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High antibody level: an accurate serologic marker of viremia in asymptomatic people with hepatitis C infection
Author(s) -
Contreras Ana M.,
OchoaJiménez Rodolfo J.,
Celis Alfredo,
Méndez Claudia,
Olivares Laura,
Rebolledo Claudia E.,
HernandezLugo Isabel,
AguirreZavala Ana I.,
JiménezMéndez Ricardo,
Chung Raymond T.
Publication year - 2010
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2009.02571.x
Subject(s) - viremia , asymptomatic , medicine , serology , hepatitis c virus , antibody , gold standard (test) , hepatitis c , immunology , nucleic acid test , liter , virology , confidence interval , gastroenterology , virus , disease , covid-19 , infectious disease (medical specialty)
BACKGROUND: The screening and diagnosis of hepatitis C virus (HCV) infection is initiated by testing for antibody to HCV (anti‐HCV). A positive anti‐HCV test in blood donors represents ongoing infection in only a variable proportion of individuals. Because a high anti‐HCV level has been associated with viremia, a study was conducted to determine whether a high antibody level is an accurate serologic marker for viremia in asymptomatic anti‐HCV–positive persons. STUDY DESIGN AND METHODS: In a diagnostic test study, we included 856 anti‐HCV–positive blood donors in a blood bank at Guadalajara, Jalisco, Mexico, between 2002 and 2007. A third‐generation amplified chemiluminescence assay (ChLIA HCV) was used to detect anti‐HCV. A positive result of the qualitative nucleic acid test (HCV RNA) was considered the gold standard for viremia. RESULTS: By receiver operating characteristic analysis, the signal‐to‐cutoff (S/CO) ratio of 20 or more was chosen as optimal to identify viremia and so was defined as high anti‐HCV level. There was a significant difference in the proportion of viremia between subjects with high antibody level and those with lower levels (93.7% vs. 1.8%, respectively; p < 0.001). A high antibody level showed a sensitivity for viremia of 96.6% (95% confidence interval [CI], 93.8%‐98.1%), a specificity of 96.6 % (95% CI, 94.8%‐97.8%), and a likelihood ratio of 28.6 (95% CI, 18.4%‐44.6%). CONCLUSION: A high antibody level (S/CO ratio ≥20 by ChLIA HCV) clearly divides the viremic from the nonviremic blood donors and functions as an accurate serologic marker to guide the use of routine HCV RNA testing to confirm hepatitis C infection.