Artificial intelligence based method and apparatus for automated preparation, analysis, and screening for cancer suspicion

A method of screening for cancer risk suspicion in a subject or patient undergoing urine analysis or urinalysis referred to as UA, the method comprising the steps of:

• a) employing an apparatus comprising a mechanical arm with a pipette to automatically suction a fixed volume of unspun urine sample from a collection container, and pour it into a centrifuge tube and insert the centrifuge tube with the urine sample into one of the receptacles of a centrifuge rotating head, said step optionally is performed manually;
• b) activating by a first button labelled start that is located on the surface of the apparatus to activate the mechanical arm when pressed;
• c) activating by a second button labelled a print-label that is located on the surface of the apparatus to automatically print a label with each subject identification on each centrifuge tube with the urine sample or optionally manually write on the tube, wherein the printing is done before the tube is inserted in a centrifuge rotating head and while the tubes are held by the mechanical arm, wherein the information to be printed is typed in by an attached keyboard of a first computer and printed on each centrifuge tube with the urine sample when pressing the print-label button or optionally manually written, and optionally, a printed or hand-written label is attached manually to the centrifuge tube with the urine sample;
• d) transferring the centrifuge tube with the urine sample into a centrifuge automatically, the centrifuge comprising:
• (i) a rotating head with multiple receptacles to house 12-48 centrifuge tubes, wherein each receptacle accommodates tubes of different sizes, and (ii) electro-mechanical components to allow different speeds, rotation per minute (rpm) and duration of centrifugation, wherein the centrifuge is used to separate blood and urine;
• e) centrifuging the centrifuge tube with the urine sample automatically, wherein the centrifuge automatically closes the lid, starts and stops at pre-set rpms for a fixed duration of centrifugation, and then automatically opens the lid after centrifugation is completed, wherein step e is started by pressing a third button labelled start-centrifuge located on the surface of the apparatus, and optionally, all the steps c to e are automatically run without having to press the print-label and start-centrifuge buttons;
• f) taking out the centrifuge tube with the urine sample after centrifugation in step e is completed automatically by the mechanical arm of step a or by a different mechanical arm, tilting the tube to pour out the supernatant and tilting the tube back to upright position to keep the urine sediment inside the centrifuge tube, wherein step f starts automatically after the centrifuge stops and the lid opens in step e;
• g) injecting into the centrifuge tube, a small and fixed volume of saline or other liquid automatically, by a pipette attached to the mechanical arm of step a or a different mechanical arm to re-dissolve the sediment left at the bottom of the centrifuge tube in step f to obtain a re-dissolved sediment in the centrifuge tube;
• h) suctioning a fixed volume of the re-dissolved sediment in the centrifuge tube and depositing it on a glass slide automatically;
• i) printing by a printing component on the glass slide of step h automatically, a label with the subject identification, wherein this information is printed by pressing a fourth button labelled print-slide-label located on the surface of the apparatus or optionally by a sent key on the keyboard of the first computer, and optionally, this step is done automatically after the step h without having to type and press the print-slide-label button;
• j) moving the glass slide labelled in step i automatically by the mechanical arm of step a or by a different mechanical arm or by a conveyor belt to a site for staining the sediment deposited on the glass slide;
• k) staining the glass slide with the Papanicolaou method at the site for staining automatically either by dipping the glass slide into basins with several fluids or dyes, or by a pipette suctioning these fluids or dyes from the basin and pouring them on top of the slide;
• 1) depositing a cover slip on top of the glass slide of step k with the stained sediment automatically by the mechanical arm of step a or by a different mechanical arm, wherein the cover slip covers the expanse of the stained sediment, and optionally, this step is done manually;
• m) moving the glass slide with the stained sediment covered by the cover slip from step 1 automatically by the mechanical arm of step a or by a different mechanical arm or by a conveyor belt under a microscope for visualization of all areas covered by the cover slip, wherein the mechanical arm or the conveyor belt moves the glass slide under the microscope automatically or on command to help the visualization by the microscope of all areas of all cells present and stained on the glass slide and capturing pictures of images visualized;
• n) analyzing the pictures captured from step m under the second computer with a software comprising various algorithms, the second computer comprising content of stored data including:
• a Cytopathology Index which is a library or database with thousands of images of all cells that are found in the sample;
• o) removing the glass slide with the mechanical arm of step a or by a different mechanical arm or by a conveyor belt under the microscope after the visualization in step m is completed and depositing it in a storage box for any further examination, and optionally, this step is done manually;
• p) analyzing with an adequacy algorithm “B” for assessing the proper relationship between specimen source, cytological diagnosis, urine volume, urothelial cellularity, and obscuring features, wherein the obscuring features include non-urothelial cells including vaginal contaminants, bacteria, acute inflammation, sperm, and crystal, wherein said obscuring features in higher amounts obscure the findings and characterization of urothelial cells;
• q) analyzing with an algorithm “C” for automatically taking photos of each visual field and storing them;
• r) analyzing with an algorithm “D” for automatically counting the number of each cell in all visual fields examined;
• s) analyzing with an algorithm “E” that automatically uses data processing methods to enter the findings of the present examination into form “A” and stores the data;
• t) analyzing with an algorithm “F” that automatically uses data processing methods to enter the findings of the present and previous examinations into form “B” and stores the data;
• u) analyzing with an algorithm “G” that automatically makes decisions and decides how to proceed after the slide examination is completed, wherein the decisions are selected from a group consisting of:
• (i) when no abnormal cells are seen, send a command to print a report and send it to the referring physician (P+S) reporting negative cancer risk suspicion, and (ii) when abnormal or atypical or unidentified cells are seen, to send a command to send the slides to an expert pathologist for final review (STP) and reporting the same on probability of cancer risk suspicion;
• v) employing an algorithm “H” to automatically write a report based on the report in step u, wherein the said report includes patient or subject name, date of birth, sex selected from a group consisting of male and female, previous examination history as a yes or no, referral history, detail on type of specimen, wherein the type can be selected from a group consisting of voided, instrumented, and ileal conduit urine, an adequacy statement, wherein the adequacy statement provides information selected from a group consisting of satisfactory for evaluation statement, wherein the statement provides volume, collection type, cellularity, and cytomorphological findings, and unsatisfactory for evaluation statement, wherein the statement provides information providing reasons including small volume and not enough cells, or recognizable cells, hypercellularity because of acute inflammation;
• and w) sending the report from step v for printing automatically by a printer.