Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0 (original) (raw)
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Journal of gastrointestinal and liver diseases : JGLD, 2014
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. 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. 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%)...
Viral Hepatitis Journal
Objectives: Recently, with the use of direct-acting antivirals (DAA) for treating chronic hepatitis C (CHC), the success rate has exceeded 90%. The implementation of these strong therapies has reduced the role of monitoring therapy with hepatitis C virus (HCV)-RNA tests. The current study compares the HCV-core antigen test (HCV-Ag) with HCV-RNA in terms of correlation, effectiveness and cost in patients who started DAA and to evaluate the usability of HCV-Ag as a routine laboratory test. Materials and Methods: This study includes 76 patients with CHC. Patients with positive HCV-RNA, over 18 years old and who will initiate DAA are included. HCV-Ag level was studied in all samples by using ARCHITECT core antigen measurement Abbott method. HCV-RNA and anti-HCV levels compared with HCV-Ag levels. Results: Of the 76 patients, 44 (57%) were males, 48 (63%) were treatment experienced and 21 (27%) were cirrhotic. All patients were started with DAAs. When compared before and after treatment, HCV-RNA level, HCV-Ag level was found to be significantly different (p<0.001). Before treatment, HCV-RNA and HCV-Ag levels were found to be positive correlations (correlation coefficient: 0.419). Conclusion: The use of DAAs in HCV therapy has eliminated the need for response-guided therapy. It has been demonstrated in the study that HCV-Ag measurement is very successful and cost effective in detecting viremic patients and evaluating virological response, which are the two most important factors in the management of CHC.
Quantitative Determination of Hepatitis C Core Antigen in Therapy Monitoring for Chronic Hepatitis C
Intervirology, 2011
The correlation and kinetics of hepatitis C virus (HCV) RNA and HCV core antigen levels in chronic hepatitis C patients treated with pegylated interferon + ribavirin were evaluated in order to envision a combined use of the two assays in therapy monitoring. HCV core antigen levels by a chemiluminescent immunoassay (Abbott ARCHITECT) and HCV-RNA levels by branched DNA (bDNA) or real-time PCR have been evaluated on plasma specimens from 32 patients treated for chronic hepatitis C. An early virological response (undetectable levels of HCV-RNA 4 weeks after start of treatment) was found in 10/23 subjects (43.5%) followed up for 5 months or more. The response was linked to the HCV genotype (20% in genotype 1B vs. 61.5% in other genotypes; p < 0.05). HCV RNA and HCV antigen showed a good correlation (r = 0.814); HCV antigen was still detectable in 3 samples with undetectable (<615 IU/ml) RNA by bDNA, while no differences in clinical sensitivity were recorded in comparison with real-...
in Vivo, 2023
Background/Aim: Hepatitis C virus (HCV) core antigen (Ag) test has been increasingly applied as an effective alternative to conventional molecular tests allowing rapid and affordable diagnosis, which is of paramount relevance to achieve global elimination of HCV infection. Materials and Methods: ARCHITECT ® HCV Ag test was evaluated in comparison with HCV RNA quantification test (CAP/CTM) to calculate its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and to determine their correlation level. Its performance, according to low and high viral load values and in different treatment stages [during treatment (T), at the end of the therapeutic protocol (EOT) and when sustained virological response (SVR) was evaluated]. Results: In total, 145 samples were included. Considering CAP/CTM, the sensitivity, specificity, PPV and NPV of the HCV-Ag test were 88.9%, 99.1%, 97.0% and 96.4%, respectively, and the correlation among tests was high (r=0.890), with only five discordant results. A decrease in sensitivity was found for low viral load values (<1,000 IU/ml), but the opposite was verified for high viral concentrations (≥1,000 IU/ml). A good agreement was verified for the T and EOT groups (k=0.789 and k=0.638) and an excellent agreement in the SVR group (k=1.000). Conclusion: HCV-Ag seems to be an effective alternative that can be routinely combined with other faster and more accessible tests (e.g., HCV antibody tests) for the identification of new HCV infections in suspected patients, eventually reserving the molecular techniques for samples with discordant results.
Antiviral therapy, 2016
The introduction of highly potent direct acting combination therapies for Hepatitis C (HCV) have negated the role of response guided therapy and reduced the role of treatment monitoring. However there remains a need to identify patients who are actively infected with HCV and discriminate those who have achieved Sustained Virologic Response (SVR) from those who fail to achieve SVR. 1678 plasma samples from the 631 subjects enrolled in AbbVie's Sapphire I trial (#NCT01716585) were tested in a blinded fashion with Abbott HCV core antigen (cAg) assay and results were compared with Roche High-Pure/COBAS® TaqMan HCV RNA 2.0 assay RESULTS: Using 10 fMol/mL clinical cutoff the HCV RNA and cAg tests were in 100% agreement for true negative samples and 99.6% agreement for truly positive samples. One discordant (screening) sample was identified. This sample was Target Not Detected by HCV RNA method but positive by Anti-HCV and highly positive by cAg (7912 fMol/mL). Seventeen samples had cA...
Egyptian Journal of Medical Microbiology
Background: Chronic HCV infection and the associated complications represent a significant threat to the medical community particularly in highly endemic areas. HCV core antigen (HCVcAg) in serum or plasma is a marker of HCV replication and viral kinetics. HCVcAg becomes detectable few days after HCV RNA and can be used as a substitute for HCV RNA for the diagnosis of acute or chronic HCV infection. Objective: The objective of this study was to correlate between serum levels of HCVcAg and liver enzymes (surrogate markers of liver damage) for assessment of disease activity in chronic HCV-infected patients among Egyptians. Methodology: This study involved 28 patients (10 females & 18 males) from those attending the Outpatient Clinic of Shebin El-Kom Fever Hospital with chronic HCV infection. They were classified according to Child Pugh classification into Child-Pugh stage A (71.4%) and stage B (28.6%). All patients were subjected to full history taking, clinical examination, abdominal ultrasound, liver function tests, renal function tests, CBC, fasting blood sugar and measurement of serum HCVcAg level by enzyme linked immunosorbent assay (ELISA). Results: Serum levels of ALT as well as AST were significantly elevated in liver cirrhotic patients. There was a highly significant positive correlation between HCVcAg and ALT, AST, GGT and ALP (P-value <0.001) while there was no statistically significant correlation between HCVcAg and total bilirubin, albumin, AFP levels, PT time, PT concentration and INR (P-value > 0.05).Conclusion: HCVcAg concentrations had an excellent correlation with liver enzymes levels. HCVcAg could be believed as prognostic marker for disease severity in chronic HCV infection.