Search

BR-102025013182-A2 - SYSTEM FOR TESTING FEMALE REPRODUCTIVE HEALTH AND DIAGNOSTIC METHOD

BR102025013182A2BR 102025013182 A2BR102025013182 A2BR 102025013182A2BR-102025013182-A2

Abstract

This disclosure provides a system for testing a state of female vaginal health, including a collection element (103, 101, 107) for collecting female vaginal secretion, wherein the collection element covers an external surface of a vagina instead of entering the vagina and is capable of absorbing the vaginal secretion; and a test element (102) for testing an analyte in the collected vaginal secretion or a property of the analyte to assess a state of vaginal health based on a test result obtained by the test element.

Inventors

  • GUOHUI ZHOU
  • LIQUN FENG
  • Jing Yang

Assignees

  • JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD.

Dates

Publication Date
20260310
Application Date
20250625
Priority Date
20240625

Claims (20)

  1. 1 - SYSTEM FOR TESTING AN ANALYTE IN A FEMALE VAGINAL SECRETION, characterized in that a collection element for collecting a female vaginal secretion, wherein the collection element (103, 101, 107) covers an external surface of a vagina instead of entering the vagina, which is configured to absorb the vaginal secretion; and a test element (102) for testing an analyte in the collected vaginal secretion or a property of the vaginal secretion, wherein a test result obtained by the test element is defined to assess whether the vagina is in a healthy state.
  2. 2 - SYSTEM, according to claim 1, characterized in that the collection element comprises a sheet-like absorbent material (103, 101) covering the external surface of the vagina and is used to absorb vaginal secretion from the vagina.
  3. 3 - SYSTEM, according to claim 2, characterized in that the sheet-like absorbent material comprises a feminine sanitary pad (103, 101, 107, 104) or a urine absorbent pad and the feminine sanitary pad is configured to cover the surface of the female vagina for a specified time.
  4. 4 - SYSTEM, according to claim 3, characterized in that the time is from 2 to 20 hours and the time to cover is before bedtime at night.
  5. 5 - SYSTEM, according to claim 4, characterized in that the sanitary pad is provided with different areas (1014, 1015, 1016) and one area is capable of being detached from the female sanitary pad to be used as test samples.
  6. 6 - SYSTEM, according to claim 5, characterized by the fact that the different areas of the feminine sanitary pad are capable of being directly cut to obtain partial samples.
  7. 7 - SYSTEM, according to claim 6, characterized in that the sanitary pad comprises a first layer (103) and a second layer (101), a loose layer (107) for absorbing a sample is disposed between the first layer and the second layer and the first layer and the second layer are dense absorbent layers.
  8. 8 - SYSTEM, according to claim 7, characterized in that the loose layer (107) is capable of being pulled out or separated from between the second (101) and the first layer (103).
  9. 9 - SYSTEM, according to claim 7, characterized in that the first layer (103) has a front surface (1031) and a back surface (1032), the second layer (101) also has a front surface (1012) and a back surface (1011) and the loose layer (107) is capable of being fixed to the front surface of the first layer (1031) or to the front surface of the second layer (1012).
  10. 10 - SYSTEM, according to claim 9, characterized in that the back surface (1032) of the first layer (103) has an adhesive layer (104) for adhering the sanitary pad to underwear or to skin around the vagina.
  11. 11 - SYSTEM, according to claim 10, characterized in that the test element comprises a nucleic acid test element (063), an immunoassay element or a biochemical test element (060, 062).
  12. 12 - SYSTEM, according to claim 11, characterized in that the nucleic acid test element is used to test for the quantity or presence or absence of a target nucleic acid in female vaginal secretion and, preferably, the target nucleic acid comprises a virus, a bacterium or a fungus, more preferably a virus.
  13. 13 - SYSTEM, according to claim 12, characterized in that the virus is human papillomavirus (HPV) or a sexually transmitted disease (STD).
  14. 14 - SYSTEM, according to claim 13, characterized in that the STD comprises syphilis, condyloma acuminata, acquired immune deficiency syndrome or gonorrhea.
  15. 15 - SYSTEM, according to claim 14, characterized in that the nucleic acid test element comprises reagents necessary for polymerase chain reaction (PCR), isothermal nucleic acid amplification (063).
  16. 16 - SYSTEM, according to claim 13, characterized in that the system further comprises a nucleic acid extraction reagent for extracting nucleic acid from the loose layer (107) of the sanitary pad.
  17. 17 - SYSTEM, according to claim 11, characterized in that the biochemical test or immunoassay is for testing for a viral antigen or oxidase, hydrogen peroxide, leukocyte esterase, sialidase, β-glucuronidase, acetylglucosaminidase or a pH value in the analyte (102).
  18. 18 - METHOD FOR TESTING AN ANALYTE IN A VAGINAL SECRETION, characterized in that it comprises: covering an external surface of a vagina with a sheet-like element comprising an absorbent material for a specific time to absorb a vaginal secretion from the vagina; and removing the sheet-like element and then removing a portion of the absorbent material comprising the secretion from the sheet-like element to test an analyte in the female vaginal secretion.
  19. 19 - METHOD, according to claim 18, characterized in that the leaf-like element is a feminine sanitary pad.
  20. 20 - METHOD, according to claim 18, characterized in that the removal comprises cutting the sheet-like absorbent material from the sheet-like element or tearing the sheet-like absorbent material from the sheet-like element.

