Confirmation Of Hepatitis C Virus Infection Research Articles

Utility of hepatitis C virus core antigen testing for diagnosis and treatment monitoring in HCV infection: A study from India

PurposeThe major bottleneck in most developing countries to attain the WHO goal of eliminating hepatitis C as a public health threat by 2030 is the limited access to molecular testing and loss of infected patients to follow up. Many of the hepatitis C virus (HCV) infected patients fail to get the confirmatory HCV RNA test done after initial screening for anti-HCV antibody. The hepatitis C core antigen (HCVcAg) chemiluminescence-based assay which is newly introduced in the Indian health setup could prove to be a potential marker in the single-point screening and confirmation of HCV infection. This study was done to evaluate the performance of the HCVcAg assay for diagnosis and treatment monitoring of patients with HCV infection. MethodsIn this retrospective study 208 archived plasma samples from 184 patients were retrieved and all three markers for the laboratory diagnosis of HCV infection, anti-HCV, HCV RNA and HCVcAg were performed in a single freeze thaw cycle. For a subset of patients (n ​= ​24), paired samples, baseline samples and samples collected at 12 weeks after completion of treatment (SVR12) were available. ResultsThe sensitivity and specificity of the HCVcAg assay were 91.58% and 99.12% respectively with HCV RNA as the gold standard for the detection of active infection. There was a strong correlation between HCVcAg and HCV RNA (R ​= ​0.85, p ​< ​0•0001). Among the paired samples, the concordance between the HCVcAg and HCV RNA at baseline and at SVR12 was 95.8%. ConclusionThe HCVcAg assay showed a good correlation with the gold standard HCV RNA assay, especially in the case of treatment naïve patients. Thus, the use of HCVcAg assay as tool for testing and confirmation of HCV infection has the potential to increase the uptake of HCV testing.

Multicenter clinical evaluation of the new 3rd generation assay for detection of antibodies against hepatitis C virus on the VIDAS® system

BackgroundDetection of antibodies (anti-HCV) against hepatitis C virus (HCV) is indispensable for screening and diagnosis of viral hepatitis and for the viral safety of blood, tissue or organ donations. It gains additional importance by the new HCV drugs which improve the therapeutic possibilities dramatically. ObjectiveTo evaluate the performance of a newly developed immune assay for anti-HCV based on the well-established VIDAS platform. Study designThe assay was evaluated with samples from anti-HCV negative blood donors and from patients with or without HCV markers in six centres in France, Spain and Egypt. The status of the samples was determined by using CE-marked immune assays (Architect, AxSym, Prism, Vitros), two immunoblots (RIBA, Inno-Lia) and/or HCV RNA results. ResultsSpecificity was 99.67% in 10,320 French blood donors without anti-HCV, 99.5% in 200 anti-HCV negative hospitalized European patients and 99.0% in 198 negative patients from Egypt. Sensitivity was 99.7% in 1054 patients pretested positive by other assays; 345 patients with known genotype had genotype 1–6; 61 patients were co-infected with HIV. VIDAS was reactive in 78% of 91 patients with uncertain or very weak anti-HCV. It became on average positive at day 37 with seroconversion panels. ConclusionsThis multicentric, international study with >12,000 samples show that the new VIDAS anti-HCV assay is very suitable for screening and confirmation of HCV infection. Sensitivity, specificity and recognition of seroconversion compare favorably with well-established CE-marked tests and help to clarify discrepant results obtained with other assays.

Multiple Liver Lesions in a Patient With Positive Hepatitis C Serology and Elevated AFP: Is It HCC?

