Description:FIELD OF INVENTION:
The present invention relates to the field of preservation of genetic material/ any specimen.
Particularly, the present invention relates to a composition and a process for preserving genetic material/ any specimen of the same.

BACKGROUND OF THE INVENTION:
In the realm of molecular biology, the preservation and analysis of genetic material/ any specimen are pivotal for a myriad of applications including research, diagnostics, and personalized medicine. Existing preservation methods often encounter limitations in terms of stability, compatibility with molecular techniques, and user-friendliness.
Malihe Pooresmaeil et al; 25 October 2021, discloses nontoxic materials with natural origin are promising materials in the designing and preparation of the new drug delivery systems (DDSs). Today's, citric acid (CA) has attracted a great deal of attention because of its special features; green nature, biocompatibility, low price, biodegradability, and commercially available property. So, CA has been employed in the preparation of the various platforms to induce a suitable property on their structure. Recently, several research groups investigated the CA-based platforms in different forms like tablets, dendrimers, hyperbranched polymers, (co)polymer, hydrogels, and nanoparticles as efficient DDSs. By considering an increasing amount of published articles in this field, for the first time, in this review, an overview of the published works regarding CA applications in the design of various DDSs is presented with a detailed and insightful discussion.

Ruihua Tang et al, discloses rapid nucleic acid testing (NAT) technology as an effective tool for point-of-care testing (POCT), has been widely used for health, food additive, and environmental pollution monitoring. Nucleic acid extraction (NAE) is a vital first step of NAT technology, including sample lysis, washing and elution. At present, storage of sample lysis solution for rapid NAE methods is expensive, complex and environmentally unfriendly. To address these drawbacks, a low-cost, rapid, simple, and portable material is urgently needed. Herein, we developed a pH-responsive carboxymethyl chitosan/sodium alginate/polyethylene glycol (CMCS/SA/PEG) composite hydrogel that works as a physical crosslink, then used it to store sample lysis solutions for the dry immersion method for NAE. Results showed that the CMCS/SA/PEG6000 composite hydrogel had large pore size (256.58?±?5.58 µm), good wet strength (282.3 Kpa), excellent swelling rate (706.91?±?6.69%), high loading capacity (90.46?±?1.13%), good degradation capacity (77.87?±?1.45%), and rapid response time (15 s). The CMCS/SA/PEG6000 composite hydrogel could be loaded into a syringe and combined with filter paper to function as a simple NAE device. Efficiency of lysis of nucleic acid of saliva, whole blood, E.coli and S.aureus was 20.71?±?0.12%, 9.59?±?0.12%, 16.57?±?0.19%, and 29.16?±?0.07%, respectively. Also, nucleic acid was successfully extracted from a 30 µL sample of saliva so the method has potential to be integrated into other platforms for NAT.

Patit P. Kundu et al, Natural Polymeric Vectors in Gene Therapy discloses Viral vectors, liposomes, and synthetic polymeric vectors are the most widely used gene carriers in gene therapy. Among the natural polymers, chitosan and their derivatives are the strong candidates as nonviral vectors in gene therapy due to their reduced cytotoxicity, biodegradability, excellent biocompatibility, and low immunogenicity character. It has been successful in oral and nasal delivery due to its mucoadhesive property. Apart from chitosan, gelatin, collagen, arginine, and alginate are also used as gene carriers. The natural polymers can be tailored through ligand conjugation, crosslinking and many other modifications with its reactive sites and used for a wide range of clinical applications. Due to the gene carrier ability of natural polymers, they can play an important role in the field of regenerative medicines. This chapter highlights the present and past research on natural polymers as nonviral vectors in gene therapy.

