Evaluation of Signal/Cut-off Ratio by Anti-hepatitis Delta Virus Enzyme Immunoassay Method in the Diagnosis of Hepatitis Delta Virus Infection

Abstract

Amaç: Hepatit delta virüsü (HDV), Deltavirus genusunda, zarflı, negatif polariteli, tek iplikli bir RNA virüsüdür. Bu çalışmada, anti-HDV pozitif olan hastalarda HDV enfeksiyonu tanısında anti-HDV sinyal/ cutoff (S/CO) oranının değerlendirilmesi amaçlandı. Gereç ve Yöntemler: Ağustos 2014-Aralık 2018 tarihleri arasında hepatit B yüzey antijeni (HBsAg) ve anti-HDV pozitif saptanan ve HDV-RNA testi çalışılmış toplam 156 hasta çalışmaya dahil edildi. Anti-HDV antikoru ve HBsAg testleri serum örneklerinde mikro-ELISA yöntemi ile, HDV-RNA testi ise plazma örneklerinde real-time polimeraz zincir reaksiyonu yöntemi ile çalışıldı. Bulgular: Anti-HDV pozitif hastaların %42,9'unda (67/156) HDV-RNA saptandı. HDV-RNA pozitif grubun anti-HDV S/CO ortalaması (8,99±3,53), HDV-RNA negatif gruba (5,99±3,73) göre anlamlı olarak yüksek saptandı (p<0,001). Alıcı işletim karakteristiği (ROC) analizi ile S/CO değeri 6,13 belirlendiğinde; duyarlılık, özgüllük, pozitif ve negatif prediktif değerler sırasıyla %79,

Hepatitis D Infection in Asia: A Perspective From an Endemic Region

“…Anti-HDV was investigated semiquantitatively by determining the signal/cutoff (S/CO) ratio; in addition to anti-HDV ELISA results, reporting of the S/CO ratio and determining each laboratory's optimal cutoff value may be helpful for the accurate diagnosis of HDV infection. 10 Recently, a new serological test (a novel quantitative microarray antibody capture [Q-MAC] assay) has been developed, with higher sensitivity in antibody measurement and viremia detection compared with current ELISA tests across the different HDV genotypes. The Q-MAC assay's sensitivity was 10 6 -and 10 3 -fold higher than the commercial anti-HDV immunoglobulin G ELISA kit and western blot analysis.…”

“…Although the sensitivity of ELISA tests is high, populations with low prevalence have lower positive predictive values and higher false positivity rates. Anti‐HDV was investigated semiquantitatively by determining the signal/cutoff (S/CO) ratio; in addition to anti‐HDV ELISA results, reporting of the S/CO ratio and determining each laboratory’s optimal cutoff value may be helpful for the accurate diagnosis of HDV infection 10 . Recently, a new serological test (a novel quantitative microarray antibody capture [Q‐MAC] assay) has been developed, with higher sensitivity in antibody measurement and viremia detection compared with current ELISA tests across the different HDV genotypes.…”