Self-Assessment of HPV Smear and Results Kit Package

Abstract

This invention is a test kit developed to detect the HPV virus. This kit allows women to self-detect the HPV virus. The test is designed for easy use, anytime and anywhere, offering advantages for women who have difficulty accessing healthcare or who value privacy. The test takes a cellular sample from the vaginal opening, distinguishing between the urethra and the vagina. Users can quickly determine if they carry HPV 16 and 18 using the test strip. Alternatively, samples can be sent to screening centers for those who prefer not to see the results. Finally, test results can be shared and tracked on digital platforms like e-nabız (the Turkish national health information system) via QR code. This invention aims to contribute to the early detection and treatment of cervical cancer.

Description

1 TARIFF Self-Assessment of HPV Smear and Results Kit Package Subject of the Invention and Technical Field 5 This invention was developed to detect cervical cancer and is sensitive to self-touching. easily used by women who are shy, lack information, and do not know their bodies. It can be used. Individuals can easily collect samples alone or with the help of someone, and the results can be obtained. You can quickly view the results of a self-test for HPV and obtain a result sheet. le lg ld r. 10 State of the Technology Cervical cancer is a cancer that begins in the cells of the cervix and spreads over time. This type of cancer is generally caused by a virus called Human Papillomavirus (HPV). It is related to infection. HPV infection is transmitted sexually, and some types affect the cervix. It can lead to abnormal changes in cells. These abnormal cells can become cancerous and 15 It can cause cancer over time. Cervical cancer usually does not show symptoms in the early stages, but as it progresses, vaginal bleeding may occur. Symptoms such as pain during intercourse and pelvic pain may occur. With early diagnosis and treatment, the uterus... Oral cancer can be cured. Therefore, regular Pap smear tests and HPV screenings are important. Because cervical cancer is a major health problem among women worldwide, and 20 Regular screenings, vaccinations, and early detection methods can prevent or treat these conditions. The HPV smear test is a routine procedure generally performed for cervical cancer screening and These services are generally covered by health insurance. HPV smear tests are generally provided by a healthcare provider. This is a medical test performed by a specialist. The most common places where this test is administered are: gynecologists. examinations, medical services, women's health centers, hospitals, clinics and university health 25 It is implemented in centers. An HPV smear test is generally performed by healthcare professionals. A healthcare professional First, a speculum is inserted into the vagina and used to examine the cervix. This During the examination, the cervix and cervical cells are visually inspected. Then, A healthcare professional uses a brush or spatula to collect a cell sample from the cervix. This 30 For example, taking cells from the surface of the cervix can indicate an HPV infection, or The sample is prepared in a way that allows for the identification of precancerous changes. The sample is then sent to the laboratory. 2 The samples sent here contain specific genetic material for HPV infection or cervical cancer. Other tests are performed that may show abnormal changes in the cells. HPV smear tests are recommended, especially for women aged 30 and over, and should be done regularly. When performed, it is an effective tool used in the prevention of cervical cancer. Recommended test. The frequency can vary depending on the person's age, health history, and risk of HPV infection. 5 In the current technological landscape, significant progress has been made in cancer screening and early diagnosis methods. It has been recorded. One of them is cancer treatment that people can apply to themselves. The increase in testing is due to these tests, which allow individuals to regularly check their health status. And it can help them detect early-stage cancers. The document encountered in the case of Tekn ğ nbl nen is Korean patent number KR20180098471A. 10 The document in question is about a brush used to collect cervical cells. Cervical The brush, designed to collect cells, has a brush body, and a tip at the end of the brush body. area with at least k collecting elements and at least k protrusions located on the side surface of the brush body cher r. The document encountered in the case of Tekn ğ nbl nen is Chinese patent number CN116411075A. (Söz 15) The document in question mentions, for example, a nucleic acid molecule used to detect cervical cancer. This invention demonstrates the application of the brkt and nucleic acid molecule. The provided kit can be applied to the screening, detection, and diagnosis of cervical cancer. The kit is a whole genome-based method. The method was developed based on the dz leme method, examples include cervical scraping and blood gbbr. For example, 20 The document encountered in this technical case is Chinese patent number CN109439750A. The subject of the document is