Vaidya, A. A., Design, synthesis and evaluation of polymers for affinity-based enzyme separations discloses A wide range of techniques have been developed for the separation and recovery of different biomolecules. Amongst these, the affinity-based techniques viz. affinity chromatography, affinity ultrafiltration and affinity two-phase aqueous extraction are attractive as they provide high specificity and selectivity during separation as compared to the conventional methods. Although selective, these techniques are beset with major shortcomings. To name a few, fouling of the membranes in affinity ultrafiltration, low capacity and flow rate limitations in affinity chromatography and contamination of the polymeric phase with final product in two-phase extraction. The affinity precipitation technique overcomes many of the problems associated with membrane filtration and affinity chromatography. It offers ease of scale up, concentration and purification, which could be achieved in a single step. It is amenable to continuous operation and the affinity ligand can be recycled. A large number of enzymes separated using this technique. With continued investigations, many shortcomings of affinity precipitation too were realized. It suffers from limited stability of many natural affinity ligands, decrease in the affinity of ligand when incorporated in the polymer due to crowding effect, and steric hindrance posed by the high molecular weight polymers. The present investigation was undertaken to design and synthesize new affinity polymers that would overcome the crowding effect and enhance the ligand-enzyme binding in affinity thermos precipitation process. To adapt and demonstrate this methodology for the recovery of a commercially valuable enzyme, lysozyme was selected as a candidate. A comparative analysis of recovery of lysozyme by acidic thermoprecipitating polymers versus affinity based synthetic/natural ligands has been done. In the recent past, molecular imprinting technique has been employed in various bioseparations. In this, secondary valance interactions such as hydrogen bonding, ionic and hydrophobic interactions are exploited not only during synthesis of an imprinted polymer but also during rebinding studies. Since only weak interactions are involved in the rebinding of the desired molecule, the selectivity and capacity of such imprinted receptors is often low. In order to improve on this the enzyme-affmity ligand interactions are exploited during synthesis of molecularly imprinted polymers.

The present composition addresses these challenges by presenting a universal solution for the preservation and analysis of diverse biological samples, thereby opening up new vistas in genetic research to promote public health.
Given the above, there arise a need to develop a composition which overcome the problem existing in the art.

OBJECTIVE OF THE INVENTION:
The main objective of the present invention is to develop a for preserving genetic material / any specimen.
Another object of the present invention is providing a process for preserving genetic material/ any specimen.

SUMMARY OF THE INVENTION:
Accordingly, the present invention provides a composition for the preservation of genetic material/ any specimen comprising TRIS- Cl buffer; EDTA; Guar Gum/kappa carrageenan; Natural Hydrogel; Citric Acid; Guanidium thiocyanate;
Sodium chloride (0.1nM – 1mM); Sodium/Potassium mono hydrogen phosphate;
Sodium/Potassium di hydrogen phosphate; and Basic blue/methylene Blue/tolueidine blue/bromothymol/ / phenolphthalein and/or universal indicator.
In an embodiment, the present invention provides that the TRIS-Cl buffer ranges from 20mM – 120mM having pH in the range of 7-9 and the Guar Gum/kappa carrageenan ranges from 0.001 – 0.01% (V/W).
In an embodiment, the present invention provides that the EDTA ranges from 0.3mM - 55mM with a pH ranging from 7-9 and the Natural Hydrogel ranges from 0.0001 – 0.001% (V/W) and the citric Acid ranges from 0.01mM – 10mM.
In an embodiment, the present invention provides that the Sodium chloride ranges from 0.1nM – 1mM and the Sodium/Potassium mono hydrogen phosphate ranges from 0.02mM – 0.5mM.

In an embodiment, the present invention provides that the Sodium/Potassium di hydrogen phosphate ranges from 0.2mM – 0.1mM and the Basic blue/methylene Blue/tolueidine blue/bromothymol// phenolphthalein and/or universal indicator ranges from 0.1 – 0.0001% (V/W).

