Mail type sperm analysis kit and use method thereof

Abstract

The present invention discloses a dual vial system (10), kit (100) and methods of use thereof, specifically designed for mailing a seminal fluid analysis kit, intended to properly preserve a seminal fluid sample. The core component of the system (10) is a double-vial kit (100) containing three main parts: a first vial (105) for collecting a semen sample of a subject; the second vial (110) is then preloaded with a specific volume of stabilizing medium (120); furthermore, a transfer device (115) is provided for transferring a specified portion of the semen sample from the first vial (105) to the second vial (110). The capacity of this delivery device (115) is precisely designed to ensure that a portion of the semen sample is transferred into the second vial (110) containing three times its volume of stabilizing medium (120) to achieve an effective dilution of the semen. Therefore, by means of the double-bottle kit (100), the activity of the semen sample is maintained for 72 hours, and semen analysis can be performed within 72 hours after the semen is stored in the stable medium.

Description

TECHNICAL FIELD

[0001] The present invention relates generally to the field of biological fluid collection, storage, and analysis. More particularly, the present invention relates to a mail-in sperm analysis kit and methods of use thereof. BACKGROUND

[0002] In the field of male fertility diagnosis, sperm analysis plays a pivotal role in providing valuable data for a deeper understanding of reproductive health. However, the accuracy and reliability of the diagnosis face significant challenges due to the inconsistency of ejaculate volume. According to the International Society for Sexual Medicine and the World Health Organization (WHO), there is a significant variation in ejaculate volume among individuals, ranging from 1.25 to 5 milliliters, with a median of 3.7 milliliters. This variability poses a significant obstacle to standardization of sperm analysis, especially in the context of home testing or mail-in diagnostic kits. Additionally, the short survival time of sperm further exacerbates the difficulty of standardization. Once sperm is outside the body, it rapidly loses motility and can even die within a few minutes. After just one hour, there are very few viable sperm left for detection. This undoubtedly presents significant logistical challenges for the handling and transportation of semen samples, particularly in situations where samples cannot be promptly delivered to a laboratory for testing.

[0003] Current common methods rely on in vitro fertilization (IVF) media or cryoprotective agents as transport or stabilization media for semen samples. These protocols require users to mix the transport medium with the semen sample in the same vial to ensure sperm viability during transport. However, these methods all have a key problem, which is the variability of dilution concentration. Dilution is not just a simple mathematical ratio problem, it is also closely related to the biophysical properties of the semen sample. For example, if individuals with different ejaculate volumes, such as 2 milliliters and 7 milliliters, mix their semen samples with a fixed volume of 12 milliliters of transport medium, the resulting dilution ratio will be significantly different. This inconsistency in dilution ratio can affect the reading of sperm concentration and motility, leading to errors in the diagnosis process.

[0004] Laboratories have attempted to use centrifugation techniques to address standardization challenges after receiving samples. However, although centrifugation can effectively separate sperm from other components, it cannot repair potential damage or errors caused by improper initial dilution or insufficient transport medium. This method not only increases the complexity and cost of the diagnostic process, but is also not suitable for home testing or mail-in diagnostic kits. Existing solutions all have one or more of the above limitations. Therefore, we still need a diagnostic kit that can conveniently maintain the quality of semen samples for a long time for subsequent testing. SUMMARY

[0005] It is an object of the present invention to provide an improved technical solution aimed at addressing the challenges faced by the prior art in preparing a test kit capable of maintaining the quality of a semen sample for a long period of time.

[0006] It is another object of the present invention to provide a home or mail-in male fertility diagnostic kit capable of easily collecting and maintaining the quality of a semen sample for a long period of time for subsequent detection analysis.

[0007] It is yet another object of the present invention to provide a dual vial system and method for preserving a semen sample in a semen analysis kit.

[0008] It is yet another object of the present invention to describe a standardized procedure aimed at ensuring that the dilution concentration of a semen sample and its corresponding transport medium remains consistent in a home male fertility diagnostic kit.

