Claims:We Claim:

1. A saliva collection kit comprising:
a collection tube to collect a sample of saliva from a patient who is potentially infected with a virus;
a saliva collection funnel that is inserted into the collection tube to receive the sample from the patient; and
a molecular transport medium positioned that is at bottom of the collection tube, wherein the molecular transport medium lyses and inactivates the virus present in the sample of the saliva at site of sample collection and reduces the risk of infection to others during sample transport and analysis.
2. The saliva collection kit as claimed in claim 1, has a unique composition of the molecular transport medium that enables the sample to be transported at room temperature and to directly detect the virus by reverse transcription–polymerase chain reaction (RT-PCR), without ribonucleic acid (RNA) extraction, wherein the molecular transport medium comprises protein denaturants and amphiphilic detergents, which causes the lysis of the virus, and enables release of nucleic acids into the molecular transport medium, after the sample collection.

3. The saliva collection kit as claimed in claim 2, further comprises a mixture of chaotropic agents that stabilize and protect lysed RNA polymers of the sample from hydrolysis, oxidative damage or nuclease degradation for prolonged periods at ambient temperature, until the lysed RNA polymers are processed using nucleic acid amplification techniques, which enables the sample to be transported at room temperature after the sample collection.

4. The saliva collection kit as claimed in claim 2, further comprises reducing agents that reduce disulfide bonds of RNAases in the sample, which increases RNA yield and thereby enhancing sensitivity of nucleic acid amplification techniques.

5. The saliva collection kit as claimed in claim 1, wherein after capping the saliva collection funnel on to the collection tube, an opening of the collection tube is sealed except for container escape vents, and wherein during a horizontal fall of the saliva collection kit, the container escape vents are the only locations through which the sample inside the collection tube leaks through.

6. The saliva collection kit as claimed in claim 5, further comprises a liquid locking rib positioned adjacent to the container escape vent, wherein the liquid locking rib forms a tight seal on the outer surface of the collection tube when capped, and wherein liquid and air escaping from the collection tube through the container escape vent is blocked by the liquid locking rib.

7. The saliva collection kit as claimed in claim 6, further comprising an air escape vent that is located perpendicular to the container escape vent, wherein placement of the air escape vent makes the air escape vent accessible only by particles that have a sufficient pressure to push and overcome the liquid locking rib.

8. The saliva collection kit as claimed in claim 7, wherein liquid particles present in the collection tube are at a neutral pressure during one of the sample collection and during an accidental fall, and the molecular transport medium cannot overcome the liquid locking ribs to access the air escape vent, wherein air particles inside the collection tube are pressurized while spitting the saliva into the collection tube and pushing pressure from the saliva makes the air particles inside the collection tube to overcome the liquid locking rib and to access the air escape vent to escape out of the saliva sample collection kit, which avoids air locks inside the collection tube that prevents the flow of saliva.

9. The saliva collection kit as claimed in claim 8, wherein if the collection tube falls upside down and land in an inverted manner, a liquid catchment chamber is present in the saliva collection funnel that forms a secondary storage zone for the molecular transport medium in the collection tube, wherein the molecular transport medium falls directly into the liquid catchment chamber, and wherein the molecular transport medium is prevented from accessing the container escape vent to prevent leakage of the molecular transport medium.

10. The saliva collection kit as claimed in claim 9, wherein when the collection tube gets inverted upside down the molecular transport medium and saliva inside the collection tube flows to the liquid catchment chamber, and wherein the liquid catchment chamber is designed to hold maximum volume of 3 ml.

11. The saliva collection kit as claimed in claim 9, further comprising a mouth contoured profile of the saliva collection funnel that includes:
a lip resting zone that is configured to snug fit bottom lip of the patient that guides and enables the patient to rest bottom half of mouth of the lip resting zone during the complete saliva collection process; and
a splatter shield zone that is in communication with the lip resting zone, wherein as the lip resting zone guides the patient to rest their mouth, the splatter shield zone covers remaining area of the patient’s mouth completing the seamless fit between patient’s mouth and the saliva collection funnel, wherein combination of the lip resting zone and the splatter shield zone reduces infection spread rate due to the virus by preventing splattering of the saliva into the surrounding environment.
Dated this 26th day of October 2021

Bency Varghese
Patent Agent for the applicant (INPA/2313)
, Description:FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(Section 10 and rule13)

SALIVA BASED TESTING KIT FOR CORONA VIRUS WITH MOLECULAR TRANSPORT MEDIA AND FUNNEL

KRIYA MEDICAL TECHNOLOGIES PVT LTD Indian Y-Block, 5/2731, 12th Main Road, 7th Street, Anna Nagar, Chennai - 600 040, India

The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF INVENTION
[0001] The present invention relates to a saliva-based testing kit for corona virus with a molecular transport media is specifically intended for safe, fast, and easy self-collection of saliva sample for a quick and extraction free testing of SARS-COV2 (RT-PCR).