a molecular marker for determining the susceptibility of cervical cancer. It reveals the method and application. The susceptibility of cervical cancer is determined and thus Molecular markers are used in screening high-risk groups for cervical cancer and identifying susceptible individuals. In the detection of cervical cancer, a complex disease, early prevention, early diagnosis and 25 Individualized prevention and treatment have significant practical implications. The document encountered in the technical issue is Turkish patent number TR2021 / 013977. The document in question discusses different types of cancer, particularly cervical cancer and precancerous lesions. The invention relates to diagnostic tests or rapid detection of lesions. Specifically, the invention concerns the aforementioned... Specific and beneficial protein biomarkers for the detection of diseases and the aforementioned 30 This relates to methods for determining and identifying bioreactive filters. 3 Accordingly, in the current situation, cervical ... Many tests are available for use in cancer detection. However, these tests are generally medical in nature. This is done by a qualified or healthcare professional. This ensures accessibility and ease of use. This can lead to certain limitations in these areas. In this context, someone who doesn't know their body, doesn't know themselves... 5 Can be easily used by women who are hesitant to touch or lack knowledge. A QR code is a structure that can determine the opening in the body where it should be applied. Self-testing and results package integrated into DJ and Tal healthcare platforms. It needs to be developed further. Technological Problems That the Invention Aims to Solve 10 The invention concerns self-testing of HPV and the use of a result packet. In this case, gynecological examinations, medical clinics, women's health centers, hospitals, Unlike traditional HPV tests performed in clinics and university health centers. In this way, people can easily collect sample 15 on their own or with the help of an assistant. They aim to develop a method to determine vaginal opening. Using a lightweight, elastic sleeve with litmus-like properties, it helps women who have difficulty recognizing their bodies to identify which body shape they prefer. This allows them to easily identify what samples can be taken from the opening. The biggest advantage of the invention, which involves self-testing for HPV and obtaining the results in a package, is that it protects the uterus. The goal is to ensure early detection of the HPV virus, which causes oral cancer. This is 20 By eliminating the need for another person to test, the individual can test independently. This enables people to do it. This prevents delaying health checkups and provides the advantage of early diagnosis. The HPV virus causes abnormal changes in the cells of the cervix, leading to cancer. This could be the reason. HPV-16 and HPV-18 are responsible for two-thirds of cervical cancers, therefore... The test contains HPV-16 and HPV-18 antibodies. This test is administered to women on test 25. to eliminate their dependence on others for their applications, on their own, This allows them to detect the HPV virus in any location and at any time. Thus, healthcare... services are also accessible to disadvantaged groups who have barriers to access or who value their privacy. It makes it easier for many women, including those with disabilities, to access cancer screening. The subject of the invention is self-testing for HPV and result processing, and the advantage is; 30 in the form of a brochure that women can use to detect the presence of the HPV virus by taking a sample from themselves It is designed to be used with a toilet, sink, or standing, with the help of a relative or on one's own. They can be applied to them in simple steps. 4 The invention concerns self-testing for HPV and the advantage of the results package; vaginal... Vaginal opening is a crucial step in HPV virus detection testing. Vaginal opening is the area outside the vagina of a woman. The reproductive organs include the urethra (the exit point of the urinary tract), located between the vagina and the anus. These are openings. However, many women may not know where these openings are. HPV virus detection. A method is used to accurately determine the vaginal opening during the test. This 5 The method is performed using an elastic sheath with litmus properties placed on the test strip. Litmus The elastic sheath, in particular, distinguishes the vagina from the urethra. The urethra is the exit point of the urinary tract. Because of this, the elastic sheath senses the acidic environment of the urethra. and the color changes. During the test, if the elastic sheath changes color, this indicates a problem with the urethra. It originates from the environment and means that the vaginal opening is not there. Therefore, test n 10 This ensures that the procedure is applied correctly and the right point for sample collection is determined. Side test, First, the vaginal opening is determined, then a sample is taken, and finally the sample is analyzed. It consists of testing phases. The subject of the invention is a self-testing HPV smear and results data package; its