[0009] It is another object of the present invention to provide a procedure capable of ensuring the accurate preparation of a semen sample for diagnostic analysis.

[0010] It is a further object of the present invention to ensure that the dilution ratio between a semen sample and a transport medium or stabilizing medium is stable, thereby improving the accuracy of semen sample detection.

[0011] It is a final object of the present invention to facilitate the conduct of various diagnostic analyses while allowing both the original semen sample and the homogenized mixture to be included in the detection package returned to the laboratory, while ensuring sample integrity.

[0012] To achieve the above objects of the present technical disclosure, in one aspect, there is provided a method for collecting and preserving a semen sample of a subject using a dual vial test kit aimed at prolonging the time activity of the sample. The method comprises the steps of: first collecting a pure semen sample of the subject in a first vial; subsequently transferring a predetermined amount of the semen sample from the first vial to a second vial containing a stabilizing medium to form a homogenized solution; and storing the homogenized solution to ensure that the semen sample is preserved in the stabilizing medium and is available for semen analysis for a predefined period of time while maintaining the semen activity for a predefined extended period of time. The predefined time can be up to 72 hours.

[0013] In certain embodiments, after transferring the predetermined amount of the semen sample from the first vial to the second vial, the method further comprises stirring the mixture of the semen sample and the stabilizing medium until it is completely homogenized.

[0014] In certain specific embodiments, the step of transferring the semen sample from the first vial to the second vial further comprises mixing the semen sample with the stabilizing medium in a ratio of 3:1 to form a mixture comprising three parts of the stabilizing medium and one part of the semen sample.

[0015] In certain embodiments, the method further requires storing the homogenized solution in the second vial at a temperature close to body temperature, i.e., between 36.1 degrees Celsius and 37.2 degrees Celsius.

[0016] In certain embodiments, the method further provides that the stabilizing medium should be maintained at a temperature range of 2 degrees Celsius to 12 degrees Celsius prior to mixing with the semen sample.

[0017] In certain embodiments, the stabilizing medium comprises one or more components selected from the group consisting of a pH buffer, an inorganic salt, an organic compound, and an amino acid having antioxidant properties. These components can be dissolved in water to prepare the stabilizing medium.

[0018] In certain embodiments, the method further requires storing the remaining semen sample in the first vial as a backup for transportation together with the second vial containing the homogenized solution.

[0019] Alternatively, a transfer device, such as a syringe, can be used to transfer the predetermined portion of the semen sample from the first vial to the second vial.

[0020] In another aspect, a system for collecting and preserving a semen sample from a subject for extended time of viability is also provided. The system comprises a dual-vial kit comprising a first vial for collecting the semen sample, a second vial containing a predetermined amount of a stabilizing medium, and a transfer device for transferring the semen sample from the first vial to the second vial, and the transfer device is designed to have a capacity sufficient to dilute a portion of the semen sample in the second vial with the stabilizing medium at a ratio of 3:1.

[0021] In another aspect, the present disclosure also provides a dual-vial kit for collecting, packaging, storing, and transporting a semen sample from a subject. The dual-vial kit comprises a first vial for collecting the semen sample from the subject, a second vial containing a predetermined amount of a stabilizing medium, and a transfer device for transferring a predetermined amount of the semen sample from the first vial to the second vial, and the transfer device is designed to have a capacity sufficient to dilute 1 part of the semen sample in the second vial with 3 parts of the stabilizing medium.

[0022] In some embodiments, the first vial and the second vial are designed to be sealable to ensure airtightness and leakproofness, thereby maintaining the integrity of the contents.

[0023] In certain embodiments, the dual-vial kit further comprises a label provided for the first vial and the second vial.

[0024] In some embodiments, the dual-vial kit further comprises a protective outer packaging for housing the first vial, the second vial, and the transfer device. In addition, the transfer device can be a syringe.