In an embodiment, the present invention provides a method for preserving genetic material / any specimen from diverse biological samples, wherein the process comprises collecting a biological sample, preserving the sample in the composition of the present invention as claimed in claim 1, and storing the preserved sample under appropriate conditions for downstream molecular analyses.
In an embodiment, the present invention provides that the preserved genetic material/ any specimen maintains DNA integrity, protein, metabolites for over 5 years at -80°C, extending to 5-6 months at -20°C, and 30 days at 4°C.
In an embodiment, the present invention provides that the preserved genetic material exhibits stability of specific stable RNAs for up to 5 years at -80°C and mRNA for min 3 months at -80°C.
In an embodiment, the present invention provides that the composition preserves any kind of specimen or biological material including blood for further analysis and the composition is a pH indicator base transport and preservation medium to check the specimen state while collecting as well as during and after preservation.
In an embodiment, the present invention provides that the specimen in the composition does not undergo any further lysis for downstream biological assay/process and the composition transports any specimen at room temperature to any place within 7 day of collection without cold chain to transport specimen.

DETAILED DESCRIPTION:
To promote an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof. Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment”, “in another embodiment”, and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises...a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting. Embodiments of the present invention will be described below in detail concerning the accompanying drawings. fully crystalline, and exhibit impressive mechanical properties and tunable surface chemistries.

The present invention develops innovative solution tailored to preserve genetic material/ any specimen from a wide spectrum of biological samples, encompassing animal, human, environmental, tissue, cancer specimens, stool, food, blood, organs and beyond. It sustains DNA integrity over prolonged periods under various storage conditions, ensuring the stability of nucleic acids, protein & metabolite integrity and for downstream molecular analyses. The composition of the present invention harmonizes seamlessly with an array of molecular techniques including PCR, RT-PCR, sequencing, metagenomic studies, OMICS studies, etc., thereby constituting a versatile tool for blueprint of genetic research.
The composition of the present invention stands as a pioneering formulation meticulously engineered to revolutionize the preservation and analysis of genetic material. Crafted with precision, the composition of the present invention comprises components meticulously tailored to ensure the stability, integrity, and versatility of nucleic acids, protein and metabolites across a diverse array of biological samples. At its core lie essential components including guanidine thiocyanate and its derivatives, EDTA, sodium/potassium monohydrogen phosphate, sodium/potassium dihydrogen phosphate, sodium chloride, hydrogel, Guar Gum, Tris buffer, citric acid, glycerol, and a basic dye/pH indicator. Each constituent plays a pivotal role in enhancing the efficacy and multifunctionality of the composition of the present invention in preserving genetic material / any specimen while facilitating health assessment. The integration of guanidine thiocyanate and its derivatives within the composition of the present invention serves as a cornerstone, disrupting cellular structures and denaturing protease and proteins, thereby ensuring the preservation of nucleic acids, proteins, and metabolites within biological samples. This key component is instrumental in maintaining the stability of genetic material/ any specimen over prolonged periods, even under varying storage conditions. EDTA, serving as a chelating agent, finds its place within the composition of the present invention to sequester divalent cations, such as magnesium ions, essential cofactors for nucleases. By effectively chelating these ions, EDTA inhibits the activity of nucleases, thereby safeguarding the integrity of nucleic acids from enzymatic degradation. Sodium/potassium monohydrogen phosphate and sodium/potassium dihydrogen phosphate act as buffering agents, ensuring the pH of the composition of the present invention remains within an optimal range for nucleic acid, proteins and metabolites integrity and stability. These buffer systems mitigate pH fluctuations, thereby preserving the integrity of genetic material / any specimen during sample processing and storage.

Furthermore, sodium chloride contributes to maintaining osmotic balance and stabilizing cellular component, bolstering the preservation of genetic material integrity and nucleic acid stability within the composition of the present invention. Synergistically, Tris buffer and its derivative and citric acid fine-tune the pH of the composition of the present invention, optimizing conditions for nucleic acid preservation, killing microbes/any living organism/prokaryote and eukaryotes cells immediately while ensuring the functionality of the integrated dye/pH indicator. The incorporation of a basic dye/pH indicator, such as methylene blue/ toluidine blue, /bromothymol blue/ phenolphthalein and/or universal indicator, represents a hallmark feature of innovation within the composition of the present invention. This dye/pH indicator imparts dual functionality, enabling both diagnostic and preservation purposes. Its unique capability to detect patients' health conditions through visual inspection with the naked eye obviates the need for complex downstream molecular biological techniques. Dye changes the color based on the pH of the specimen, at lower pH, it is yellow, neutral pH it is green and in basic pH, it shows blue color means patient physiological condition can be checked through naked eyes. Additionally, the dye/pH indicator is ingeniously engineered to inhibit specific protease inhibitors, thus preventing the digestion of nucleic acids and ensuring their integrity and preservation within the biological sample. In summary, the composition of the present invention epitomizes the convergence of advanced molecular biology principles and innovative formulation design. Its multifunctionality, encompassing both diagnostic and preservation functionalities, underscores its significance as a groundbreaking innovation in the field of molecular biology. With vast potential to catalyze advancements in research, diagnostics, and personalized medicine, The composition of the present invention stands as a comprehensive solution poised to redefine genetic material/ any specimen preservation and analysis.

