Key result
The RT-RAA-LFD assay showed 100% positive and negative concordance rates with qPCR for detecting HCV in 46 anti-HCV antibody-positive clinical samples.
Why the study?
Precise disease diagnosis is required to reach the WHO objective of eliminating viral hepatitis by 2030, highlighting the need for rapid and accurate point-of-care testing to detect HCV.
Does the RT-RAA-LFD assay accurately and rapidly detect HCV compared to qPCR?
Does the RT-RAA-LFD assay accurately and rapidly detect HCV compared to qPCR?
The RT-RAA-LFD assay provides a rapid, specific, and sensitive point-of-care testing method for HCV detection, suitable for use in community and remote settings.
May support rapid HCV testing in remote settings; larger validation studies needed before clinical adoption.
Hepatitis C virus (HCV) infection is a global public health threat. Reaching the World Health Organization's objective for eliminating viral hepatitis by 2030 will require a precise disease diagnosis. While immunoassays and qPCR play a significant role in detecting HCV, rapid and accurate point-of-care testing is important for pathogen identification. This study establishes a reverse transcription recombinase-aided amplification-lateral flow dipstick (RT-RAA-LFD) assay to detect HCV. The intact workflow was completed within 30 min, and the detection limit for synthesized C/E1 plasmid gene-containing plasmid was 10 copies/μl. In addition, the test showed good specificity, with no cross-reactivity observed for hepatitis A virus, hepatitis B virus, HIV, syphilis, and human papillomavirus virus. Using extracted RNAs from 46 anti-HCV antibody-positive samples, RT-RAA-LFD showed 100% positive and negative concordance rates with qPCR. In summary, the RT-RAA-LFD assay established in this study is suitable for the rapid clinical detection of HCV at the community level and in remote areas.
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Wang et al. (2022) studied Hepatitis C Virus (HCV) infection (n=46). Reverse transcription recombinase-aided amplification-lateral flow dipstick (RT-RAA-LFD) vs. Quantitative real-time PCR (qPCR) was evaluated on Concordance rate with qPCR. The RT-RAA-LFD assay showed 100% positive and negative concordance rates with qPCR for detecting HCV in 46 anti-HCV antibody-positive clinical samples.
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