[0025] In some embodiments, the dual vial kit is also accompanied by an instruction manual for guiding the subject on how to collect, package, store and ship the semen sample.

[0026] The disclosed systems, kits and methods have the significant advantage of maintaining a consistent dilution concentration of the semen sample and its corresponding shipping medium in a home or mail-in male fertility diagnostic kit. In addition, the kits and methods of the present disclosure allow for the preservation of the semen sample for up to 72 hours. Thus, the kits and methods of the present disclosure allow for the accurate preparation of a semen sample for various diagnostic analyses while maintaining the integrity of the sample, thereby increasing the accuracy of the semen sample testing. Further, the kits and methods of the present disclosure allow for the simultaneous placement of the raw semen sample and its uniform mixture with the corresponding shipping medium into a return mail package for testing at a laboratory.

[0027] These and other aspects of the embodiments herein will be better appreciated and understood when considered in connection with the following description and accompanying drawings. It is intended that the specification and examples be considered as illustrative of the embodiments herein and not in limitation. Numerous other modifications and changes will be readily apparent to those skilled in the art having the benefit of this disclosure. Accordingly, the embodiments herein are not intended to be limited by the received examples but are to be accorded the widest scope.

[0028] The core and essential features of the present disclosure can be more readily understood when considered in connection with the following drawings, in which:

[0029] Fig. 1 An exemplary block diagram of a system for the collection, packaging, storage and shipping of a semen sample from a subject in accordance with the present disclosure is shown.

[0030] Fig. 2 An exemplary schematic of a dual vial kit in accordance with the present disclosure is shown.

[0031] Fig. 3 A flowchart of a method for the collection and preservation of a semen sample from a subject using a dual vial kit in accordance with the present disclosure is shown. DETAILED DESCRIPTION

[0032] With reference to the appended drawings, the features and functions of the systems, kits and methods of the present disclosure will be described in more detail. It should be noted that the terms used herein are for the purpose of describing particular embodiments and are not intended to limit the broad applicability of the present disclosure.

[0033] The detailed description set forth below is intended as a description of the presently preferred embodiment of the application, and is not intended to represent the only manner in which the application can be practiced. It is further understood that the use of relational terms such as first, second and third, and the like are used solely to distinguish one from another entity and do not require a particular sequence of appearance of the items. With specific reference to the drawings in

[0034] This embodiment is chosen and described to best explain the principles of the application and its practical application to enable others skilled in the art to best utilize the application in various embodiments and with various modifications as are suited to the particular use contemplated.

[0035] Reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with this embodiment is included in at least one implementation of the application. The appearances of the phrases "in one embodiment" or "in an embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

[0036] As previously mentioned, there is still a need for an improved technical solution to address the problem of non-uniform dilution of semen samples in a stabilizing medium due to variations in semen volume. The present application provides systems, kits, and methods for collecting, packaging, storing, and shipping semen samples from a subject. The kits and methods of the present application have significant advantages in ensuring uniform dilution concentration of semen samples and their corresponding shipping medium in a home fertility diagnostic kit or a mail-in fertility diagnostic kit. In addition, the kits and methods of the present application also allow for the preservation of semen samples for up to 72 hours. Thus, the kits and methods of the present application enable the accurate preparation of semen samples for various types of diagnostic analyses while ensuring sample integrity, thereby improving the accuracy of semen sample testing. Further, the kits and methods of the present application also allow for the inclusion of the original semen sample and a uniform mixture of the semen sample and its corresponding shipping medium in a return package for laboratory testing.

[0037] Several terms used herein are defined below:

[0038] "Semen sample" generally refers herein to an organic fluid secreted by the male gonads and other sex organs that has the ability to fertilize a female ovum.

[0039] "Subject" generally refers herein to an organism that contains genetic information that can be expressed. Such organisms can be mammals, including humans. In certain embodiments, the mammals can also be non-human. These non-human mammals can be genetically modified or naturally occurring. In certain embodiments, the organism can also be non-mammalian.