Description

Cross-referencing related requests [01] This disclosure claims priority to Prior Chinese Patent Application No. 2024108775469, filed June 25, 2024 and U.S. Provisional Patent Application No. 63/669,982, filed July 11, 2024, the entire content of which is incorporated herein as part of this disclosure, including, but not limited to, the descriptive report, abstract, claims and figures. Technological sector of invention [02] The present disclosure relates to a device for collecting a liquid sample and a test device and, specifically, to a device for testing an analyte in a liquid sample in the field of rapid diagnostics, such as a system or method for testing an analyte in urine or in a female vaginal secretion or a property of the analyte. Known state of the art [03] The following description of the history of the art is merely an introduction to some common historical knowledge and should not represent any limitation to the present invention. [04] In healthy women, the vagina has a natural defense function against the invasion of pathogens due to the characteristics of its anatomical tissues. For example, the closure of the vaginal introitus, keratinization of epithelial cells, and the maintenance of vaginal acidity at a pH of 4 to 5 inhibit the proliferation of pathogens adapted to an alkaline environment, such as anaerobic bacteria. When the vagina's natural defense function is damaged, pathogens can easily invade, leading to vaginal inflammation. [05] Vaginal inflammation is a common and frequently occurring disease in women. In addition to causing symptoms of vulvovaginal discomfort in patients, it can also lead to a number of serious complications related to reproductive health, threatening female reproductive health. Common vaginal inflammations include bacterial vaginosis (BV), aerobic vaginitis (AV), trichomoniasis, vulvovaginal candidiasis (VVC), and similar conditions. [06] The female vaginal microsystem is a component of the human microsystem and consists of vaginal microbial flora, an endocrine regulatory system, a vaginal anatomical structure, and a local immune system. Vaginal microbial flora are diverse, exhibiting mutual symbiosis and antagonism between species. Influenced by various internal and external factors, they participate in the formation of a structurally complex microsystem. In a normal vaginal microbial flora, lactobacillus serves as a dominant bacterium, which may coexist with a small number of other diverse bacteria. Vaginal lactobacilli play an essential role in maintaining normal vaginal flora. Glycogen in the vaginal epithelium is broken down into lactic acid by lactobacilli, creating a weakly acidic local environment in the vagina. The following situations potentially disrupt the balance of the vaginal ecosystem: (1) Sex hormones: for example, decreased estrogen levels before and after menstruation can lead to an increase in vaginal pH, favoring the growth of anaerobic bacteria. (2) Some spermicidal contraceptives: have toxic effects on lactobacilli. (3) Medications: many medications, such as broad-spectrum antibiotics, can kill or inhibit lactobacilli, thus affecting the vaginal environment. (4) Infection: for example, promiscuity can disrupt the original vaginal flora, leading to dysbiosis. When the vaginal microecological balance is disturbed, changes characterized by abnormal vaginal flora and vaginal pH can occur. This represents a tendency that can reduce the vagina's resistance to pathogenic microorganisms, leading to secondary infections. In addition, when infected with some communicable diseases, such as acquired immunodeficiency syndrome and human papillomavirus (HPV), symptoms may also appear in the female vagina. [07] Whether it is the test properties of female vaginal secretions, for example, pH or the amount of an analyte, for example, oxidase test, hydrogen peroxide, leukocyte esterase, sialidase, β-glucuronidase, acetylglucosaminidase or a pH value, sampling of vaginal secretions is necessary before performing the analysis. [08] In traditional sampling, for example, the sampler disclosed in WO2015190738A1 has a tube with an open back and a closed front end, providing an internal space into which a finger can be inserted into the female vagina to sample a secretion inside the vagina. A vaginal autosampler includes a collecting part housed in a sheath at a closed end of a tube and configured to collect a cervical sample, typically called a “vaginal swab,” for example, a cotton swab. Such samplers require inserting part of the structure deep into the vagina, which can cause damage to vaginal tissues. Furthermore, traditional sampling methods require testers to perform the operation themselves, which can cause discomfort and is not user-friendly. Specifically, autosampling is more complicated and the sampling is insufficient. In addition, during sampling, most testers do not insert the sampler deep enough into the vagina, instead lightly rubbing the external sur