Clinical usefulness of HCV core antigen assay for the management of patients with chronic hepatitis C. 2014

Dragos Florea, and Emil Neaga, and Ionelia Nicolae, and Daniela Maxim, and Madalina Popa, and Dan Otelea
Prof Dr Matei Bals National Institute for Infectious Diseases;Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. dragos.florea@mateibals.ro.

OBJECTIVE The study aimed to evaluate the clinical utility of the chemiluminescent HCV core Ag test compared to viral load assessment in the management of patients with chronic hepatitis C. METHODS A retrospective study was performed at a tertiary-care infectious diseases hospital on samples collected from anti-HCV positive patients. Seventy-six samples were tested with the Architect HCV core Antigen kit and Cobas AmpliPrep/Cobas Taqman HCV kit. The HCV Ag test accuracy was estimated using data from all the HCV RNA tested samples received between January 2011 and December 2012. RESULTS The HCV Ag test showed a good correlation between the logarithmic values of HCV RNA and HCV Ag (R=0.98), with a 100% specificity and PPV, but with reduced sensitivity for viral loads lower than 1,000 UI/mL. In a model using data from 2,478 HCV RNA tested samples and a cut-off of the Ag assay corresponding to 1,000 UI/mL HCV RNA, the Ag test would have a sensitivity of 82.4%, a NPV of 80.9% and a high specificity and PPV (100%) compared to the viral load. The sensitivity would be higher for baseline evaluation compared to on-treatment samples (98.5 vs. 50%). The highest NPV (98%) would be obtained at 48 and 72 weeks after the initiation of treatment, with a sensitivity of 88.2% and 96.1%, respectively. CONCLUSIONS The Architect HCV core Ag assay might be an alternative for the diagnosis of active HCV infection if molecular tests are not available, and a useful method for the evaluation of sustained virological response in treated patients.

UI MeSH Term Description Entries
D011237 Predictive Value of Tests In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test. Negative Predictive Value,Positive Predictive Value,Predictive Value Of Test,Predictive Values Of Tests,Negative Predictive Values,Positive Predictive Values,Predictive Value, Negative,Predictive Value, Positive
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000998 Antiviral Agents Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. Antiviral,Antiviral Agent,Antiviral Drug,Antivirals,Antiviral Drugs,Agent, Antiviral,Agents, Antiviral,Drug, Antiviral,Drugs, Antiviral
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015415 Biomarkers Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, ENVIRONMENTAL EXPOSURE and its effects, disease diagnosis; METABOLIC PROCESSES; SUBSTANCE ABUSE; PREGNANCY; cell line development; EPIDEMIOLOGIC STUDIES; etc. Biochemical Markers,Biological Markers,Biomarker,Clinical Markers,Immunologic Markers,Laboratory Markers,Markers, Biochemical,Markers, Biological,Markers, Clinical,Markers, Immunologic,Markers, Laboratory,Markers, Serum,Markers, Surrogate,Markers, Viral,Serum Markers,Surrogate Markers,Viral Markers,Biochemical Marker,Biologic Marker,Biologic Markers,Clinical Marker,Immune Marker,Immune Markers,Immunologic Marker,Laboratory Marker,Marker, Biochemical,Marker, Biological,Marker, Clinical,Marker, Immunologic,Marker, Laboratory,Marker, Serum,Marker, Surrogate,Serum Marker,Surrogate End Point,Surrogate End Points,Surrogate Endpoint,Surrogate Endpoints,Surrogate Marker,Viral Marker,Biological Marker,End Point, Surrogate,End Points, Surrogate,Endpoint, Surrogate,Endpoints, Surrogate,Marker, Biologic,Marker, Immune,Marker, Viral,Markers, Biologic,Markers, Immune
D016174 Hepacivirus A genus of FLAVIVIRIDAE causing parenterally-transmitted HEPATITIS C which is associated with transfusions and drug abuse. Hepatitis C virus is the type species. Hepatitis C virus,Hepatitis C-Like Viruses,Hepaciviruses,Hepatitis C Like Viruses,Hepatitis C viruses,Hepatitis C-Like Virus
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D062606 Tertiary Care Centers A medical facility which provides a high degree of subspecialty expertise for patients from centers where they received SECONDARY CARE. Tertiary Hospital,Tertiary Referral Center,Tertiary Referral Hospital,Care Center, Tertiary,Care Centers, Tertiary,Center, Tertiary Care,Center, Tertiary Referral,Centers, Tertiary Care,Centers, Tertiary Referral,Hospital, Tertiary,Hospital, Tertiary Referral,Hospitals, Tertiary,Hospitals, Tertiary Referral,Referral Center, Tertiary,Referral Centers, Tertiary,Referral Hospital, Tertiary,Referral Hospitals, Tertiary,Tertiary Care Center,Tertiary Hospitals,Tertiary Referral Centers,Tertiary Referral Hospitals
D018936 Hepatitis C Antigens Antigens of the virions of HEPACIVIRUS, their surface, core, or other associated antigens. Hepatitis C Antigen,Hepatitis Non-A, Non-B Antigen,Hepatitis Non A, Non B Antigen

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