Description:Title of the Invention
“A Fluorescence Microscopy Device for TB Detection”

Field of the Invention
The present invention is relates to field of medical devices which detect the Mycobacterium tuberculi (TB) bacterial count through a device comprising the GUI software and a light source for illumination which detects the fluorescence images TB bacterial cell.
Background of Invention
Information from the background discussion that follows could be helpful in comprehending the current invention. It does not imply that any of the data presented here is previous art, pertinent to the invention being claimed at this time, or that any publication, whether explicitly or implicitly.
Tuberculosis (TB) is an infectious disease that is a long-term threat to human health, the causative agent of which is mycobacterium Tuberculosis, which is infected in about one third of the world's population. According to the statistics of the world health organization, about 1000 million new tuberculosis cases are shared in 2017 all over the world, and about 160 million people die of tuberculosis. Therefore, tuberculosis remains a global health problem that threatens human health to date.

At present, the diagnosis of tuberculosis mainly depends on the examination of pathogens, and the common methods are smear staining microscopy, separation culture, immunological diagnosis, molecular biological diagnosis and the like. Wherein, the isolation culture method is the current gold standard for diagnosing tuberculosis, but the culture needs 4 to 8 weeks, thereby delaying clinical diagnosis and treatment.

The smear staining microscopy method is simple and rapid to operate, but the conventional method has low sensitivity and poor specificity. The immunological diagnosis has poor specificity and high false positive rate due to the cross of the existing antigen or antibody and other microorganisms.

Fluorescence imaging is a type of non-invasive imaging technique that can help visualize biological processes taking place in a living organism. Images can be produced from a variety of methods including: microscopy, imaging probes, and spectroscopy. Fluorescence itself is a form of luminescence that results from matter emitting light of a certain wavelength after absorbing electromagnetic radiation. Molecules that re-emit light upon absorption of light are called fluorophores. Fluorescence imaging photographs fluorescent dyes and fluorescent proteins to mark molecular mechanisms and structures. It allows one to experimentally observe the dynamics of gene expression, protein expression, and molecular interactions in a living cell. It essentially serves as a precise, quantitative tool regarding biochemical applications.

To overcome the drawbacks existing smear techniques, the present disclosure relates to device identify and process the fluorescence images of Mycobacterium tuberculi (TB) bacteria with appropriate staining and using software, useful to detect TB compare to conventional techniques also cost wise very economical.
Object of the Invention
The primary object of the invention is to develop a device using principle of fluorescence imaging of Mycobacterium tuberculi (TB) bacteria for easy detection with economic significance.
The secondary objective of the invention is that the device is fluorescence imaging preferably embodied with light source for illumination, fluorescent dye, Graphic User Interface (GUI) software, hardware, microscope objective and battery, effectively develops fluorescence images.
The another objective of the invention is that the fluorescence microscopy device analyses the fluorescence images developed using fluorescent dye on glass slide and illuminated with blue light automatically counted from the field of view of microscopic objective.
Summary of the Invention

The present invention relates to portable fluorescence microscopy device preferably utilizes microscopic glass slide preparation using fluorescent dye, illuminating with light source and observing through microscope objective, automatically counted Mycobacterium tuberculi (TB) bacteria to detect TB.
A device for detecting Mycobacterium tuberculi (TB) bacteria detection comprises a portable device of size 26.3 cm x 13.5 cm x 10.5 cm characterized in that a blue light source for illumination, a fluorescent dye, a Graphic User Interface (GUI) software, hardware, a microscope objective and a battery with USB ports herein a patients sputum smeared on a microscope glass slide, staining the glass slide with appropriate fluorescent dye like Auramine O and illuminating it with blue light, observing/ viewing the stained Mycobacterium tuberculi bacteria from microscope objective, finally counting the Mycobacterium tuberculi bacteria automatically using Graphic User Interface (GUI) software effectively and efficiently. The device is economical and user friendly compare to conventional fluorescence microscope.

One of the preferred embodiments of the present invention is to prepare the glass slide by smearing with sputum, staining it with fluorescent dye Auramine O, further illuminated using blue light to generate fluorescence images of TB bacteria.