other purpose is the test result. If the result is positive, it means the woman is at high risk for cervical cancer and needs further medical attention. The aim is to enable those taking the test to understand whether evaluation and treatment may be needed. With this rapid test strip, you can also find out whether you carry the HPV-16 and HPV-18 viruses. They can learn. This, in turn, provides more specific information, allowing patients to better understand their health conditions. It enables them to understand. The subject of the invention is a self-testing and results processing kit package; its other purpose is to provide test results for 20 years. The e-health system is integrated into digital platforms using QR codes. This allows patients to view their results. They should share the results with the physicians and follow up on the sample collection results for further examination if necessary. These processes are made easier. This also makes it easier to manage the treatment process and access healthcare services. It aims to improve. 30 Explanation of the Figures Figure 1: The subject of the invention is a self-testing HPV smear and the results included in the package. The image shows the internal mechanism of the injector. Figure 2: The subject of the invention is a self-testing HPV smear and the results included in the package. The image shows a detailed picture of the tip of the syringe. 5 Figure 3: The subject of the invention is a self-testing HPV smear and the result package contains the following information: The image shows the drip tip and drip tip stopper. Figure 4: The subject of the invention is a self-testing HPV smear and the results included in the package. It shows the external appearance of the injector and a picture of the push button in its active state. Figure 5: The subject of the invention is a self-testing HPV smear and results kit containing 10 samples. The image shows the external appearance of the injector and a picture of the push button in its original state. Figure 6: Subject of the invention: Self-testing for HPV smear and rapid test included in the results kit package. It shows the picture of the bar. 6 Part and component reference numbers that will help in disclosing the invention. 1- Push-button movement key 2-V branch ml 3-Left-right movable bearing 5 4-Red marker line 5-P stone release spring 6-Turning and tightening nut 7- Liquid transfer stone 8-Elast felt 10 9-Drip nozzle 10-Drip nozzle stopper 11-Sample collection section 12-Liquid reservoir 13-Sample container with liquid and brush 15 14-Control line 15-HPV-16 gene anti-protective line 16-HPV-18 gene anti-protection line 17-Sample group section 18-QR reading section 20 19-Litmus-resistant elastic case 20-Sample collector brush 21- Injector 22-Test strip 7 Detailed Description of the Invention The invention concerns self-testing for HPV and accessing results through a package of healthcare services. It is specifically designed for people who have restrictions or who value privacy. This book, It can be used independently or with assistance, without consulting a doctor or specialist. This is especially true for... It is beneficial for disabled, elderly, or women who are not familiar with their own bodies. 5 The subject of the invention is self-testing for HPV and the resulting package, in the female reproductive organs. cancer that has the ability to determine which of the three openings found is the vagina This feature allows the detection of the HPV virus through three openings found in women. This will allow the doctor to accurately determine which vaginal opening is the correct one. This process involves... To detect the lg l region, a color-changing litmus-like elastic sheath was used in the acidic area. (19) is done with the help of. In regional detection, the acidic nature of the urethra It is being used. The subject of the invention is the self-take of an HPV smear and the syringe (21) found in the result kit. The mechanism is shown in Figure 1. Accordingly, the subject of the invention is the self-administered HPV smear. The most basic way to activate and deactivate the injector (21) is by pressing 15 The movement key (1) can be used to take samples thanks to the mentioned push movement key (1). the indicator on the syringe (21) shows how far the rod needs to be advanced into the vaginal opening Liquid transfer device with red marker line (4) and elastic felt (8) at the end of the rod. It contains p ston (7). The subject of the invention is self-take of hpv-smear and the result kit. The injector (21) must contain at least one screw (2) and 20 v branch m le (2) rt batlı sample collection assisting piston tension spring (5) It is located. The mentioned piston return spring (5) is inside the injector (21) and rotates and It is connected with a nut (6). The subject of the invention is self-take of HPV-smear and result KT. Detailed parts of the injector (21) can be seen in Figure 1. The subject of the invention is the self-take of an HPV smear and the tip of the syringe (21) in the result kit 25 A detailed view of the part is given in Figure 1-2. As seen in Figure 1-2, the injector (21) The end section contains the liquid reservoir (12) and the sample collection section (11). Liquid reservoir (12) It contains a tissue-protective fluid. This tissue-protective fluid prevents drying and... It has properties that prevent bacterial growth. Thanks to this, the samples taken can be preserved for up to nine months. It can be kept without deterioration. Liquid transfer is done at the tip of the syringe (21) cp ston 30 (7) and elastic felt (8) are available. The elastic felt (8) used here was taken from the sample and It prevents the protective liquid from flowing out and back. With the mentioned elastic felt (8) The sample container (13) containing the liquid and brush is also available. 