WO-2026093735-A1 - MODULATION OF POVIDONE-IODINE (PVP-I) ACTIVITY; ANTIMICROBIAL EFFICACY AND MOLECULAR DIAGNOSTIC COMPATIBILITY

Abstract

The present invention relates to kits, methods and systems for modulating free iodine in PVP-I, facilitating antimicrobial action while also ensuring compatibility with diagnostic assays.

Inventors

• COBB, BEN
• ALEXAKOU, Aikaterini

Assignees

• Readygo Diagnostics Limited

Dates

Publication Date

20260507

Application Date

20251028

Priority Date

20241028

Claims (14)

1. 1. A kit for biological sample processing and microbial inactivation said kit comprising: a. A sample collection device comprising a porous carrier pre-treated with a dried Povidone-lodine (PVP-I) formulation; b. A lysis buffer that rehydrates the PVP-I upon sample absorption, releasing antimicrobial iodine species for microbial lysis; c. A neutralising buffer configured to neutralise free molecular iodine (l 2 ).
2. 2. The kit of claim 1 , wherein the PVP-I formulation is dried into the carrier material.
3. 3. The kit of any preceding claim, wherein the lysis buffer maintains a pH range of 5.0 to 9.0 during the lysis phase.
4. 4. The kit of claim 3, wherein the lysis buffer maintains a pH range of 6.0 to 6.5 during the lysis phase.
5. 5. The kit of any preceding claim, wherein the neutralising buffer comprises sodium thiosulfate.
6. 6. The kit of any preceding claim, wherein the neutralising buffer raises the pH of the sample to above 8.
7. 7. A method for collecting and processing biological samples for diagnostic purposes, comprising: a. Collecting a sample with a porous carrier pre-treated with PVP-I; b. Rehydrating the PVP-I with a lysis buffer to release iodine species for microbial inactivation; c. Neutralising free molecular iodine (l 2 ) with a neutralising buffer.
8. 8. A method for processing biological samples for microbial inactivation and diagnostic testing, comprising: a. adding a Povidone-lodine (PVP-I) lysis buffer solution to the biological sample which releases iodine species; b. Allowing the iodine species to lyse microorganisms within the sample; c. Adding a post-lysis neutralising buffer.
9. 9. The method of claim 7 or 8, wherein the iodine species, includes molecular iodine (l 2 ), hypoiodous acid (HOI), and triiodide ion (l 3 “).
10. 10. The method of claim 7 or 8, wherein the neutralising buffer comprises sodium thiosulfate.
11. 11. The method of claim 7, 8 or 10, wherein the neutralising buffer raises the pH of the sample to above 8.0.
12. 12. A system for diagnostic processing of biological samples, comprising: a. A Povidone-lodine (PVP-I) lysis buffer solution which is added to the sample, initiating microbial lysis through iodine activity; b. A neutralising buffer configured to neutralise free iodine.
13. 13. The system of claim 12, wherein the pH of the lysis buffer is in the range of 6.0-6.5.
14. 14. The system of claim 12, wherein the neutralising buffer comprises sodium thiosulphate.

Description

Modulation of Povidone-iodine (PVP-I) Activity; Antimicrobial Efficacy and Molecular Diagnostic Compatibility Background of the Invention Povidone-iodine (PVP-I) is a widely recognised antiseptic agent and has been extensively used for its broad-spectrum efficacy against bacteria, viruses, fungi, and protozoa. Traditionally, PVP-I has been applied topically for wound care and disinfection. Its lysing properties suggest its application could be extended to diagnostic and therapeutic devices, especially where rapid microbial lysis is required without interference with downstream molecular diagnostic techniques such as PCR (Polymerase Chain Reaction) or LAMP (Loop- mediated Isothermal Amplification). A key challenge in applying PVP-I in molecular diagnostic contexts is mitigating the interference of free iodine, the key antimicrobial active agent, with the amplification reaction. The present invention addresses this challenge by providing a system that modulates the iodine in PVP-I so that it has both antimicrobial action while also ensuring compatibility with diagnostic processes such as PCR and LAMP. Summary of the Invention The present invention provides a system and method for using PVP-I to achieve rapid microbial lysis in biological samples while also providing compatibility with diagnostic assays, particularly those that use fluorescence-based detection. The invention regulates the release of iodine species such as molecular iodine (l2), hypoiodous acid (HOI), and triiodide ion (l3“), ensuring broad-spectrum antimicrobial efficacy. The system can optionally employ a porous carrier-based sample collection device that is pre-treated with PVP-I and dried. A post-lysis buffer then neutralises iodine to ensure that downstream diagnostics are not affected for example through fluorescence attenuation due to residual molecular iodine. In a first aspect of the invention, there is provided a sample collection device for biological sample processing and microbial inactivation comprising: a. A porous carrier pre-treated with a dried Povidone-iodine (PVP-I) formulation; b. A buffer system that rehydrates the PVP-I upon sample absorption, releasing antimicrobial iodine species for microbial lysis; c. A post-lysis buffer configured to neutralise free molecular iodine (l2), preventing interference with diagnostic assays. In a preferred embodiment, the PVP-I formulation is dried into the carrier material and rehydrated by the biological sample to release iodine species, including molecular iodine (l2) and hypoiodous acid (HOI), for broad-spectrum antimicrobial action. In some embodiments, the buffer system maintains a pH range of 5.0 to 9.0, preferably, a pH in the range of 6.0 to 6.5 during the lysis phase, optimising the balance between elemental iodine (l2) and hypoiodous acid (HOI). In an embodiment, the post-lysis buffer, also referred to herein as the neutralising buffer, comprises sodium thiosulfate to neutralise molecular iodine (l2) species, ensuring diagnostic compatibility by minimising fluorescence attenuation in PCR or LAMP assays or interreference of enzymatic processivity. Preferably, the neutralising buffer raises the pH of the sample, thereby shifting the iodine species equilibrium toward non-interfering forms such as iodide (I"). In another aspect of the invention, there is provided method for collecting and processing biological samples for diagnostic purposes, comprising: a. Collecting a sample with a porous carrier pre-treated with PVP-I; b. Rehydrating the PVP-I to release iodine species for microbial inactivation; c. Neutralising free molecular iodine (l2) with a buffer to prevent interference with diagnostic assays. In another aspect of the invention there is provided a method for processing biological samples for microbial inactivation and diagnostic testing, comprising: a. Directly adding a Povidone-lodine (PVP-I) solution to the biological sample; b. Allowing the iodine species to lyse microorganisms within the sample; c. Adding a post-lysis neutralising buffer to convert residual molecular iodine (l2) into non-interfering species. In a preferred embodiment, the PVP-I releases iodine species, including molecular iodine (l2), hypoiodous acid (HOI), and triiodide ion (l3“), upon addition to the sample, providing broad-spectrum antimicrobial action. In an embodiment, the post-lysis buffer, or neutralising buffer, comprises sodium thiosulfate to neutralise molecular iodine (l2) species, ensuring diagnostic compatibility by minimising fluorescence attenuation in PCR or LAMP assays or interreference of enzymatic processivity. Preferably, the neutralising buffer raises the pH of the sample to above 8.0, thereby shifting the iodine species equilibrium toward non-interfering forms such as iodide (I’). In another aspect of the invention, there is a provided a system for diagnostic processing of biological samples, comprising: a. A Povidone-lodine (PVP-I) solution is added to the sample, initiating m