BACKGROUND OF THE INVENTION:
[0002] In the current times, most part of the world are facing the problem of issues related to SARS-COV2 or infamously known as Covid-19. Covid-19 has resulted in deaths of millions across the globe as well as degrading the health of many individuals post covid issues. Therefore, a timely testing and determining of the infection is crucial in order to provide early care for the patient as well as to prevent the widespread of the sickness. There are many testing methods that include collection of saliva and also nasal swab. However, the collection methods currently practised have some drawbacks.

[0003] The saliva collection devices of the prior art have two major drawbacks. Considering the first drawback, the generic saliva collection device has two components, a container to store sample and a funnel that connects with the container to collect and transfer the sample into the container. During the saliva collection process, the saliva spitted into the funnel starts to flow into the container. But the flow of saliva sample can be achieved only when the air inside the container can flow out of the container. If the container and funnel assembly is airtight then the air inside the container will chock the flow of saliva and creates a blockage. The saliva collection devices of the prior art avoid this chocking problem by completely avoiding any kind of leak proof features in the design. But this in turn causes the saliva collection device susceptible to leakage of saliva and chemical media inside the container. During any accidental fall the absence of a leak proof mechanism exposes the patient to chemical media, causes contamination of sample and may lead to spreading of infected samples.

[0004] Considering the second drawback, the saliva collection process usually takes 2 to 3 minutes of continuous spitting to collect optimal volume of saliva. And saliva collection is done in the privacy of the patient, without any monitoring. So, the saliva collection funnel and the collection device must be designed ergonomically to ensure and encourage the patient to provide proper saliva sample. But no saliva collection funnels, and devices of the prior art have addressed this problem.

[0005] Most of the existing viral transport media uses a swab sample. Swab sample collection involves a health care worker and hence utilises manpower and increases the risk of viral exposure to health care workers. The existing saliva collection funnel designs ignore any type of leak prevention mechanism. Because it causes air locks and prevent the flow of saliva into the container. But the absence of a leak proof mechanism puts the end user directly exposed to the chemical media inside the container during any accidental drops and falls. The saliva spitting operation usually takes more than 2 minutes to complete. The existing funnel designs lack any feature that encourages this prolonged spitting operation.

[0006] Since the saliva collection is mostly done in person without any monitoring, the spitting funnel design itself must promote the proper collection of saliva and the patient safety. But the existing funnels do not have features relating to this field. Existing viral transport media use swab as a sample, which involves health care workers and hence additional manpower requirement and potential spread of infection to health care workers during sample collection. Existing media also do not inactivate virus and hence there is a possibility of the spread of infection during sample transport and sample processing. Existing media do not have nucleic acid stabilising agents and hence the media after sample collection have to be transported at 2 to 80C and a possible reduction in sensitivity of detection techniques. Molecular diagnosis of SARS CoV2 using the existing viral transport media involves a nucleic acid extraction step followed by a RT-PCR amplification and detection step. This increases the turnaround time and the cost per test.

[0007] Therefore, there is a need for saliva-based testing kit for corona virus that addresses and resolves the above-mentioned issues in COVID testing. The saliva-based testing kit is expected to include a transport media that is specifically intended for safe, fast, and easy self-collection of saliva sample for a quick and cost-effective extraction free testing of SARS-COV2 RT-PCR.

SUMMARY OF THE INVENTION:
[0008] This summary is provided to introduce a selection of concepts in a simplified form that are further disclosed in the detailed description of the invention. This summary is not intended to identify key or essential inventive concepts of the claimed subject matter, nor is it intended for determining the scope of the claimed subject matter.

[0009] The saliva collection kit of the present disclosure comprises two main components, such as the saliva collection funnel and a collection tube with molecular transport media. The saliva collection funnel provides an optimal sample collection environment and ensures the patient safety by keeping the molecular transport media leak free during any accidental drops and falls. The unique composition of the medium inactivates the virus at the sample collection site and hence reduces the infection risk and makes the sample safe to handle during sample transportation, storage and analysis. The medium supports direct RT-PCR amplification without RNA extraction step and this considerably reduces the turnaround time and makes the diagnosis process quick.