Question: A 41-year-old Tongan man presented with acute-onset right upper quadrant pain, worse with inspiration, and radiating to the right shoulder tip. He reported intermittent diarrhea over the past few months and small amounts of bright red rectal bleeding over the preceding 3 years. He had no fevers and no loss of weight. He had no significant past medical history except for pneumonia several years previously and was not taking any regular medications. He was a former smoker and drank alcohol once per month but consumed large amounts of kava (Piper methysticum). Clinical examination revealed right upper quadrant tenderness without guarding and normal chest auscultation. Laboratory analysis revealed deranged liver tests with alanine aminotransferase of 45 IU/L (normal, <40), alkaline phosphatase of 157 IU/L (normal, <120), γ-glutamyltransferase of 559 IU/L (normal, <71), and positive hepatitis C antibody enzyme immunoassay. Computed tomographic pulmonary angiography showed no evidence of pulmonary embolism, but incidentally noted multiple hypodense liver lesions, the largest lying posteriorly in the subdiaphragmatic region of liver segment VII measuring 6 cm in maximal diameter on axial sequences (Figure A). Tumor marker analysis found a significantly elevated alpha-fetoprotein (AFP) of 135,070 IU/mL (normal, <7). Subsequent multiphase computed tomography of the abdomen and pelvis confirmed multiple hypodense, nonarterially enhancing lesions within the liver. The liver did not seem to be cirrhotic and there were no signs of portal hypertension. In addition, several enlarged left mesorectal lymph nodes were noted with adjacent irregular rectal wall thickening (Figure B). What is the most likely diagnosis? What further investigations are required to confirm the diagnosis? See the Gastroenterology web site (www.gastrojournal.org) for more information on submitting your favorite image to Clinical Challenges and Images in GI. Liver lesions in patients with positive hepatitis C antibody tests should raise suspicion for hepatocellular carcinoma (HCC). However, the hepatic lesions did not fulfil imaging criteria for this diagnosis. In addition, the patient had only been tested for hepatitis C virus (HCV) antibodies and confirmation of HCV infection with hepatitis C polymerase chain reaction (PCR) testing was still awaited. The reported sensitivity and specificity of AFP for detecting HCC are 60% and 90%, respectively, at an AFP of 20 IU/mL in patients with cirrhosis.1Trevisani F. D'Intino P.E. Morselli-Labate A.M. et al.Serum alpha-fetoprotein for diagnosis of hepatocellular carcinoma in patients with chronic liver disease: influence of HBsAg and anti-HCV status.J Hepatol. 2001; 34: 570-575Abstract Full Text Full Text PDF PubMed Scopus (569) Google Scholar AFP may also be elevated in extrahepatic malignancies, including gonadal germ cell tumors and rarely in tumors of the pancreas, gallbladder, stomach, and colon. There are few case reports of AFP-producing colon carcinomas with most occurring in adult males, located in the rectum, with AFP levels of several thousand IU/mL.2Yachida S. Fukushima N. Nakanishi Y. et al.Alpha-fetoprotein-producing carcinoma of the colon: report of a case and review of the literature.Dis Colon Rectum. 2003; 46: 826-831Crossref PubMed Scopus (29) Google Scholar In view of the computed tomography findings of rectal thickening, colonoscopy was performed and revealed a polypoid, ulcerated rectal mass (Figure C). Histology confirmed poorly differentiated adenocarcinoma with positive immunostaining for AFP (Figure D). Ultrasound-guided biopsy of one of the echogenic liver lesions showed similar tumor and again was strongly positive for AFP (Figure E). The normal liver biopsy showed normal liver architecture with no evidence of fibrosis (Figure F). Confirmatory HCV recombinant immunoblot assay (RIBA) was negative and serum HCV RNA was not detected. The patient was referred for chemotherapy. This case highlights the need to confirm positive HCV enzyme immunoassays with RIBA or HCV-RNA PCR because EIAs can yield low positive predictive values among populations with a low prevalence of HCV infection.3Kamili S. Drobeniuc J. Araujo A.C. et al.Laboratory diagnostics for hepatitis C virus infection.Clin Infect Dis. 2012; 55: S43-S48Crossref PubMed Scopus (131) Google Scholar Furthermore, AFP can arise from malignancies other than HCC and histologic confirmation is recommended in patients with liver lesions that are atypical for HCC on imaging.

Diagnostic Performances of Hepatitis C Virus-NS4 Antigen in Patients with Different Liver Pathologies

Hepatitis C virus (HCV) has emerged as the major pathogen of liver disease worldwide. The aim of this study was to quantitate and evaluate the performance of HCV-NS4 antigen as an alternative approach for confirmation of viremia. Detection of HCV-NS4 was assessed in 883 patients with chronic hepatitis C. Areas under the ROC curves (AUC) were used to assess and compare diagnostic accuracy of ELISA for HCV-NS4 with quantitative HCV-RNA as a gold standard. HCV-NS4 was identified at 27 kDa using Western blot. AUC for HCV-NS4 detection was 0.95 for all patients with different liver pathologies: 0.93 for liver fibrosis (LF), 0.95 for liver cirrhosis (LC) and 0.98 for hepatocellular carcinoma (HCC). The mean ± SD (μg/mL) of HCV-NS4 in LF was 94.2 ± 55.6; in LC was 99.3 ± 64.8 and in HCC was 124.9 ± 70.3. HCV-NS4 antigen detection using ELISA is a reliable test in the confirmation of HCV infection.

Sensitivity of an anti-HCV core peptide ELISA.

A newly developed antibody assay based on a synthetic peptide of 15 amino acids derived from the core region of the hepatitis C virus (HCV) genome was evaluated in serum and plasma panels of (A) 225 haemophiliacs and (B) 44 patients with chronic non-A, non-B (NANB) hepatitis, and in (C) sequential serum samples of 9 patients with transfusion transmitted HCV infection. The new anti-core peptide ELISA was compared with the anti-C100 ELISA. For confirmation of HCV infection, samples were tested in a 4-antigen recombinant immunoblot assay (4-RIBA) and samples of panels B and C were also assayed in cDNA-polymerase chain reaction (PCR). In two panels with a high prevalence of HCV infection (88.4 and 70.5% in haemophilia and NANB hepatitis patients, respectively), the sensitivity of the anti-core peptide ELISA did not differ significantly from the sensitivity of the anti-C100 ELISA. The sensitivity of the new assay as compared with the anti-C100 assay was found to be 0.84 [95% confidence interval (CI): 0.78-0.89] versus 0.92 (95% CI: 0.87-0.95) in haemophilia patients and 0.71 (95% CI: 0.52-0.86) versus 0.84 (95% CI: 0.66-0.95) in NANB hepatitis patients. In sequential serum samples of patients with transfusion-transmitted HCV infection antibodies to the core peptide (in 6/9 patients) appeared later than antibodies to C100 (in 7/9 patients): 168 (range: 70-322) and 143 (range: 59-365) days after transfusion, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)