[0040] "Semen analysis" refers to a series of laboratory tests performed to assess male fertility.

[0041] "Pure semen sample" refers to a semen sample that is clean and free from contamination.

[0042] In this document, "stabilization medium" and "transport medium" are used interchangeably and refer to substances, solutions, or materials designed to maintain the integrity, activity, or stability of biological samples or materials during storage or transport. They are used to prevent degradation, damage, or alteration of biological components, ensuring that they remain in good condition for subsequent analysis or processing.

[0043] "Time-sensitive viability" refers to the ability of a biological material to maintain its survival, functionality, or activity over a specific period of time. It is a measure of whether an organism, cell, or biological material can maintain its integrity and functionality over a given time period.

[0044] "Extended time-sensitive viability" refers to the ability of a biological material to maintain its survival, functionality, or activity over a longer period of time.

[0045] "Vial" generally refers to a container used to store and transport liquids, powders, or other substances. Vials come in various sizes and materials, can be equipped with stoppers or caps for sealing, and provide a secure environment to protect the contents from contamination and external factors.

[0046] "First vial" refers to the container used to collect a pure semen sample.

[0047] "Second vial" refers to the container used to store the stabilization medium before the semen sample is mixed in, and the container used to store the homogeneous solution containing the stabilization medium and the semen sample after the semen sample is poured in.

[0048] "Kit" refers to a set of items, materials, or components combined together for a specific purpose.

[0049] "Two-vial kit" refers to a kit that contains two vials, which, along with other components or items, serve a specific purpose or function.

[0050] "Pre-determined volume," "pre-determined portion," and "pre-defined volume" all refer to a known quantity of a substance, solution, or material that is pre-set for a specific purpose, ensuring accuracy and reproducibility in scientific, industrial, or analytical applications.

[0051] "Transfer device" refers to an instrument or apparatus used to accurately transfer a substance from one container to another, such as a pipette, syringe, or similar instrument.

[0052] "Label" generally refers to an identifier, such as a label or sticker, affixed to a vial or other product in a kit package. The purpose of a label is to provide necessary details, instructions, warnings, or identification to more easily understand the nature of the item or its contents.

[0053] In this document, the term "protective overwrap" generally refers to an overwrap structure designed specifically to house the components or products of a kit.

[0054] In this document, the term "preservation" generally refers to an operation or process performed to maintain the quality, state, or existence of a substance, solution, or material over time.

[0055] The term "storage" in this document generally refers to the act of holding, placing, or maintaining an item, substance, solution, or material in a particular location for a period of time. The primary purpose of storage is to ensure the integrity of the item, substance, solution, or material.

[0056] The term "collection" in this document refers to the gathering or accumulation of samples or representative portions of materials, substances, mixtures, or solutions for further analysis, examination, or study.

[0057] In this document, the term "packaging" generally refers to the operation or process of enclosing a substance, solution, or material in a container or vial to protect them.

[0058] The term "transport" in this document generally refers to the act of moving a collected sample, material, or substance from one location to another.

[0059] The term "dilution ratio" in this document generally refers to the proportional relationship between a first substance, material, or solution and a second substance, material, or solution when preparing a solution of the desired concentration.

[0060] In this document, the term "agitation" generally refers to the act of vigorously stirring or shaking a substance or mixture to promote mixing, dispersion, or homogenization.

[0061] The term "homogenized solution" in this document refers to a mixture in which the components are uniformly distributed.

[0062] The term "sperm motility" in this document is generally defined as the percentage of live sperm in a semen sample.

[0063] The term "near body temperature" in this document refers to a temperature range close to the average internal temperature of the human body.

[0064] The term "pH buffer" in this document generally refers to a substance or mixture of substances that can help maintain the pH (acidity or alkalinity) of a solution relatively stable when acid or base is added.

