Thermo-responsive polymer-based method and diagnostic kit for the extraction, enrichment, and detection of HCV antigens via specific antibody conjugation
A thermo-responsive polymer-based method and diagnostic kit for HCV antigen detection address the inefficiencies in existing POC diagnostics by enabling efficient extraction and detection, thereby reducing unawareness and associated health issues.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Filing Date
- 2025-01-13
- Publication Date
- 2026-07-16
AI Technical Summary
Existing point-of-care (POC) diagnostic methods for Hepatitis C virus (HCV) are not adequately addressing the need for efficient extraction, enrichment, and detection of HCV antigens, particularly due to legal restrictions on patenting diagnostic methods in humans and animals, and there is a significant global unawareness of HCV infection leading to high incidence rates of chronic hepatitis C and hepatocellular carcinoma.
A thermo-responsive polymer-based method and diagnostic kit for the extraction, enrichment, and detection of HCV antigens using a conjugated mixture of HCV antibodies, specifically targeting Envelope 1 and Envelope 2, to enhance POC detection.
The method and kit provide efficient and effective extraction and detection of HCV antigens, improving awareness and potentially reducing the incidence of chronic hepatitis C and hepatocellular carcinoma by facilitating rapid and reliable diagnostic testing.
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Abstract
Description
THERMO-RESPONSIVE POLYMER-BASED METHOD AND DIAGNOSTIC KIT FOR THE EXTRACTION, ENRICHMENT, AND DETECTION OF HCV ANTIGENS VIA SPECIFIC ANTIBODY CONJUGATION
[0001] Technical Field: One step point of care (POC) detection kit of Hepatitis C virus using a conjugated mixture of HCV antibodies to Envelope 1, Envelope 2, A method for extraction, enrichment & detection of HCV antigens.
[0002]
[0003] Chronic hepatitis C virus (HCV) infection poses a significant global health burden, affecting approximately 58 million individuals worldwide. HCV is the primary cause of hepatocellular carcinoma (HCC), with an annual incidence rate of 3-8% in patients with cirrhosis [1]. Alarmingly, less than 5% of those infected are aware of their condition globally [2, 3].
[0004] A preceding patent application, titled "A Novel Rapid Diagnostic Test as a Point of Care for HCV Antigen Screening Using Nanoparticles," was submitted in December 2019. Unfortunately, the Egyptian Patent Office declined to grant the patent application No.2002 / 2019 pursuant to Article 2 of the Intellectual Property Protection Law No. 82 of 2002. This law excludes methods of diagnosis, treatment, and surgery in humans and animals from patent protection.Ref:
[0005] 1 - World Health Organization. Global hepatitis report, 2017 [Internet]. Geneva: World Health Organization; 2017. Available from: http: / www.who.int / hepatitis / publications / global-hepatitis-report2017 / en /
[0006] 2- World Health Organization. Global health sector strategy on viral hepatitis 2016–2021: Towards ending viral hepatitis. Geneva: WHO; 2016. p. 10-16.
[0007] 3- Stasi C, Silvestri C, Voller F. Update on Hepatitis C Epidemiology: Unaware and Untreated Infected Population Could Be the Key to Elimination. SN Compr Clin Med. 2020 Dec;2(12):2808-2815.
[0008] 4- World Health Organization. Updated Recommendations on Simplified Service Delivery and Diagnostics for Hepatitis C Infection [Internet]. Geneva: WHO; 2022. Available from: https: / www.who.int / publications-detail-redirect / 9789240052697.
[0009] 5- Freiman JM, Tran TM, Schumacher SG, White LF, Ongarello S, Cohn J, Easterbrook PJ, Linas BP, Denkinger CM. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med. 2016 Sep 6;165(5):345-55.
[0010]
Claims
A method for extraction, enrichment of HCV antigens, comprising:Conjugating specific HCV antibodies to Envelope 1, Envelope 2, Non-structural 3 (NS3), and Non-structural 4 (NS4) to a temperature-responsive smart polymer (NIPAAm-Co-HIPAAm-Co-SAKIPAAm); for extraction and enrichment HCV antigens in a blood sample using the conjugated antibodies.The method of claim 1, wherein the conjugation occurs before adding the reagents to the sampleThe method of claim 1, wherein the specific HCV antibodies are used alone or in combination or a mixture of allThe method of claim 1, wherein the conjugation is premadeA detection kit for HCV antigens, comprising: Temperature-responsive smart polymer (NIPAAm-Co-HIPAAm-Co-SAKIPAAm) conjugated to specific HCV antibodies; colloidal gold nanoparticles conjugated to specific HCV antibodies; instructions for detecting HCV antigens in serum, plasma, or whole blood samplesThe diagnostic kit of claim 5, wherein specific HCV antibodies are conjugated to the colloidal gold nanoparticles before adding to the sample.The extraction, enrichment and detection kit of claim 1 and 5, wherein the kit is used for detecting HCV antigens in serum, plasma, or whole blood samplesA method for extraction, enrichment and detection of viruses, bacteria, or fungi, comprising: Using the extraction, enrichment and detection kit of claim1 and 5; replacing the specific HCV antibodies with antibodies specific to the targeted pathogenUsing the method of claim 1 and 5, for detection of tumor markers, cell surface antigens and oncofetal antigensThe method of claim 1 and 5, wherein the targeted pathogen is selected from:RNA viruses (e.g., influenza, SARS, MERS, Covid-19, Dengue Virus) and any other RNA viruses in human and animals.DNA viruses (e.g., hepatitis B, papilloma, herpes) and any other DNA viruses in human and animals.Bacteria (e.g., Mycobacterium tuberculosis, E. coli, Salmonella) and any other bacteria in human and animals.Fungi in human and animals.