[0010] The proposed molecular transport media uses a saliva sample. Saliva sample is self-collected and does not involve a health care worker. Hence, utilises less manpower and reduces the risk of viral exposure to health care workers. The top profile of the saliva collection funnel is designed with a unique pattern that is ergonomic to the human mouth. So, the saliva spitting action (which usually takes more than 2 minutes) is performed with the patient’s comfort. The locking mechanism of this saliva collection funnel is engineered with novel features that avoid any leakage of molecular transport media and saliva. At the same time, it avoids creating any air locks for the easy flow of saliva into the tube during spitting action.

[0011] The saliva collection funnel is designed with the feature that allows the air to escape from the enclosed tube but at the same time restricts the flow of any liquid substance. This molecular transport medium lyses and inactivates the virus at the site of sample collection and hence nullifies the risk of infection spread during sample transport, storage and analysis. This molecular transport medium includes nucleic acid stabilising agents and hence the media can be transported at room temperature even after sample collection. The molecular diagnosis of SARS CoV2 using this molecular transport media can skip the nucleic acid extraction step and RT-PCR amplification and detection step can be performed directly. This reduces the turnaround time and the cost per test.

BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The foregoing summary, as well as the following detailed description of the invention, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, exemplary constructions of the invention are shown in the drawings. However, the invention is not limited to the specific methods and components disclosed herein. The description of a method step or a component referenced by a numeral in a drawing is applicable to the description of that method step or component shown by that same numeral in any subsequent drawing herein.

[0013] Figures 1A and 1B show sectional internal view and front view respectively, of the saliva collection kit that is designed with features that facilitate the saliva collection kit to be more ergonomic to human use and improves the safety factor of the same device by preventing any accidental leakage.

[0014] Figures 2A-2B show a leak proof design of saliva collection kit that allows air to pass but blocks the flow of liquid, as an embodiment of the present invention.

[0015] Figure 3 shows a first accidental scenario during when the collection tube is tilting towards mouth.

[0016] Figure 4 shows a second accidental scenario where complete inversion of collection tube occurs.

[0017] Figures 5A and 5B show a third accidental scenario that describes a horizontal fall of the collection tube.

[0018] Figures 6A and 6B show a front perspective and top perspective view respectively, of the saliva collection funnel of the saliva collection kit with the ergonomic mouth contour.

DETAILED DESCRIPTION OF THE DRAWINGS
[0019] Exemplary embodiments now will be described. The disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art. The terminology used in the detailed description of the particular exemplary embodiments illustrated in the accompanying drawings is not intended to be limiting. In the drawings, like numbers refer to like elements.