[0065] The term "inorganic salt" refers generally herein to a compound composed of a positively charged cation and a negatively charged anion, which compound is overall electrically neutral.

[0066] The term "organic compound" refers generally herein to a chemical compound that contains one or more carbon atoms covalently bonded to other elemental atoms.

[0067] The term "amino acid with antioxidant properties" refers herein to those amino acids that are capable of neutralizing or reducing oxidative stress and preventing damage caused by free radicals within a biological or chemical system.

[0068] As used herein, "one or more" generally refers to at least one, but can also mean more than one.

[0069] Reference will now be made to the drawings wherein like numerals refer to like components throughout the several figures, and Figs. 1 to 3 exemplary embodiments.

[0070] Fig. 1 An exemplary block diagram of a system 10 designed in accordance with the present disclosure for collecting, packaging, storing and shipping a semen sample from a subject is shown. The system 10 includes a dual vial kit 100 specifically designed for collecting, packaging, storing and shipping a semen sample from a subject. In certain embodiments, the subject is a human, and thus the semen sample is human semen. In addition, the system 10 can include a diagnostic kit for analyzing the semen sample to assess male fertility using methods well known to those skilled in the art. Fig. 2An exemplary schematic of a dual vial set 100 according to the present disclosure is presented. The dual vial set 100 is a collection, packaging and shipping solution specifically designed for semen samples. In another embodiment, the dual vial set 100 is used for the collection, packaging and shipping of human semen samples. The dual vial set 100 contains two separate vials, a first vial 105 and a second vial 110, each of which is sealed with a specially designed cap or rubber stopper to ensure airtight and leakproof seal, thereby ensuring the integrity of the sample contents. The first vial 105 and the second vial 110 are manufactured under sterile and transparent conditions. It is particularly important to note that both vials are made of materials that are resistant to the chemicals of the semen sample and / or the stabilizing medium 120, such as polypropylene, polystyrene, polyethylene and borosilicate glass. In some embodiments, the first vial 105 and the second vial 110 are made of materials specifically designed for low to high temperature storage environments. The first vial 105 and the second vial 110 can range in volume from a few milliliters to several tens of milliliters, and can be made to the same size or to different sizes as desired. The vials can also be provided with graduation lines to facilitate the observation of the volume and level of the semen sample within the vials. The dual vial design not only helps to maintain the integrity of the semen sample mixed with the stabilizing medium 120 in the second vial 110, but the first vial 105 can also serve as a backup of the pure human semen. As shown, the second vial 110 contains a predetermined amount of the stabilizing medium 120. The dual vial set 100 is also provided with a transfer device 115 for the convenient transfer of the semen sample from the first vial 105 to the second vial 110. The transfer device 115 can take many forms, such as a spike, a needle or a special connector, depending on the specific application requirements. In some embodiments, the transfer device 115 takes the form of a syringe. Importantly, the transfer device 115 is also manufactured under sterile conditions, and it ensures that the transfer of the semen sample between the vials is controlled and accurate. Similar to the vial design, the transfer device 115 is also provided with graduation lines to assist in the accurate transfer of the semen sample. The transfer device 115 is also made of materials that are resistant to the chemicals of the semen sample, such as polypropylene, polystyrene, polyethylene and borosilicate glass.