The composition of the present invention acts as a catalyst for groundbreaking discoveries in molecular biology research, empowering scientists to explore novel avenues in genetics, genomics, and related domains. Accordingly, the composition of the present invention facilitates precise and dependable genetic analyses for disease diagnosis, prognosis, and treatment selection, thereby contributing to advancements in public healthcare. The composition of the present invention supports personalized medicine approaches by preserving genetic material/ any specimen for tailored treatment strategies and therapeutic interventions. Environmental Studies: The composition of the present invention enables the analysis of genetic material/ any specimen from environmental samples, offering insights into biodiversity, ecological dynamics, and environmental health.

The composition of the present invention heralds a paradigm shift in genetic material / any specimen preservation with high integrity and analysis, offering a universal solution characterized by unparalleled stability, compatibility, and user-friendliness. By unlocking the future of genetic research, the composition of the present invention empowers scientists, clinicians, and researchers to transcend the confines of conventional molecular biology and embark on a journey of discovery in genetics and genomics.
The following examples define the invention by way of illustration which does not limit the scope of the invention.
Example 1:
The preserved genetic material/ any specimen is compatible with a wide range of molecular techniques including PCR, RT-PCR, sequencing, metagenomic studies, and more.
The preserved genetic material/ any specimen enables a broad spectrum of genetic studies including OMICS, metabolomics, proteomics, NGS, PCR, RT-PCR, metagenomics, WGS, shotgun sequencing, and sangar method applications.
The preserved genetic material/ any specimen eliminates the need for sample lysis, thereby simplifying sample handling and processing procedures.
The preserved genetic material / any specimen possesses the capability to neutralize strong pathogens immediately before analysis, making it suitable for disease diagnosis and personalized medicine applications.
The preserved genetic material / any specimen yields 2.5 to 3 times higher nucleic acid extraction compared to commercially available specimen collection kits.
The formulation includes a dye/pH indicator capable of detecting patients' health conditions through naked eyes without the need for downstream molecular biological techniques.
The dye/pH indicator is innovatively designed to inhibit specific protease inhibitors, thereby preventing the digestion of nucleic acids and facilitating the extraction of maximum amounts of nucleic acids for preservation, analysis, and further applications
The preserved genetic material/ any specimen ensures long-term preservation under environmental conditions ranging from -60°C to +50°C for over 5 years.
The preserved genetic material/ any specimen facilitates transportation at room temperature within 7 - 15 days, thus making it suitable for genomic and metagenomic studies across diverse settings.

Advantages:
1) Universal Applicability: The composition of the present invention is adept at preserving genetic material from diverse biological samples, thereby offering a universal solution catering to the needs of researchers and clinicians alike.

2) Long-Term DNA Preservation: The composition of the present invention conserves DNA integrity for over 3 years at -80°C, extending to 5-6 months at -20°C, and 7 days at 4°C, thus ensuring the preservation of genetic material for prolonged periods.
3) RNA Stability: The composition of the present invention exhibits stability of specific stable RNAs for up to 2 years when stored at -80°C, thereby guaranteeing the preservation of RNA molecules for subsequent analyses.

4) Molecular Techniques Compatibility: Nucleic acids, protein and metabolites preserved in the composition of the present invention are compatible with a diverse range of molecular techniques including PCR, RT-PCR, sequencing, metagenomic studies, etc., facilitating comprehensive genetic analyses.

