Device for non-invasive diagnosis of viruses, microbes, germs, parasites and pests

FIELD OF THE INVENTION:

The invention relates to device and methods for detecting viruses, microbes, germs, parasites and pests, which infect human, animals, plants and environment.

Discovery of a rapid point of care non-invasive test that can identify patients with very low load of pathogens can save enormous health-care costs and save time.

Basically biological material continuously generates bio-electric signals. The frequency, amplitude and shape of these electrical signals are considered the "Finger Print" of each biological material.

The FAST-Series devices are biological detectors in which the specific electromagnetic signal of the targeted biological materialis recorded as a molecule signature which represent their electromagnetic Finger Print. This recorded signal is used for the detection of its identical EM match.

BACKGROUND OF THE INVENTION:

At present, viral nucleic acid detection by realtime, PCR (RT-PCR) is regarded as the gold standard for the etiological diagnosis. However, the sensitivity and reliability of RT-PCR was questioned due to the presence of negative results in some patients who were highly suspected of having the disease based on clinical presentation and exposure history, as well as positive results in some confirmed cases after recovery. In addition, the RT-PCR method has limitations on viral load analysis for evaluating disease progression and prognosis, and unable to evaluate the efficacy of antiviral drugs.

Comparing to PCR, serological testing is advantageous with faster turnaround time, high-throughput and less workload. However, the clinical value of antibodies largely depends on the understanding of host antibody responses during infection. Given that SARS-CoV-2 is a newly emerging virus, the antibody response in COVID-19 patients remains largely unknown.

Beside specific proteins using immune-assays such as enzyme linked immune- sorbent assay (ELISA), gene expression, hybridization and sequencing techniques.

Moreover, in order to complete the diagnostic process using the currently available methods, some actions are required, including:

• It must be carried on samples.

• Sample preparation, which require very specific instruments and chemicals

• These techniques needs many hours (may be days) to obtain the results.

• Needs specialized well-trained persons, where critical skills are necessary for success in performing these techniques.

Each diagnostic method has its own sensitivity and specificity

HAND-HELD MICRO -RAMAN BASED DETECTION INSTRUMENT AND METHOD OF DETECTION.

Patent No.: US 10 ,253,346 B2

The presentdisclosure relates to a method and apparatus for rapidly detecting and identifying protein -based com pounds including bacteria, virus, drugs, or tissue abnormalities, and more particularly a portable Raman spectroscopy 20 in wounds or nasal passages. Rapid assessment and typing based spectroscope which is adaptable for examining would enable tracking the spread of such pathogens and mucosal surfaces (nares, oral, ear), interrogating a wound could significantly decrease the number of hospital-acquired site and/or inspection of a potentially contaminated object or surface for protein -based compounds including MRS A or other pathogens. The device can be adapted to tissue specimens, stool, urine, serum or secretions. This method is an active method, with safe laser beam, and the prop measure is from a very short distance.

But in the current application is passive method, detecting viruses, microbes, germs, parasites and pests signal and convert it to a energy to indicate the presence of the cause of it, the distance from the patient 3-4 meter.

REAL-TIME DIAGNOSTIC SYSTEM EMPLOYING A NON-INVASIVE METHOD TO ANALYZE THE ELECTRO-MAGNETIC FIELD RADIATED FROM A SUBJECT AND THE VARIATION THEREOF.

PCT/WO 2007/100220 A1

The present invention relates to a real-time disease diagnostic system by analyzing of anelectro magnetic field radiated from a subject and variation thereof, and more particularly to a real-time disease diagnostic system employing a non- invasive method capable of analyzing a micro electro-magnetic field and variation thereof radiated from cells, tissues and organ so a subject (i.e., a living organism), so this invention is deal the cells, tissues and organ sit self by analyzing a micro electro magnetic field and variation thereof radiated, by this the system can diagnose if target has a disease or not, by comparing the measured signal by stander healthy signal, if there change there is something wrong, the prop measure from very short distance, millimeter or touching the patient body. But in our invention deal with the disease itself, detecting viruses, microbes, germs, parasites and pests signal and convert it to a energy to indicate the presence of the cause of it, the distance from the patient 3-4 meter.

Early diagnosis virus infection prevents long-term complications and save healthcare Discovery of a rapid point of care non-invasive test that can identify patients with low viral load can save enormous health-care costs and save time.

This innovative technology for detection has the following advantages:

• Fast and have direct detection properties

• No samples need

• OF higher sensitivity as compared with traditional detection technique.

• A special device is used to detect each micro-organism.

• Applicable in many fields.

• No consumable material is needed for detection.

• Possibility to detect area and tools contamination in addition to Humans, Animals and Plants.

• Detection of very low viremia / bacteremia.

Previous studies:

-Determining the device sensitivity:

The device sensitivity conducted by made a series of dilution to determine the detection limit of the device.

-Determining the device specificity:

The device specificity conducted by mixing the calibrated material with other different materials, to determine the ability of detecting and defining the calibrated although it was mixed with other material.

