The signal-to-cutoff ratios to predict HCV infection among people who inject drugs

Abstract

People who inject drugs (PWIDs) are primarily the high-risk population for HCV infection. This study aims to determine the optimal cut-off values for predicting HCV infection status based on the Signal-to-Cutoff (S/CO) ratio. In this study, a total of 719 PWIDs’ samples were collected, and performed for screening test by ELISA assay, and followed by RIBA assay and NAT assay to detect HCV antibody and HCV RNA levels, respectively. The findings revealed that the prevalence of HCV infection among PWIDs was 54.66% (393/719), and the false-positive rate of HCV antibody detection by ELISA assay among PWIDs was only 3.85% (16/416). In addition, when the optimal cut-off value for S/CO ratio was 2.0, the sensitivity and specificity of HCV antibody were 100.00% and 93.55%, respectively. And when the optimal cut-off value for S/CO ratio was 21.36, the sensitivity and specificity of HCV RNA positive were 89.90% and 72.73%, respectively. In conclusion, the status of HCV infection can be predicted based on the S/CO ratios of the ELISA assay, which can improve diagnosis and facilitate timely treatment to effectively prevent the spread of HCV infection.

Comparison of effectiveness and cost of different HCV testing strategies in high‐risk populations in China

“…Screening the high‐risk population plays a crucial role in effectively controlling the transmission of HCV, as this population is particularly susceptible to infection 16‐19 . By implementing comprehensive and widespread screening measures among high‐risk groups, it becomes possible to identify potential HCV infections at an early stage 20 .…”

“…Screening the high-risk population plays a crucial role in effectively controlling the transmission of HCV, as this population is particularly susceptible to infection. [16][17][18][19] By implementing comprehensive and widespread screening measures among high-risk groups, it becomes possible to identify potential HCV infections at an early stage. 20 This early detection enables prompt intervention and treatment, leading to improved health outcomes and preventing further transmission of the virus.…”

Glycylglycine promotes the solubility and antigenic utility of recombinant HCV structural proteins in a point-of-care immunoassay for detection of active viremia

“…Yet, most of the reported S/Co values that predict active HCV viremia were discrepant, with high cutoff values range between 5 and 21 [ 41 , 44 ]. Besides the potential incidences of false positive results associated with such high S/Co threshold [ 42 , 44 ], it may also produce false negatives especially during the seroconversion period and/or in immunocompromised patients. In the same line, the OD 450 of patients’ sera assayed in both denatured/soluble proteins-based immunoassays were normalized by calculating the S/Co values to nullify the effect of discrepant cutoffs, and further assess the antigenic performance of both antigen preparations against different panels of sera.…”

“…While the lack of statistically defined endpoint titer determination generally represents a major obstacle in antibody detection-based diagnostics, the usefulness of the signal-to-cutoff ratio (S/Co ratio) for predicting HCV infection has been approached in several studies [41][42][43][44]. Yet, most of the reported S/Co values that predict active HCV viremia were discrepant, with high cutoff values range between 5 and 21 [41,44].…”

“…While the lack of statistically defined endpoint titer determination generally represents a major obstacle in antibody detection-based diagnostics, the usefulness of the signal-to-cutoff ratio (S/Co ratio) for predicting HCV infection has been approached in several studies [41][42][43][44]. Yet, most of the reported S/Co values that predict active HCV viremia were discrepant, with high cutoff values range between 5 and 21 [41,44]. Besides the potential incidences of false positive results associated with such high S/Co threshold [42,44], it may also produce false negatives especially during the seroconversion period and/or in immunocompromised patients.…”