8 The subject of the invention is a self-take of HPV smear and the dropper tip with the result printed on it (9) The picture of the drip tip stopper (10) is given in Figure 3. Here the sample is tested drip tip (9) and drip tip stopper used to transfer to the rod (22) (10) is shown. The sample is taken on the test strip (22) inside the box. The dropper tip (9) is attached to the tip of the syringe (21) and liquid is dropped onto the test strip (22) 5 The results are evaluated in the test window. Figure 1-4 shows the external view of the injector (21) and the active state of the push button (1). It is given. The subject of the invention is self-administered HPV-smear and the result of the vaginal opening. The litmus-like elastic sheath (19) which is indicated as the part that detects is shown in Figure 4. It is shown. As can be seen in the image, the entire syringe (21) is made of litmus-like elastic 10 It is covered with a case (19). Figure 1-5 shows the external view of the injector (21) and the pass-through state of the push button (1). It is given. The injector (21) is inside when the push button (1) is active but It has a sample collector brush (20) which is used to collect samples by going out of the pass. The subject of the invention is the self-take HPV smear and result KT rapid test stick (22) Figure 15 It is given in Figure 1-6. The control line (14) on the mentioned rapid test strip (22) is HPV-16 gene anti-protective line (15), HPV-18 gene anti-protective line (16), sample view section (17) and QR Reading section (18) is available. In addition, since the invention comes as a package, the package includes: gloves, and an HPV smear. collection syringe (21), HPV-Smear collection rapid test strip (22), dropper tip (9), 20 drip tip stopper (10), barcode, information form, cleaning wipe and shipping bag It is located. The technical elements described above, and the subject of the invention, are self-testing for HPV. And the resulting KT package's working mechanism is as follows: First, the person undergoing the test must assume a suitable position. This position is usually 25 This can be done standing or lying down. Afterwards, hands should be washed thoroughly and the package closed. A non-sterile glove is placed inside. Then, the external genital area is examined from front to back. The area where the test will be applied is wiped with the cleaning wipe included in the package. This step is for the area where the test will be performed. It ensures that the surface is free from non-sterile external factors and is clean before the smear is taken. This creates. Implementing this step is crucial to reducing the risk of infection. Then 30 The test strip (22) and syringe (21) are removed from their sealed packaging. 9 The invention is quite useful for preventing women from confusing their urethra and vaginal openings. It offers a method. There are three openings in the female external reproductive organs. HPV virus The test is performed at the vaginal opening. Therefore, it is necessary to determine the difference between the urethra and the vagina. For this, the litmus-like elastic sheath (19) on the invention is used. The litmus mentioned The special elastic sheath (19) covers the entire injector (21). Thus, the relevant place 5 Sample collection from the vaginal opening is easy and without any difficulty during the detection phase. It can be realized. The mentioned litmus-like elastic sheath (19) changes color in an acidic environment. It has the ability to change. Due to the acidity of the urethra in the human body, the vaginal... The opening can be easily determined. Litmus-like elastic sheath (19) HPV-smear The process ensures the use of accurate transparency in medical procedures related to women's health. 10 This helps in taking the correct sample during the procedure and making the correct diagnosis. It is possible. After determining the vaginal opening, the most important thing is how far the syringe (21) is into the vaginal opening. Here, help from the red marker lines (4) on the syringe (21). It is taken. The person performing the test takes this red mark line (4) as the boundary and inserts the injector (21) into the vagina 15 should be advanced. To obtain the correct and sufficient amount of sample, the syringe (21) must first have litmus properties. With the help of the elastic sheath (19), the area that is fixed is marked with the red mark on the syringe (21). The lines (4) are advanced by taking the limit. Here, the pressing action on the injector (21) When button (1) is pressed, the sample collector brush (20) comes out and the finger pressing motion 20 