ABSTRACT
Background: Achievement of WHO goals for HCV elimination needs scaling up of diagnosis and treatment capacities in low-income and middle-income countries, where HCV is highly endemic. However, in these regions, access to HCV diagnostic tools is severely limited. The current diagnostic algorithm is based on using two steps;rapid diagnostic test (RDTs) and viral load confirmation. So there is a need for simple point of care (POC) test that can be done in the field. Recently, we developed a novel technology for extraction and enrichment of HCV antigen using temperature-sensitive Smart Polymer, which used previously For enabling affinity enrichment of current coronavirus (SARS-CoV- 2) to improve its diagnostic sensitivity Our aim is to design a novel method for extraction and enrichment of HCV antigen using temperature-responsive smart polymer 'NIPAAm-co- HIPAAm- co- SAKIPAAm' (Patent: 2019/2002) for enabling affinity enrichment of HCV antigen to be used as a part of POC test to improve the cascade of care Methods: We used temperature-responsive smart polymer 'NIPAAm-co- HIPAAm- co- SAKIPAAm' (Patent: 2019/2002) for extraction and enrichment HCV antigen for 15 positive HCV serum samples and 5 negative HCV serum samples confirmed by PCR technique. After extraction and enrichment of HCV antigen by temperature-responsive smart polymer 'NIPAAm-co- HIPAAm- co- SAKIPAAm' samples undergo amplification and detection by thermal cycler as amplification and detection of Rt-PCR technique (SLAN-96P Real-Time PCR System ). Result(s): . The time needed for extraction and enrichment of HCV Antigen using temperature-sensitive smart polymer (10mins) which is shorter than extraction time in RT-PCR ( One hour). The results showed that HCV antigen extracted and enriched by temperature-responsive smart polymer gave the same results with positive and negative HCV samples detected by PCR, Sensitivity 100%, Specificity 100% Conclusion(s): The novel temperature-responsive smart polymer 'NIPAAm-co- HIPAAm- co- SAKIPAAm' (Patent: 2019/2002) is able to extract and enrich HCV antigen in the same sensitivity and specificity like the current PCR. The time needed for this simple technique may make it be suitable to be a part of POC test for rapid, affordable, easy-to- use test in comparison to PCR technique which needs dedicated facilities and highly qualified personnel.