5) Versatility: The composition of the present invention enables a wide spectrum of genetic studies encompassing OMICS, metabolomics, proteomics, NGS, WGS, PCR, RT-PCR, metagenomics, WGS, shotgun sequencing, and sangar method applications.

6) User-Friendly Design: The composition of the present invention streamlines laboratory workflows and is compatible with a plethora of DNA and RNA extraction kits commercially available in the market, thereby enhancing user convenience.

7) Quality Assurance: The composition of the present invention undergoes stringent quality control measures to ensure consistent performance, thereby furnishing researchers with reliable results.

8) Transportation at Room Temperature: The composition of the present invention facilitates the transportation of any specimen at room temperature within first 2- 7 days, rendering it suitable for genomic and metagenomic studies across diverse settings.

9) No Sample Lysis Required: The composition of the present invention obviates the need for sample lysis once preserved, simplifying sample handling and processing procedures.
10) Microbe Neutralization: The composition of the present invention possesses the capability to neutralize any/strong pathogens before analysis, thereby proving invaluable for disease diagnosis, understanding origins, searching for disease-X, antimicrobial resistance, and personalized medicine applications.
11) The buffer media is stable for 5 years at room temperature without any specimen in it.
, Claims:We Claim:
1. A composition for the preservation of genetic material/ any specimen comprising:
a. TRIS- Cl buffer;
b. EDTA;
c. Guar Gum/kappa carrageenan;
d. Natural Hydrogel;
e. Citric Acid;
f. Guanidium thiocyanate;
g. Sodium chloride (0.1nM – 1mM);
h. Sodium/Potassium mono hydrogen phosphate;
i. Sodium/Potassium di hydrogen phosphate; and
j. Basic blue/methylene Blue/tolueidine blue/bromothymol/ phenolphthalein and/or universal indicator.
2. The composition as claimed in claim 1, wherein the TRIS-Cl buffer ranges from 20mM – 120mM having pH in the range of 7-9 and the Guar Gum/kappa carrageenan ranges from 0.001 – 0.01% (V/W).
3. The composition as claimed in claim 1, wherein the EDTA ranges from 0.3mM - 55mM with a pH ranging from 7-9 and the Natural Hydrogel ranges from 0.0001 – 0.001% (V/W) and the citric Acid ranges from 0.01mM – 10mM.
4. The composition as claimed in claim 1, wherein the Sodium chloride ranges from 0.1nM – 1mM and the Sodium/Potassium mono hydrogen phosphate ranges from 0.02mM – 0.5mM.

5. The composition as claimed in claim 1, wherein the Sodium/Potassium di hydrogen phosphate ranges from 0.2mM – 0.1mM and the Basic blue/methylene Blue/tolueidine blue/bromothymol ranges// phenolphthalein and/or universal indicator from 0.1 – 0.0001% (V/W).

6. A method for preserving genetic material / any specimen from diverse biological samples, wherein the process comprises:
a) collecting a biological sample,
b) preserving the sample in the composition of the present invention as claimed in claim 1, and
c) storing the preserved sample under appropriate conditions for downstream molecular analyses.
7. The composition of the present invention as claimed in claim 1, wherein the preserved genetic material/ any specimen maintains DNA integrity, protein, metabolites for over 5 years at -80°C, extending to 5-6 months at -20°C, and 30 days at 4°C.
8. The composition of the present invention as claimed in claim 1, wherein the preserved genetic material exhibits stability of specific stable RNAs for up to 5 years at -80°C and mRNA for min 3 months at -80°C.
9. The composition of the present invention as claimed in claim 1, wherein the composition preserves any kind of specimen or biological material including blood for further analysis and the composition is a pH indicator base transport and preservation medium to check the specimen state while collecting as well as during and after preservation.
10. The composition of the present invention as claimed in claim 1, wherein the specimen in the composition does not undergo any further lysis for downstream biological assay/process and the composition transports any specimen at room temperature to any place within 7 day of collection without cold chain to transport specimen.