[0020] Figures 1A and 1B show sectional internal view and front view respectively, of the saliva collection kit (10) that is designed with features that facilitate the saliva collection kit to be more ergonomic to human use and improves the safety factor of the same device by preventing any accidental leakage. The saliva collection kit (10) comprises a molecular transport medium (1), a collection tube (2) or container to collect saliva from a patient who is suspected to be infected with a virus, and a saliva collection funnel (3) inserted into the collection tube (2) to receive the saliva from the mouth of the patient. The molecular transport medium (1) is positioned at bottom of the collection tube (2) and is formulated to use saliva sample for molecular diagnosis of SARS CoV2. The present saliva collection funnel (3) is designed to make the saliva collection process safe and comfortable as possible. The saliva collection in general takes place without any monitoring from a healthcare professional. Since the patients are left alone to collect the sample the saliva collection kit (10) focuses on making the saliva collection process optimal and safe for the patient. The molecular transport medium (1) lyses and inactivates the virus at the site of sample collection and hence reduces the risk of infection during sample transport and analysis. The composition of the molecular transport medium (1) enables the sample to be transported at room temperature and to directly detect the virus by RT PCR, skipping RNA extraction. This significantly reduces the turnaround time and the cost per test. The present inventions leak proof mechanism is designed specifically for the standard volume of saliva transport medium and saliva combination (3ml in total). So, the leak proof feature of this design is limited only to a predetermined volume.
[0021] The molecular transport medium (1) has the following components:
Protein denaturant: the molecular transport medium (1) contains a suitable and optimal concentration of protein denaturants and amphiphilic detergents, which causes lysis of the virus, enabling the release of nucleic acids into the molecular transport medium (1), soon after sample collection. This enables direct RT-PCR amplification without RNA extraction step. This considerably reduces the turnaround time and makes the process quick. The viral lysis caused by the protein denaturant, reduces the infection risk and makes the sample safe to handle during sample transportation, storage and analysis. The protein denaturant also inactivates RNAases and hence the released RNA is stabilized. This increases the sensitivity of the amplification detection technique.
[0022] Chaotropic agents: the molecular transport medium (1) contains a mixture of chaotropic agents which stabilize and protect lysed ‘naked’ RNA polymers of the sample from hydrolysis, oxidative damage or nuclease degradation for prolonged periods at ambient temperature, until they can be processed using nucleic acid amplification techniques. Hence, the media can be transported at room temperature even after sample collection
[0023] Reducing agents: the medium contains a reducing agent which reduces disulfide bonds of RNAases in the sample. This increases the RNA yield and hence the sensitivity of nucleic acid amplification techniques is enhanced.
[0024] Referring to the saliva collection funnel (3), the top profile of the saliva collection funnel (3) is designed to enhance the spitting action by giving an ideal surface on which the human mouth ergonomically rests on and complete the spitting action. The locking features in the saliva collection funnel (3) seals the collection tube (2) leak proof to any liquid but at the same time allow the air inside the collection tube (2) to pass by. This ensures the proper flow and collection of saliva in the collection tube (2).
[0025] Figures 2A-2B show a leak proof design of saliva collection kit (10) that allows air to pass but blocks the flow of liquid is achieved by combining four features mentioned below, as an embodiment of the present invention. The saliva collection funnel (3) as shown here solves the above-mentioned leakage problem by providing a leak proof design that allows the air inside the collection tube (2) to pass through but blocks flow of liquid. After capping the saliva collection funnel (3) on to the collection tube (2), an opening of the collection tube (2) is sealed except for two locations called container escape vents (5). Hence, during a horizontal fall of the saliva collection kit (10), the two container escape vents (5) are the only locations through which the contents inside the collection tube (2) leaks through. This container escape vent (5) is accessed by both the liquid and air, that is inside the collection tube (2). But to restrict the liquid flow further and at the same time allowing air to pass out of the saliva collection kit (10). There is another feature next to the container escape vent (5) referred to as liquid locking rib (6).
[0026] The liquid locking rib (6) makes a tight seal on the outer surface of the collection tube (2) when capped. So, the liquid and air escaping from the collection tube (2) through the container escape vent (5) is blocked by the liquid locking rib (6). However, to allow the air to escape the liquid locking rib (6), the liquid locking rib (6) has another vent called air escape vent (7). The air escape vent (7) is located perpendicular to the container escape vent (7), wherein this unique placement of the air escape vent (7) makes it accessible only by the particles that have a sufficient pressure pushing them to overcome the liquid locking rib (6). The liquid particles inside the collection tube (2) are in neutral pressure during the sample collection or even during an accidental fall. So, they cannot overcome the liquid locking ribs (6) to access the air escape vent (7). But the air particles inside the collection tube (2) are pressurized when spitting the saliva into the collection tube (2) so the pushing pressure from the entering saliva makes the air particles inside the collection tube (2) to overcome the liquid locking rib (6) and to access the air escape vent (7) to escape out of the saliva sample collection kit (10) and ultimately avoiding any air locks inside the collection tube (2) that prevents the flow of saliva. But at the same time any kind of horizontal fall and tilts of the sample collection device will not cause the media to leak out.
[0027] The above-described design can prevent leakage during the horizontal fall and tilt of the collection tube (2) but during an accidental fall the collection tube (2) may fall upside down and land in the inverted manner. So, to maintain the leak proof ability of the saliva collection device (10) during an inverted fall scenario a liquid catchment chamber (4) is designed. The liquid catchment chamber (4) present inside the saliva collection funnel (3) acts as a secondary storage zone for liquid particles in the collection tube (2) when its inverted upside down. So, when the saliva collection kit (10) is inverted the media inside the collection tube (2) fall directly into a liquid catchment chamber. Hence, the liquid media is kept completely away from accessing the container escape vent (5) and in turn avoiding leakage of media (3).