- FAST series(Field Advanced Screening Tool)

PCT/EG2010/000044 The difference between the old device and the present device:

- The indicator unit is outside the device which it was non ethically for the patient in the new invention the indicator is inside the device

- There is a battery in the new device to reduce the human effect throw detection operations.

- The sensing unit, the indication unit, and power unit component is completely different.

- The shape and interface of each is different.

- A national multicenter validation of screening device (FAST) was performed on Hepatitis C. The study included 2903 cases from seven centers with one protocol under supervision of the national committee for viral hepatitis which represents the ministry of health.. HCV RNA was detected for all cases using RT-PCR. C-FAST device was applied for all cases to detect the infected patients with HCV. Sensitivity, specificity, and predictive values were determined for comparison between the two methods. Overall accuracy was 97.8%, sensitivity 100%, specificity 97.3%, positive predictive value of 89.3% and negative predictive value of 100%. Moreover, reports of results of application of C Fast device in many countries are available Results of C Fast deice were presented in many international conferences

-The Available FAST-Series Devices for humans

• C-FAST : For diagnosing HCV

A Novel Method for Non-Invasive Diagnosis of Hepatitis C Virus Using Electromagnetic Signal Detection: A Miilticenter International Study World Academy of Science, Engineering and Technology International Journal of Medical and Health Sciences Vol: 7, No: 12, 2013

CONCLUSION AND FUTURE PROSPECTS

We conclude that Electromagnetic Signal Detection (EMSD) of specific HCV RNA nucleotides using the C-FAST device is an accurate, non- invasive method for FICV diagnosis and it can be used for as case - finding or opportunistic screening. The same technology could potentially be used for diagnosis of other diseases; this may open new horizon in the applications of EMSD in biology and medicine.

• I-FAST : For diagnosing HIV

• Covid- 19 F ACT : F or diagnosing covid- 19 virus

The Available FAST-Series Devices for animals

• TB-FAST: For diagnosing Bovine tuberculosis The Available FAST-Series Devices for plants

• RW-FAST: For diagnosing Red Weevil (Rhynchophorusferrugineus)

• Rs-FAST :For diagnosing Potato brown rot (Ralstoniasolanacearum)

• RN-FAST: For diagnosing Root-knot Nematodes (M. incognita)

"Description of invention"

This invention is related to new non-invasive device diagnosis viruses, microbes, germs, parasites, pests and Infection control (on the surfaces).

Basically it affects any biological material by an electromagnetic field, that carries the same internal frequency "Finger Print" of the biological material, and consequently the resonance state occurs according to it, After maintaining the resonance state it affect its biological functions, so the genetic "Finger Print" of the target (viruses, bacteria, fungi ...) can be calculated by exposing them to an electromagnetic waves of different frequencies and measuring their activities to know if the resonance state occurred or not. For example: for viruses the activities are measured by cells line test that shows the activities of the virus once it showed that the inhibition of the virus occurred it means that the electromagnetic signal applied is near to the resonance signal, then to be more specific in order to obtain the exact electromagnetic signal which represents the finger print so after applying different electromagnetic signals near to the one that showed inhabitation effect on the vims and so on until the vims activity showed complete inhibition. That means that the finger print of the target has been obtained and this signal includes the (frequency, amplitude and shape) of the "Finger Print", then they are tested using the device and measuring the specificity and sensitivity of the target itself to ensure that the correct genetic fingerprint is obtained.

After obtaining the special specifications (frequency, amplitude and shape) for, it will produce attraction force that generates energy in the device as a result.

Basically a biological systems continuously generate bio-electric signals during metabolic activities. The frequency, amplitude and shape of these depend on the type of the” Finger Print" of the biological material, an integrated circuit which emit The same frequency, amplitude and shape, is placed and employed inside the electrical circuit (main card), so that if the target around the device has the same characteristics, metabolic function, organ and biological system, these electrical signals are considered the” Finger Print “of each biological material.

Senses the presence of the electromagnetic signal of the biological material "Finger Print", By means of a card that contains the same fingerprint signal, In case of compatibility between them, That produces a attraction force that generates energy in the device as a result, this energy is kinetic energy makes the free part of the unit within a special medium moves, which moves at the same amount of kinetic energy. Then a card transfers the amount of volt through the encoder (fig 9) that senses the motion of the free part to the Galvanometer inside the Indication Mechanism, which in turn shows this energy in the form of a moving indicator that indicates to the user that there is a positive situation as a result of the movement of the indicator.

In the absence of a similar fingerprint in the field of the device, there is no energy inside the device and therefore the card cannot move the moving part and the indicator remains constant indicating the absence of the fingerprint that the device was calibrated in the vicinity of the device.

The FAST-Series devices are biological detectors in which the resonant electromagnetic signal of the targeted micro- organism is recorded as a molecule signature which represent their nucleic acid electromagnetic Finger Print. This recorded signal is used for the detection of its identical EM match. BRIEF DESCRIPTION OF THE DRAWINGS

Figure number (1): the component of the device:

- 1- The inter face of the devise.

