MEDICHECK

Clinics and Doctors office Urine Screening, Disease Identification and Blood testing.

The ability to carry out a range of tests on one system at a G,P.’s office or medical centre immediately would save millions of pounds in staff time, antibiotic usage, collection and delivery of specimens, laboratory time, repeat calls for patients and Doctors time. Seventy-five percent of all testing is negative and if these results were available to the GP in the surgery no further action would be required and this would add to the savings already noted. Medicheck accomplishes all of this.

The product is suitable for world-wide distribution. It is small enough to be used by a single doctor practice, in a clinic or a small hospital both in the developed and the third-world.
All patents on this product are internationally valid.

PRICING About £10,000 plus one PC.

DESCRIPTION OF MEDICHECK

The heart of the Medicheck system is the patented variable orifice that uses an impedance technique to measure particles. This device has been tested over some ten years in hospitals and proved to be reliable, giving excellent numeric results. It is a non-growth method so is perfectly safe to be used in a primary care situation by any of the in-house staff.

Medicheck is designed for use in medical centres or the G.P.’s office. It has a footprint of 825 sq cm (33cmx25cm) and weighs only 4Kg. It can be connected to a range of PCs with the appropriate specification. The software to operate the system is loaded via a CD and a simple connection from the PC to Medicheck completes the installation.

Disposable plastic circular plates with four compartments as sample wells are used to hold the samples. When used for urine screen the disposable plate is supplied empty as the reagent to carry out the test is provided from the container in the side of the unit. A second range of disposable plates has sealed within it reagents for the identification of specific micro-organisms, such as E coli, or components such as rheumatoid arthritis antigen. A separate disposable plate for standard blood tests takes up all four compartments within one plate.

OPERATION OF MEDICHECK

Medicheck is simple to use and is designed to be operated by a Doctor or Practice Nurse. The liquid sample is loaded into the disposable plastic plate and this is then placed into the plate holder in Medicheck. The cover on the instrument is pulled down and the test started from the computer. Medicheck controls all sample uptake and dilution.

In the case of standard urine screen and identification of bacterial contamination in urine, four different samples can be loaded into the disposable plate. A blood test will use all four wells in the plate to complete one test. All tests are fully automatic and the computer will calculate and tabulate the results.

A second plate can be loaded into Medicheck to carry out further tests directly the first tests are completed. Normal lapsed time for a single test is 1 minute. Results of the tests can be printed out or can be transmitted via the Internet to other data collecting systems for further analysis.

The test diluent and waste are contained in sealed plastic bottles held in a compartment at the side of the instrument. Waste liquid should be disposed of in a manner appropriate to clinical waste.

This is a prototype but we know from previous experience that it would pass for urine screening and blood. Other tests such as identification would need to go through a certification procedure.

SPECIFICATION OF THE MEDICHECK SYSTEM URINE SCREEN

Medicheck reports count for the following particles in urine:

• Micro organisms
• White Blood Cells
• Red Blood Cells
• Epithelial Cells

Absolute numbers are counted and are then classified for significance. The user can set the threshold values for indicating significance since not all laboratories use the same criteria for determining a ‘positive’ sample.

Results reported in a DOH evaluation of the counting technology was: sensitivity of 93% and negative predictive value of 98%

IDENTIFICATION

Medicheck will identify and report the presence of a particular organism or factor in urine. A diagnostic kit contained within the disposable plastic plate will indicate the presence of E-coli in any liquid sample. Other organisms can also be identified using the appropriate test kits.

Results from a trial for rheumatoid arthritis (R A) in serum where reported as a Sensitivity of 99.7% Specificity of 90.88%

List of some of the Agglutination tests available

• Rheumatoid Factors (R.A.).
• Hepatitis B (RPHA)
• Weil-Felix
• Cytomegalovirus (CMV)
• C-Reactive Protein (CRP)
• E.coli 0157
• E.coli K1
• E.coli SP3112
• ASL
• Syphilis (SPHA)
• HIV 1 / 2
• Rickettsia
• Candida Mannan

Up to 80 tests for different diseases / Bacteria / viruses are available on latex beads which are applicable to our technology. Any conditions which the G.P. would be interested in can be arranged to work on the system these include respiratory (flu Bronchitis) Women’s problems (Thrush Cystitis etc.). These all come under the title of Identification (Reverse agglutination). There are also 30 tests for the veterinary profession.

BLOOD TESTING

Medicheck will carry out standard blood tests for Red Blood Cells, White Blood Cells and platelets. (A standard 13 Parameter result.) The results generated are equivalent to those produced by a Coulter (TM) counter.

PARTICLE COUNTING

Medicheck will count and size particles. Increase or decrease in particle size is the basis of the diagnostic testing methods outlined above.

Possible additions to the system: HAEMOGLOBIN The inclusion of a detector, which can identify the grey scale, would give the unit the capability to read changes in density.

COMPUTER

A standard PC compatible computer is required with each Medicheck system. The detailed specification of the computer may vary. The computer should include a colour monitor, data backup disks and printer to complete the system .

SOFTWARE

The software to run Medicheck is supplied on a CD and is fully compatible with Windows 98 and above. Written within the software is the capability to organise test structures to cover the various reagents, which are supplied, packed, within the disposable specimen container.