[0028] Figure 3 shows a first accidental scenario during when the collection tube is tilting towards mouth. Sometimes patients engage in the saliva collection process without any monitoring from a healthcare person for multiple times. As a result, the way patients holds and spits saliva vary throughout the process, due to the prolonged spitting time. Tilting the present saliva collection kit (10) with media towards the mouth makes the media slide into the liquid catchment chamber that has been extended in inner side of the saliva collection funnel (3). This liquid catchment chamber (4) acts as a secondary storage for media and saliva. During a tilt, as a result the media are always kept away from getting in contact with the patient.
[0029] Figure 4 shows a second accidental scenario where complete inversion of collection tube (2) occurs. When the collection tube (2) gets inverted upside down the media and saliva inside the collection tube (2) flows to the liquid catchment chamber (4) inside the saliva collection funnel (3). The liquid catchment chamber (4) is designed to hold max volume of 3ml, since the media is kept away from the collection tube (2) escape vent the saliva collection kit (10) remains leak proof.
[0030] Figures 5A and 5B show a third accidental scenario that describes a horizontal fall of the collection tube (2). During horizontal fall/tilt of the collection tube (2) the media gets access to the container escape vent (5), but further flow of media gets blocked by the liquid locking rib (6). Since the media do have neutral pressure, it does not have sufficient push to overcome the liquid locking rib (6) and to reach the air escape vent (7). So, it stays trapped within the collection tube (2), making it leak proof.
[0031] Figures 6A and 6B show a front perspective and top perspective view respectively, of the saliva collection funnel of the saliva collection kit with the ergonomic mouth contour. The saliva collection funnel (3) in the present disclosure is designed with human mouth contoured profile (8). While spitting into the present saliva collection funnel (3), the mouth contoured profile (8) fits seamless to patient’s mouth. This seamless fit between patients mouths and saliva collection funnel (3) ensures that the spitted saliva particles are not splattered into the environment as there is no gap for them to escape into the environment.
[0032] The mouth contoured profile (8) of the present saliva collection funnel (3) is divided into two sections, a lip resting zone (9) and a splatter shield zone (11). The lip resting zone (9) of the saliva collection funnel (3) is specifically designed to snug fit bottom lip of the patient which guides and enables patients to rest the bottom half of their mouth of the lip resting zone (9) during the complete saliva collection process. As the lip resting zone (9) guides the patient to rest their mouth the splatter shield zone (11) follows up and covers the remaining area of the patient’s mouth completing the seamless fit between mouth and the saliva collection funnel (3). The combination of the lip resting zone (9) and splatter shield zone (11) improves the ergonomics of the saliva collection funnel (3) which results in better saliva sample collection and reduces the infection spread rate by preventing splattering of saliva into the surrounding environment.
[0033] With the usage of the saliva collection kit (10) as described in the present disclosure, the risk of health care worker getting infected during swab sample collection is avoided, as the saliva collection kit (10) uses saliva sample, which can be collected by the individual himself or herself. The risk of exposing the patients to the chemical medium within the collection tube (2) during any accidental drops is overcome in the usage of the saliva collection kit (10). The absence of any leak prevention features in the existing funnels due to air locking constrains are overcame by the saliva collection funnel (3) of the saliva collection kit (10) by adding a feature that avoids both liquid leakage and formation of air lock. The existing funnels focus only on providing a large opening to spit saliva but they lack any ergonomic features. Since the average spitting action takes couple of minutes a non-ergonomic funnel causes discomfort to patients. This drawback is overcome by the top profile of the saliva collection kit (10).
[0034] There is a risk of health care workers getting infected during sample transport and analysis in the existing viral transport media. This is overcome by the present molecular transport medium (1), which inactivates the virus at the site of sample collection. The existing molecular transport media (1) must be transported in a cold chain (2-to-8-degree Celsius). The present Molecular transport medium can be transported at room temperature. Molecular diagnosis of SARS CoV2 from a sample collected in the existing viral transport medium involves two steps: RNA extraction and RT PCR detection. Hence the turnaround time is longer and the cost per test is high. The molecular transport medium (1) allows the extraction step to be skipped and direct detection by RT PCR is possible. This reduces the turnaround time and the cost per test.
[0035] The saliva collection kit (10) is used for the safe collection and transportation of saliva sample for a quick, sensitive, and economical molecular diagnosis of SARS CoV2 infection. As the saliva collection is done without any guidance, the saliva collection kit (10) ensures error free and safe collection and transport of specimens containing viruses. The saliva collection kit (10) is used for screening health care workers and students on regular basis for SARS CoV2 infection, as saliva sample collection is hassle free and can be repeated at regular intervals. The saliva collection kit (10) contains a medium, which increases the sensitivity of the SARS CoV2 molecular detection techniques.
[0036] While the present disclosure has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departure from the scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present disclosure without departure from its scope. Therefore, it is intended that the present disclosure not be limited to the particular embodiment disclosed, but that the present disclosure will include all embodiments that fall within the scope of the appended claims.