- 2- Body of the device.

- 3- sensing unit

- It is the unit responsible for sensing the presence of the fingerprint aroundthe device, it is consists of the following:

-Free movement unit consists of (bearing ball) which can moves without any friction within a special medium control the pall moving in a certain curved designed smooth path.

-The main control card: is the microcontroller unit, contain the electric component as shone in the fig. 8 to calculates the inputs and converts them to volts like measure the energy level of the battery and translates it as output to the rest of the device, it contain also an integrated circuit emit The frequency, amplitude and shape "Finger Print" No- (3).

- 4- indication unit

- It is responsible for expressing the movement that transfers to it from the transfer card, to show the user whether or not the fingerprint exists.

- It consists of:

- The transfer card: contain magnate IC read the movement of the moving part and transfer it to the Galvanometer.

-Galvanometer that receives movement from the transfer card and make the indicator moves, its voltage from IV TO 5 V.

-The indicator which expression that there is movement or not 5- power unit:

The Power Unit It consists of:

- The main card, which is responsible for the delivery and the regulation of power from the battery to the rest of the device, as well as clarifying the battery status.

- The battery:

Lithium battery: 4000 m A Electric charger characteristics:

Input: (100: 240 V) (50:60 Hz) (0.5 A MAX)

Output: Dc (12.6 V) - (1000 mA)

- Figure number (2) shows the inter face of the devise:

1 -The indicator:

Its movement indicates the presence of the fingerprint or not, in the event that it is moving with the target, that indicates the presence of the fingerprint, and in the event that it does not move with the target indicates the presence of the fingerprint in the target.

2- Power indicator:

Indicates that the power has arrived properly for all components of the device

3- On

It is pressed to start work, and after pressing it the power indicator should light up, in this case, the remaining work steps will be continued, but in the event the power indicator is not lit, the device must be recharged before starting work

4- Off

It is pressed when the device is finished working and making sure that the indicator returns to its original position before turning on, and all lights are off.

5- Stop

It is pressed when the detection process stops and then it is pressed again when it is started again in order to conserve the device's battery power.

6- Run

It is pressed when the detection starts, after making sure the power indicator lights up.

7- Battery Status (Bl- B2):

It indicates the energy state of the battery, in case of switching off Bl, this indicates a decrease in the energy level below 50%, in case of switching off B2, this indicates a decrease in the energy level below 25%, In this case the device must be turned off, If the device continues to operate, the device turns itself off automatically.

- Figure number (3) shows the dimensions of the device:

- 1- The Length 290 mm

- 2- The Width 126mm

- 3- The device handle width 68mm

- 4- The Height 74mm

- 5- The Handle height 50 mm

- The weight of the device 713 gm

- Figure number (4) shows- The sensing Unit, indication unit connection:

- 1- indication unit

- 2-Sensing unit

- 3- The Galvanometer

- Figure number (5) shows : The casing indication unit dimensions:

Figure number (6) shows :

Figure number (7) shows : The Galvanometer dimensions:

Figure number (8) shows ; The main cart circuit andthe lighting indication cart circuit:

Figure number (9) shows ; The transferee cart circuit:

How to use the device :

The detection device is holding by the user, the patient is away bay 3-4 meter, it’s a qualitative device which it takes about 3 mint to determine the existence of the microorganism or not. a. The detection device is qualitative biological instrument to detect the presence of a specific biological material, the detection process takes about three mints to determine the existence or absence of the targeted microorganism. b. To start detection process, hold the device and switch on the power by pressing "ON" button to put the device in standby mode, "Power" indicator, battery status indicators "Bl" and "B2" lights up.

C. Stand away from the target by 2-4 meters, then press "Run" button and point the device toward the target. d. The sensing unit senses the matching between the electromagnetic signal of the biological material fingerprint inside the target that causes the disease, and the previously calibrated biological material fingerprint in the device. e. During the detection process, In case that the electromagnetic signal of the biological material finger print that causes the disease is identical with the biological material fingerprint on which the device was previously calibrated, a quite amount of energy will be generated inside the device, which feeds the Indication Mechanism unit and the device indicates the presence of this targeted biological material, which means positive result. f. In case of non-identically, there is no energy generated inside the device, and the device does not indicate the presence of this targeted biological material, which means negative result. g. Press "Stop" button to put the device in standby mode, repeat the previous process to detect all other targets, and then press "Off' button to shut off the device.

Applications of use this technology

- Infection control

This technology can be used in detecting pollution of the surrounding environment, surfaces or instruments used with humans and the incolorization of viruses and bacteria before use, thereby reducing the transmission of infection between humans.

- Screening by device for early infections can be detected for people before complications occur where it facilitates the treatment of these conditions and prevents the spread of the disease among people who are not infected from the people who do not show any symptoms.

- This method is characterized by the ease and fast of the detection process and give a result immediately after detection.

- Relatively low cost where detection does not require consumers.

- Safety when detecting patients because of no need to get sample from the person to be examined.