[0071] In one embodiment of the disclosure, the dual vial set 100 is accompanied by clear and informative labels on both vials and their packaging. These labels provide key information such as user identification code, substance name, and all necessary warning content. In another embodiment, the dual vial set 100 is equipped with a detailed instruction manual, which is designed to provide medical professionals with guidelines for proper set preparation, sample collection, storage, and transportation. To ensure the safety of the dual vial set 100, a protective shell is provided and placed within a protective outer packaging. The outer packaging can take various forms, such as a box, a blister pack, or other types of containers. The protective outer packaging can be made of various suitable materials that effectively protect the vials and the transfer device 115 from contamination and other external factors, such as physical damage, temperature fluctuations, light exposure, or moisture. Additionally, the protective outer packaging acts as a barrier to contaminants, maintaining an internal sterile environment and preventing the intrusion of dust, microorganisms, or other impurities. This packaging material is durable, resistant to tearing, and resistant to puncture, and can withstand various harsh conditions during transportation. In certain embodiments, the dual vial set 100 is also equipped with temperature regulating elements to ensure that the temperature of the first vial 105 and the second vial 110 is stable before and after the use of the dual vial set 100. These temperature regulating elements come in various forms, including but not limited to ice packs, gel packs, and hot packs. Additionally, there are other types of temperature regulating elements, such as films or laminates, which are attached to the outside of the cardboard box containing the dual vial set 100 to maintain the temperature stability of the stabilizing medium 120. Furthermore, one or more compartments within the protective outer packaging are specifically designed to have a temperature control system to actively regulate the temperature of the first vial 105 and the second vial 110 after the vials are placed inside. For example, when the second vial 110 contains only the stabilizing medium 120, the temperature regulating system maintains the temperature between 2 degrees Celsius (°C) and 12 degrees Celsius (°C). When the second vial 110 contains a uniform mixture of the stabilizing medium 120 and the semen sample, the temperature regulating system controls the temperature to be close to body temperature. To enhance safety and convenience, the dual vial set 100 in certain embodiments also contains alcohol wipes or disinfectant wipes to disinfect the skin or equipment before collecting the sample. At the same time, the set also contains disposable gloves to ensure that the sterile environment is maintained during the collection or processing of the sample and to protect the user. In addition, to monitor the temperature of each vial in real time, the dual vial set 100 is equipped with temperature indicators to display the real-time temperature of each vial in the set.

[0072] Fig. 3An operational flowchart 200 using the dual vial set 100 is shown, which is intended to guide how to collect, package, store and ship a semen sample from a subject. The flowchart starts at step 205, and then in step 210, a pure and impurity-free semen sample is collected in the first vial 105. For example, the semen sample can be derived from a human. In step 215, a portion of the semen sample in the first vial 105 is transferred to the second vial 110 using the transfer device 115, and the second vial 110 has been pre-loaded with a certain amount of stabilizing medium 120. The amount of semen sample transferred is carefully calculated to ensure that the mixing ratio with the stabilizing medium 120 is 1 :3 (i.e., the ratio of semen to stabilizing medium is 1 :3). Such a ratio ensures that the semen sample remains stable and biologically active for the next 72 hours, providing an accurate sample for subsequent analysis. Specifically, in one example, 1 milliliter of semen sample is added to 3 milliliters of stabilizing medium 120.

[0073] In some embodiments of the present technology, the second vial 110 is pre-loaded with a volume of stabilizing medium 120. The stabilizing medium 120 is composed of a variety of components, including but not limited to pH buffers, inorganic salts, organic compounds, and amino acids with antioxidant properties, all dissolved in water. The preparation of the second vial 110 can be performed prior to the collection of the semen sample, or during the collection process. In some embodiments, if the second vial 110 is pre-prepared, it is stored at a temperature of 2°C to 12°C. In some embodiments, the second vial 110 containing the stabilizing medium 120 is stored at the above-mentioned temperature range using ice packs or the like. Alternatively, a microprocessor-controlled cooling device can be used to maintain the temperature of the stabilizing medium 120 in the second vial 110 at a temperature of 2°C to 12°C. It is important to note that the stabilizing medium 120 should be stored at a temperature of 2°C to 12°C using a refrigerator or gel ice packs or the like when it is not in use or mixed with the semen sample, especially when the dual vial kit 100 is to be transported. The stabilizing medium 120 should be brought to room temperature before mixing with the semen sample. The mixed stabilizing medium 120 and semen sample should be maintained at a temperature close to body temperature and should not be cooled after mixing. In some embodiments, the pH buffers that can be used include HEPES (4-(2-hydroxyethyl)-l-piperazineethanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), Tris (tris(hydroxymethyl)aminomethane), MOPS (3-(N-morpholino)propanesulfonic acid), and phosphate buffers. The inorganic salts can be selected from sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2), sodium bicarbonate (NaHCO3), magnesium sulfate (MgSO4), and sodium citrate. The organic compounds can be selected from proteins, sugars, osmotic pressure regulators, chelating agents, lipids, and enzymes. The amino acids with antioxidant properties can be selected from alanine, aspartic acid, asparagine, glutamic acid, alanyl-glutamine, glycine, proline, and serine.