One of the preferred embodiments of the present invention is that the illuminated fluorescence images observed through field view of microscope objective.

One of the preferred embodiments of the microscopic views of fluorescence images of Mycobacterium tuberculi (TB) bacteria automatically processed, and integrated using GUI software to identify and confirm the presence of TB bacteria.

Brief Description of Drawings

The following thorough explanation of the various aspects of the invention, taken in conjunction with the corresponding drawing that represents various aspects and other features of the disclosure invention.
Figure 1: Flow chart of method to operate the device

Detailed Description of the Invention

The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration through explanation and figures for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the ingredients described without departing from the scope of the invention.
The use of “including”, “comprising” or “having” variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.
As fluorescence-based optical techniques are sensitive to modest morphological and biochemical changes as the disease progresses, they may be used for early diagnosis of diseases. Over the past few decades, a variety of optical approaches have been employed for the early diagnosis of various types of TB. Of these, fluorescence spectroscopy has separately emerged as the most successful and has been extensively investigated by researchers. This method is less time-consuming and has good sensitivity and specificity. Due to their high cost and large number of components, these heavy systems appear to be very difficult to transfer from the lab to the clinic or for commercial application. But there isn't a single integrated device that can detect the fluorescence images of bacteria observed through microscope objective has major application in histopathology of diseases. Thus there is time based need and requirement for the detection of TB can signify a reliable, user-friendly, and reasonably priced device.

Thus, the present portable fluorescence microscopy device preferably utilizes microscopic glass slide preparation using fluorescent dye, illuminating with light source and observing through microscope objective, automatically counted Mycobacterium tuberculi (TB) bacteria to detect TB.
A device for detecting Mycobacterium tuberculi (TB) bacteria detection comprises a portable device of size 26.3 cm x 13.5 cm x 10.5 cm characterized in that a blue light source for illumination, a fluorescent dye, a Graphic User Interface (GUI) software, hardware, a microscope objective and a battery with USB ports herein a patients sputum smeared on a microscope glass slide, staining the glass slide with appropriate fluorescent dye like Auramine O and illuminating it with blue light, observing/ viewing the stained Mycobacterium tuberculi bacteria from microscope objective, finally counting the Mycobacterium tuberculi bacteria automatically using Graphic User Interface (GUI) software effectively and efficiently. The device is economical and user friendly compare to conventional fluorescence microscope.
Preferred embodiments of a fluorescence imaging tool for oral cavity
i) Main Housing/ Hardware: The body of fluorescence microscopy device emobodied with hardware configured with light source for illumination, fluorescent dye, Graphic User Interface (GUI) software, microscope objective and battery with USB ports. The fluorescence microscopy device has size of Length, 26.3 cm x Width, 13.5 cm x Height, 10.5 cm and Weight of 2.6 kg.
ii) Microscopic Glass Slide: Smearing the sputum on the glass slide, staining the prepared microscopic slide with fluorescent dye, herein Auramine O used a staining reagent followed with illuminating said glass slide blue light source, herein fluorescent images of TB bacteria are generated.
iii) Microscope Objective: The prepared slides are observed from the field view of suitable microscopic objective to locate the fluorescence images of Mycobacterium tuberculi (TB).
iv) Graphic User Interface (GUI) software: The fluorescence microscopic images TB bacteria can be automatically processed, developed and integrated using GUI software in real time to confirm the presence of Mycobacterium tuberculi (TB) effectively.
v) Battery: The present device works on the conventional batteries, specifically used in laptops, embodied with two USB ports into the main housing of the device.

Table no. 01: Preferred embodiments of the device

Sr No. Name of Embodiments Role/ Application
01 Main Housing /Hardware Configured various components of device with size; Length, 26.3 cm x Width, 13.5 cm x Height, 10.5 cm and Weight of 2.6 kg.

02 Blue light source Emits the desired wavelength light for illumination to produce fluorescence effect to detect TB bacteria
03 Fluorescent dye Detection of fluorescence signals and conversion it into fluorescence images
04 Graphic User Interface (GUI) software Automatic processing and integration of fluorescence images
05 Microscope objective Viewing Fluorescence images of TB bacteria
06 Battery with USB ports To provide the power to operates the device effectively.