When the button (1) is pulled, the brush goes inside. Sample collector brush used for sample collection. (20) It has soft and rounded edges. Thus, it eliminates the risk of bleeding and irritation and It enables the collection of a large number of samples. Each press and release of the push button (1) When the process is completed, the sample collector brush (20) moves both outwards and inwards, halfway. The turn also involves rotation. In order to obtain a sufficiently thin sample at this stage, a pressing motion of 25 is required. Press the button (1) three times. Here, the outward and inward movement is the press of the movement button (1). The piston pull spring (5) is made with the support of the branch (2) of the rt bat. Half turn The rotational movement is controlled by the button (1) and the branch (2) With its support, the left-right movable bearing (3) and the turning and thrust nut (6) play an active role. Turning and tightening nut (6) the movement and rotation of the sample collector brush (20) 30 It provides. The right-left movable bearing (3) used here is the push-action button (1) When pressed, the branch v returns to its old position (2) and friction n A movable bearing is used to prevent this. To be able to take a sufficient amount of sample into the syringe (21) which is activated by pressing the push button (1). The sample is collected with a soft-textured, brush-like sample collector brush (20) by pressing the button three times. The addition operation is performed. After this operation is completed, the push button (1) is pressed one last time. With the brush in the closed position, the injector (21) is removed from the vaginal opening. Removed from the vagina The liquid transfer from the tip of the syringe (21) is drawn into the liquid reservoir (7) (12) found in the compressed cell, tissue-preserving fluid sample collector brush (20) The sample container (13) containing the liquid and the brush is filled. After this stage The action is taken according to the decision of the person to whom the procedure is applied. If you wish to have a test done after the procedure, or if you want to contact a screening center, The syringe (21) from which we took the sample is placed in the sealed bag inside the kt package. Again 10 The barcode and information form found inside the package are filled out and affixed to this resealable bag. And they can be sent to cancer screening centers for examination. Those who want to take a test can get a self-tested HPV smear and the results included in the package. found, for the detection of HPV-16 and HPV-18 viruses, which are the most common in cervical cancer. They can use the improved test stick (22). On the test stick (22) HPV 16 and 18 eat 15 Antigen genes are present. Here, the procedure involves separating the sample from the vagina after it has been taken. The liquid on the syringe (21) is transferred to the cp ston (7). Afterwards, the sample tissue and cells located on the collecting brush (20) inside the fluid reservoir (12) Wait approximately 5 minutes for the preservative liquid to transfer. (Contained inside the kit package) The dropper tip (9) is attached to the tip of the test strip (22) and the sample section (17) 20 Five drops of liquid are squeezed out. Then, wait about half a minute for the result. After half a minute... If there is a single line on the test bar (22), this indicates the control line (14) and means negative. If the control line (14) and the HPV-16 gene antibody in the middle part are present, If the control line (15) becomes prominent, the sample is HPV-16 positive. If the control line (14) is prominent, the sample is positive. HPV-18 gene anti-protection line 25 which contains HPV-18 gene anti-protection near the gr section (17) (16) If the lesions are pronounced, it is HPV-18 positive. The invention concerns a test with a self-administered HPV smear and result data packet (NNBR) feature. The QR code on the bar (22) allows patients to access their health information on digital health platforms. The integrated system allows quick and easy access through the system. This makes it easier for patients to... This allows them to see the scan results instantly and share them with the relevant physicians. 30 In addition, the results of the sample analysis apparatus sent for examination are also included in the digital health report. They can easily track them through the platforms. This allows them to monitor patients' health status. Information is always up-to-date and accessible, thus enabling more effective delivery of healthcare services. They are all capable of facilitating things. This integrated system simplifies the work of both patients and healthcare professionals. It facilitates and accelerates communication, thus ensuring more effective treatment and follow-up. 35 11 The Industrial and Application Form of the Invention The subject of the invention is a type of cancer that is common among women and is not treatable. It is used to detect cervical cancer and also to determine the area where it will be applied. capable of doing it themselves and anywhere desired without needing an expert or doctor. The applicable method is self-testing for HPV and the results are related to the data package.