[0074] Next, in step 220, the semen sample is mixed with the stabilizing medium 120 and agitated to obtain a homogeneous solution. The specific conditions of agitation, including duration and intensity, can vary depending on the specific circumstances, but must ensure that the mixture is sufficiently homogeneous.

[0075] Next, in step 225, the homogenized solution in the second vial 110 is stored in a temperature environment close to body temperature. According to one embodiment of the present application, the storage temperature of the second vial 110 is maintained between 36.1 °C and 37.2 °C. In another embodiment, the first vial 105 containing the remaining human semen is also stored as a back-up. In certain embodiments, the dual vial kit 100 contains one or more of the following materials for maintaining the temperature of the homogenized solution in the second vial 110: foam inserts or inclusions, phase change materials, microprocessor controlled heating devices, insulating packaging or film or laminate, and gel packs.

[0076] Finally, in step 230, the dual vial kit 100 is sent out for storage or analysis. The homogenized solution stored in the second vial 110 is available for analysis of the semen sample within 72 hours after the initial mixing with the stabilization medium 120, thereby effectively extending the time period for which the semen viability is maintained. The flowchart 200 ends at step 235.

[0077] The dual vial kit 100 and its method of use has significant advantages in home male fertility diagnosis. By employing a 3: 1 dilution ratio of semen to stabilization medium 120, and leaving undiluted semen in the first vial 105 as a control sample, the present application not only ensures the integrity of the sample, but also broadens the scope of diagnostic analysis. Furthermore, the present application addresses the problem of semen volume variation, thereby improving the accuracy of analysis. More importantly, the method of use of the present application effectively maintains the quality of human semen samples for up to 72 hours.

[0078] It should be understood that although we have described and illustrated certain specific forms of the application, it is not to be limited to the specific forms or arrangement of parts herein described and illustrated. The scope of the application is fully defined by the appended claims. Certain features of the application, which are of novelty, are described in the specification and are particularly pointed out in the claims. The foregoing and other features of the application are hereinafter more fully described and illustrated in the accompanying drawings and in the following detailed description. Several features can be independently used or combined in various combinations and can be used in conjunction with other features described herein or known in the art. A single feature can address one or more of the problems described above. Some of the problems discussed above can not be fully addressed by any single feature described herein.

[0079] List of Reference Signs

[0080] 10 - System device

[0081] 100 - Dual vial kit

[0082] 105 - First vial container

[0083] 110 - Second vial container

[0084] 115 - Transport means

[0085] 120 - stabilizing medium

Claims

1. A method for collecting and preserving a semen sample of an individual for extending its survival time using a dual vial kit (100), characterized in that comprising the steps of: collecting a raw semen sample from an individual in a first container (105); transferring a predetermined amount of the semen sample from the first container (105) into a second container (110) and mixing it with a stabilizing medium (120) therein to produce a homogeneous solution; and storing the homogeneous solution for a predetermined period of time in the stabilizing medium (120) for performing semen analysis while maintaining the viability of the semen sample for a predetermined length of time.

2. The method of claim 1, wherein, transferring a predetermined amount of the semen sample from the first container (105) into a second container (110) further comprises stirring the mixture of the semen sample and the stabilizing medium (120) until a homogeneous solution is produced.