Steps involved in the method to operate the device

i) Preparation of Microscopic Glass Slide: The sputum sample is smeared on to the glass slide, followed with staining with suitable fluorescence stain preferably Auramine O.

ii) Emitting and observing the glass slide: The prepared glass slide is exposed to blue light for illumination to produce fluorescence effect and observing through microscope objective to observe Mycobacterium tuberculi (TB) bacteria.

iii) Automatic Processing of the Fluorescence Images: The generated fluorescence microscopic images of TB bacteria are processed and developed automatically using Graphic User Interface (GUI) software in real time with speedy analysis of images to draw the clinical inference. (Table No. 1)

Method to operate the device
Smearing the sputum on the glass slide, staining the prepared microscopic slide with fluorescent dye of Auramine O as a staining reagent followed with illuminating said glass slide using blue light source, to form fluorescent images of TB bacteria; observing/ viewing the stained Mycobacterium tuberculi bacteria from the field view of suitable microscopic objective to locate the fluorescence images of Mycobacterium tuberculi (TB) bacteria; processing the fluorescence microscopic images of TB bacteria automatically using GUI software further developed and integrated in real time to confirm the presence of Mycobacterium tuberculi (TB) effectively. (Table No. 1 and Figure No. 1)
Example 1
Smearing the sputum on the glass slide like conventional method to observe the TB bacteria, herein the smeared glass slide is stained with suitable fluorescence staining reagent. The present device utilizes Auramine O as a staining reagent to locate the TB bacteria effectively which can be observed from the field view of suitable microscopic objective without using GUI software to confirm the presence of Mycobacterium tuberculi (TB) effectively
Example 2
Smearing the sputum on the glass slide, staining the prepared microscopic slide with fluorescent dye of Auramine O as a staining reagent followed with illuminating said glass slide using blue light source, to form fluorescent images of TB bacteria; observing/ viewing the stained Mycobacterium tuberculi bacteria from the field view of suitable microscopic objective to locate the fluorescence images of Mycobacterium tuberculi (TB) bacteria; processing the fluorescence microscopic images of TB bacteria automatically using GUI software further developed and integrated in real time to confirm the presence of Mycobacterium tuberculi (TB) effectively.

Scope of the Invention

Existing technologies used to detect Tuberculosis (TB) has limitations so overcome the loopholes of existing technologies the present device develop using Graphic User Interface (GUI) software and a hardware embodied with a light source runs through conventional battery of laptop or computer through configured two USB ports, effectively utilizes the process, herein patients sputum smeared on a microscope glass slide, staining the glass slide with appropriate fluorescent dye like Auramine O and illuminating it with blue light which automatically counts Mycobacterium tuberculi bacteria effectively and efficiently rapid detection; compare to conventional technique the device signify the economical benefit due to low costing configuration can be beneficial to TB patients in future.

It is to be understood that the present invention is not limited to the embodiments described above, it should be clear that various modifications and alterations can be made along with various features of one embodiment included in other embodiments, within the scope of the present invention.
, Claims:We claim,
1- A fluorescence microscopy device for Mycobacterium tuberculi (TB) bacteria detection comprising a portable device characterized in that a blue light source for illumination, a fluorescent dye, a Graphic User Interface (GUI) software, hardware, a microscope objective and a battery with USB ports used to rapid detection of Mycobacterium tuberculi (TB) bacteria through automatic count.
2- The fluorescence microscopy device for TB detection as claimed in claim 1, the fluorescent dye is Auramine O.
3- The fluorescence microscopy device for TB detection as claimed in claim 1 is of size; Length, 26.3 cm x Width, 13.5 cm x Height, 10.5 cm and Weight of 2.6 kg.
4- The fluorescence microscopy device for TB detection as claimed in claim 1, operates through following steps;
i) smearing the patients sputum on microscope glass slide;
ii) staining the glass slide using Auramine O fluorescence dye;
iii) illuminating it with blue light source;
iv) observing/ viewing the stained Mycobacterium tuberculi bacteria from microscope objective; and
v) counting the Mycobacterium tuberculi bacteria automatically using Graphic User Interface (GUI) software.