Claims

12 REQUESTS 1. The subject of the invention is a self-administered HPV smear and result packet, characterized by its unique properties. feature; - test strip (22) on which at least one sample result will be displayed, 5 - People who don't know their own bodies can get suitable results without needing an expert. They can easily apply it wherever they see it; the package includes one sample. injector to be used for purchase (21), - activate the syringe (21) in such a way as to allow the syringe (21) to take a sample and pass f hale get reb len en az br adet basma hareket anahtar (1), 10 - mentioned push-button movement key (1) sample collector with rt bat sample collector brush (20), - finding the vaginal opening during sample collection on the outer surface of the syringe (21) auxiliary litmus feature elastic case (19), - red mark 15 showing how far the syringe (21) will be advanced in the vaginal opening The line (4) is included.

2. Perform a self-test for HPV according to step 1 and the result packet will be a character test. ed c feature ğ ; on the mentioned test bar (22); - one control line (14), 20 - br number of HPV-16 gene anti-protective lines (15), - br number of HPV-18 gene anti-protective lines (16), - one sample section (17), - The patient's results are integrated into the preferred digital health platforms. QR 25 allows easy sharing of information with the relevant physician via the system. reading section (18) çermes d r.

3. In accordance with claim 1, self-testing for HPV and characterization of the result packet. ed c feature; preferably sufficiently press the push button (1) located on the injector (21). To collect a sample, press the button three times, then turn it both inwards and outwards, and rotate it half a turn for 30 seconds. Sample collector brush (20) that enables sample collection process Çermes Dr. 35 13 4. Self-testing and result collection according to request 1 or request 3. package nn character ze ed c feature ğ ; in the internal mechanism of the injector (21), mentioned The sample collector brush (20) can move in and out and rotate half a turn. providing v branch ml (2) containing d r.

5. Self-testing and result collection according to request 1 or request 3. package nn character ze ed c feature ğ ; right-drop left-movement bearing (3) together with by performing the task of making the branch mln (2) and the sample collector brush (20) real. It must contain at least one piston return spring (5).

6. Self-testing and result submission according to request 1 or request 3. package nn character ze ed c feature ğ ; sample collector brush (20) ler movement n and It must contain at least one turning and turning nut (6) that enables its rotation.

7. Self-testing and result submission according to request 1 or request 3. package nn character ze ed c feature ğ ; preferably movable to prevent friction. bearing used, when the push button (1) is pressed, the branch mln (2) old It must contain at least one right-left movable bearing (3) that enables it to reach its position.

8. Compliant with claim 1, self-testing for HPV and characterization of the result packet. ed c feature ğ ; the entire surface of the injector (21) the vaginal opening and urethra in the human body By utilizing the properties of the as dk, the color changes and thus the sample is taken. The area contains an elastic sheath (19) with litmus properties that can easily detect the area. 25 9. In accordance with claim 1, self-testing for HPV and characterization of the result packet. ed c feature ğ ; to the user to correctly position the injector (21) and test n correctly the distance that must be advanced in the vaginal opening to allow for application To indicate, it is marked with a red line (4). 30 10. Compliant with claim 1, self-testing for HPV and characterization of the result packet. ed c feature; sample collecting brush (20) for preparing the collected sample. tissue protective fluid found in the fluid reservoir (12) of the tissue and cells on it at least one liquid transfer piston 35 that ensures filling and protection of the sample. (7) çermes d r. 14 11. Compliant with claim 1, self-testing for HPV and characterization of the result packet. ed c feature ; if the test stick (22) is used, the prepared sample is placed on the stick drip tip (9) that enables the transfer and to close the drip tip (9) The used drip tip stopper (10) should be attached. 5

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