3. The method of any preceding claim, wherein, transferring a predetermined amount of the semen sample from the first container (105) into a second container (110) further comprises mixing the semen sample with the stabilizing medium (120) at a dilution ratio of 3:1 to produce a mixture, wherein the mixture comprises 3 parts of the stabilizing medium (120) and 1 part of the semen sample.

4. The method of any preceding claim, wherein, further comprising storing the homogeneous solution in the second container (110) at a temperature of approximately body temperature.

5. The method according to any one of claims 1 to 3, characterized in that, further comprising storing the homogeneous solution in the second container (110) at a temperature of between 36.1 degrees Celsius (°C) and 37.2 °C.

6. The method of any preceding claim, wherein, further comprising storing the stabilizing medium (120) at a temperature of between 2 degrees Celsius (°C) and 12 °C prior to mixing with the semen sample.

7. The method according to any one of the preceding claims, wherein the method further requires storing the stabilizing medium (120) at a temperature range of between 2 degrees Celsius (°C) and 12 °C prior to mixing with the semen sample.

8. The method according to any one of the preceding claims, wherein the stabilizing medium (120) comprises one or more components including, but not limited to, one or more pH buffers, one or more inorganic salts, one or more organic compounds, and one or more amino acids with antioxidant properties, and wherein all of the components of the stabilizing medium are soluble in water.

9. The method according to any one of the preceding claims, wherein the method further requires leaving a remaining semen sample in the first vial (105) as a back-up for transportation together with the second vial (110) containing the homogeneous solution.

10. The method according to any one of the preceding claims, wherein the predetermined portion of the semen sample in the first vial (105) is transferred into the second vial (110) using a transfer device (115), wherein the transfer device is a syringe.

11. The method according to any one of the preceding claims, wherein the predefined time is set to 72 hours.

12. A system (10) intended to collect and preserve a semen sample of a subject, in order to prolong its survival time, the system (10) being characterized in that it comprises: A dual vial kit (100) comprising a first vial (105) for collecting a semen sample from a subject; a second vial (110) containing a predetermined volume of a stabilizing medium (120); and a transfer device (115) for transferring a predetermined portion of the semen sample from the first vial (105) to the second vial (110), the transfer device (115) being designed to ensure that a portion of the semen sample is transferred to the second vial (110) containing three times the volume of the stabilizing medium (120) to achieve dilution.

13. The present invention provides a dual vial kit (100) specifically designed for collecting, packaging, storing and transporting a semen sample from a subject. It is unique in that it comprises the following components: a first vial (105) for collecting a semen sample from a subject; a second vial (110) containing a predetermined volume of a stabilizing medium (120); and a transfer device (115) for transferring a predetermined portion of the semen sample from the first vial (105) to the second vial (110). The transfer device (115) is designed to ensure that a portion of the semen sample is transferred to the second vial (110) containing three times the volume of the stabilizing medium (120) to achieve dilution.

14. The dual vial kit (100) according to claim 12, wherein the first vial (105) and the second vial (110) are both sealable to ensure airtightness and leakproofness to maintain the integrity of the sample.

15. The dual vial kit (100) according to any one of claims 12 to 13, further comprising labels provided for the first vial (105) and the second vial (110) to facilitate identification and management.

16. The dual vial kit (100) according to any one of claims 12 to 14, further comprising a protective outer packaging designed to hold the first vial (105), the second vial (110) and the transfer device (115), wherein the transfer device is in the form of a syringe.

17. The dual vial kit (100) according to any one of claims 12 to 15, further comprising detailed instructions for guiding the user on how to collect, package, store and transport a semen sample from a subject.

18. The dual vial kit (100) according to any one of claims 12 to 16, wherein the stabilizing medium (120) is composed of a plurality of components including, but not limited to, one or more pH buffers, inorganic salts, organic compounds, and amino acids with antioxidant properties. All these components are dissolved in water to ensure the effectiveness of the stabilizing medium.

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