MEDICHECK HARDWARE DIMENSIONS

• Height 32 cm
• Width 26 cm
• Depth 45 cm

All dimensions are maximum

POWER CONSUMPTION

• 25 VA max.
• Power input switchable
• 100 to 240 V AC
• 50 to 60 Hertz

WEIGHT 4 kg

CAPACITY OF RESERVOIRS

• Diluent 1 litre
• Waste 1 litre

ENVIROMENT

• Maximum ambient temperature for operation +10 to + 35⁰Celsius
• Maximum humidity for operation 10 to 90% (non-condensing)

The EVOLUTION and RATIONALE of MEDICHECK

Ten years ago we developed a large automated urine screen system called Questor, which was marketed by Difco Ltd in the U.K. some thirty units were manufactured. The manufacturing and running of the system gave us considerable experience with this type of testing and along with the standards we produce, enabled us to keep some of these units in service up to the present day. At the beginning of that project we acquired a “blue book” certification from the Medical Devices Agency and a short form copy of that document is enclosed. The essence of this system is a variable orifice device, which is a counting and sizing technology based on impedance particle counting. This is a patented device, which is part of our portfolio of patents.

The Questor system solved the urine-screening problem, satisfying the Department of Health Evaluation Unit, Public Health Laboratory to the highest level. This was the only unit (of many which were designed and marketed at that time) which successfully carried out the urine-screen function, and in fact it is still performing satisfactorily in several UK hospitals.

For some time now we have been investigating the way that testing is carried out in the UK hospital microbiology laboratories. The reluctance of these laboratories to move away from their media based procedures. There are a few progressive laboratories who will invest in new ideas but the large majority of the laboratories will not give up their media plate testing for any reason. They seem to be afraid that any method which appears to attack their present technology. This may be an unconscious reaction and irrational but we have heard it many times in lectures and seminars. It may also be that the cost of these systems appears to them to be beyond their budgets at present. This has made it very difficult to introduce any other system in large numbers into the microbiology field. A media based system is very hard to speed up and automate; in fact its very nature is one of an overnight test of more than eight hours.

As you may know the hospital laboratories earn most of their money out of the negative tests, which they consistently carry out, and this can amount to maybe 75% of all the tests they process. This is the area we am aiming at with this new product. The product we are developing at the moment is designed to cover this new market. We have called it MEDI-CHECK and it is a non-growth system based on the techniques used in our previous Questor system. To bring the technology up to date we were able to redevelop the electronics using the modern FPGA techniques and in designing the system for a lower throughput drastically reducing the build costs and size. There is a small four-well disposable, which is in a vacuum form of AB grade plastic. For the urine screen and the blood test the tray is supplied empty but for the whole range of identification the reagents will be supplied in the trays as a pre-packed product.

We contend that this new equipment will revolutionise the near-patient testing field by moving a significant proportion of the negative testing down towards the General Practitioner or medical clinic level. They would not use a growth-based system for safety reasons, but if non-media based system is offered it would appear from our investigations that they would take it on. MEDI-CHECK is a non-growth based system. The incentive is that they could gain income from it, reduce patient call-back and improve patient care simultaneously. These areas are all the initiatives the Government are calling for. The one thing they do not want is a different piece of equipment for each test. In our discussions with the doctors it was suggested that if they were able to ascertain that the test was negative then they could look elsewhere for cause or release the patient at the first visit. If the test shows positive then the patient can be given antibiotics or will be referred to the local hospital.

Some time ago we designed and built a small urine screening system to test this theory and arranged for it to be placed in a local medical centre. It won second prize it its category in a national competition and had an article published about it in a medical publication.

The information, which we were able to gather while working with the centre, was of considerable value in the design of the new equipment. The doctors wanted to know, for instance, whether a urine screen was positive or negative. If it was negative the patient was released immediately and if positive they wanted to know if the organism was e.coli or not. We carried out a study on this problem and discovered that we could indicate the type of organism by using coated beads in the system. If the beads are coated with the appropriate enzyme then the beads will clump and the system picks this up very easily. We have documented evidence of the procedure that we call reverse agglutination. One can of course coat many different enzymes on to beads and this lead us towards a very neat identification solution. The system can be organised for both organisms and virus, in the same unit. The sensitivity is greatly superior to the visual tests used for agglutination at present, i.e. as used in pregnancy testing. It uses about one tenth of the reagents used in visual tests. The instrument can count individual beads and will quickly locate two or more if they clump together. The cycle time for the technology used in both Questor and Medi-check is approximately one minute per sample.

The next area that the doctors were concerned about was an indication of negativity on a blood test. We carried out a blood test similar to the Coulter test used in hospitals and came up with the same results. This proved to us that a blood type test could be accomplished on the same unit. We also investigated a way of testing haemoglobin which could be incorporated into the system, but we were not able to work on it at the time.

The one reservation that the doctors and nurses had was the size of the Questor unit. Space is at a premium in these places. We have since been successful in reducing the size and cost considerably as previously described. The MEDI-CHECK unit is able to carry out Urine Screen, Identification and Blood Testing, which could include haemoglobin.

There is a world-wide market for this type of product. The strategy is that it would move some of the testing from the hospital laboratory down to the medical centres who would be able to charge for it, or because of the low cost of manufacture it could be marketed on a reagent rental basis. If you require further information on the patents we have been granted over the years these are available to you on the Internet in the patent section.

Refer to http://users.aber.ac.uk/dgw/patent.htm ,
http://patents.cos.com/ , http://www.patent.gov.uk/, http://www.european-patent-office.org/

Tel: +44 7903 967 355 Email: arayltd@btinternet.com or john@jhassociates.freeserve.co.uk

Information supplied by Aray and John Holley Associates . Aray
supplies the software for Medicheck.
Copyright 2002. All copyrights and Trademarks acknowledged.
24 November 2002