorescent dye for detecting any captured PSA, wherein said closed chambers when open are fluidly connected and upstream of said array and wherein said wash fluid chamber is upstream of said antibody chamber;
- and
- d) an empty chamber fluidly connected and downstream of said array for receiving waste fluids.
21) A disposable cartridge comprising a planar support having an inlet port fluidly connected to a detection widow:
- a) said detection window having an array of agarose beads or disks separately conjugated to at least two antibodies selected from the group consisting of anti-total-PSA antibody, an anti-free-PSA antibody, an anti-complexed-PSA antibody, an anti-pro-PSA antibody, an anti-carcinoembryonic antigen antibody, an anti-chromogranin A antibody, an anti-neuron-specific enolase antibody, an anti-prostatic acid phosphatase antibody, an anti-PCA3 antibody, an anti-prolactin antibody, an anti-deoxypyridinoline antibody, an anti-testosterone antibody, and an anti-Dehydroepiandrosterone antibody;
- b) said planar support further comprising at least one closed wash chamber comprising wash fluid, wherein said chamber when open is fluidly connected to said array, and
- c) wherein said detection window allows visual inspection of said array.
Dependencies are inferred from the claim text.