The Journal of infectious diseases · 2026
A novel decentralized rapid test for detection of HCV antigens using smart polymer technology: a prospective multinational study.
СтатьяНазвание и аннотация: Перевод в очереди
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Shiha Gamal, Ebara Mitsuhiro, Hassan Ayman, Toyoda Hidenorie, Abdelsameea Mohamed, Osama Khalifa Yosra, Galbt Hossam, Abdelsameea Eman, Farahat Ahmed, Ziada Dina H, Magdy Fahmy Madonna, Ali Choudhry Asad, Chaudhry Auj, Asad Hafsa, Nabil Ahmed, Picchio Gaston, Soliman Riham
Аннотация
BACKGROUND: There is an unmet need for a rapid, affordable, and highly sensitive point-of-care HCV antigen test suitable for decentralized settings. We developed SMART-C, a lateral-flow assay integrating a thermo-responsive smart polymer for HCV antigen extraction and enrichment with colloidal gold nanoparticles. We evaluated its diagnostic performance against the Cobas® 6800 HCV RNA PCR assay as the reference standard.
METHODS: A multinational, multicentre, prospective diagnostic accuracy study was conducted during 2022-2026 at hospital and field sites in Egypt, Pakistan, and Japan. Paired serum/plasma samples from venous blood were tested blindly using SMART-C and quantitative HCV RNA PCR. Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were calculated following STARD guidelines. Additionally, 21 patients initiating direct-acting antiviral (DAA) therapy were prospectively followed to assess SMART-C performance during treatment and after viral clearance.
RESULTS: Among 1,353 paired samples from a high-risk clinical cohort, SMART-C demonstrated 94.6% sensitivity (474/501; 95% CI, 92.3-96.3) and 91.3% specificity (778/852; 95% CI, 89.2-93.0), with 92.5% accuracy, 86.5% PPV, and 96.6% NPV. Agreement with PCR was high (κ=0.843). SMART-C paralleled PCR-defined viral decline during DAA therapy and became negative concordantly with PCR clearance in 19/21 patients.
CONCLUSION: SMART-C achieved an analytical limit of detection below 10 IU/mL, approaching that of the Cobas® 6800 PCR assay (∼10 IU/mL). Its high diagnostic performance and simple lateral-flow format support its potential for decentralized HCV testing and contribution to WHO hepatitis C elimination goals.
METHODS: A multinational, multicentre, prospective diagnostic accuracy study was conducted during 2022-2026 at hospital and field sites in Egypt, Pakistan, and Japan. Paired serum/plasma samples from venous blood were tested blindly using SMART-C and quantitative HCV RNA PCR. Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were calculated following STARD guidelines. Additionally, 21 patients initiating direct-acting antiviral (DAA) therapy were prospectively followed to assess SMART-C performance during treatment and after viral clearance.
RESULTS: Among 1,353 paired samples from a high-risk clinical cohort, SMART-C demonstrated 94.6% sensitivity (474/501; 95% CI, 92.3-96.3) and 91.3% specificity (778/852; 95% CI, 89.2-93.0), with 92.5% accuracy, 86.5% PPV, and 96.6% NPV. Agreement with PCR was high (κ=0.843). SMART-C paralleled PCR-defined viral decline during DAA therapy and became negative concordantly with PCR clearance in 19/21 patients.
CONCLUSION: SMART-C achieved an analytical limit of detection below 10 IU/mL, approaching that of the Cobas® 6800 PCR assay (∼10 IU/mL). Its high diagnostic performance and simple lateral-flow format support its potential for decentralized HCV testing and contribution to WHO hepatitis C elimination goals.