Evaluation of a rapid on-site anti-HCV test as a screening tool for hepatitis C virus infection (original) (raw)
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Hepatitis C virus: Screening, diagnosis, and interpretation of laboratory assays
Asian Journal of Transfusion Science, 2014
An estimated 3% of the world population is infected with Hepatitis C virus (HCV), a hepatotropic RNA virus, transmitted primarily via the blood route. The major modes of transmission of the virus include injection drug use, unsafe injection practices, blood transfusion etc. HCV causes chronic hepatitis in about 80% of those infected by it. The mainstay in diagnosing infection with HCV is to initially screen high risk groups for antibodies to HCV (anti-HCV). The inclusion of serum to cutoff ratio (S/CO) in recent guidelines is helpful in deciding the supplemental assay to be used to confirm initially reactive screening results. Nucleic acid amplification tests (NAT) are used as confirmatory tools, and also to determine viral load prior to initiating treatment. Quantitative NAT has replaced qualitative assays. Genotyping is an important tool in clinical management to predict the likelihood of response and determine the optimal duration of therapy. The impact of this infection has begun to emerge in India. The problem of professional blood donation despite an existing law against it, and flourishing unsafe injection practices, are potential sources for the spread of hepatitis C in our country. All health care practitioners need to understand how to establish or exclude a diagnosis of HCV infection and to interpret the tests correctly. In the absence of a preventive or therapeutic vaccine, and also of post-exposure prophylaxis against the virus, it is imperative to diagnose infection by HCV so as to prevent hepatic insult and the ensuing complications that follow, including primary hepatocellular carcinoma (HCC). This review aims to help blood bank staff regarding options for diagnosis and management of donors positive for HCV.
A rational use of laboratory tests in the diagnosis and management of hepatitis C virus infection
Annals of hepatology
The prevalence of HCV infection is very diversified according to geographical areas and ranges from 1% in the Northern regions of the world to more than 20% as we move South. Due to the presence of HCV-associated liver diseases and the development of effective treatments, the diagnosis of HCV infection is a growing medical need. Several tests are available, from simple screening to identify the presence of anti-HCV antibodies to the more sophisticated quantification of viral load and genotyping. However, these tests are to be used in a logical, consequential and cost-effective manner. This review article will report on the protocol in use in the North-Eastern part of Italy for the screening and diagnosis of HCV infection. The protocol is based on a consensus among several experts and may be the basis for a more rational approach in this rapidly growing field.
Diagnosis of hepatitis C virus (HCV) infection and laboratory monitoring of its therapy
Journal of Clinical Virology, 2001
Background: Just after the identification and characterization of hepatitis C virus (HCV) in 1989, tests for the detection of HCV antibodies or HCV RNA in serum were developed. The enzyme-linked immunosorbent assays (ELISAs) and confirmatory/supplemental analytical antibody tests were improved in sensitivity and specificity with the development of further generations of these assays. Application of molecular tests for detecting, quantifying, and characterization of the infecting virus became very important in management of HCV infection. Objecti6es and study design: This review summarizes the assays developed for the diagnosis and management of HCV infection. Strategies for the diagnosis and monitoring with the advantages and disadvantages of the assays based on the setting and goal are discussed according to data in the literature and our experience. Results: Specific laboratory diagnostic tests for hepatitis C virus infection may be discussed under two titles: (i) Serological antibody tests which detect anti-HCV in serum or plasma; (ii) Molecular tests which detect HCV RNA genome, investigate viral load, and determine the characteristics of the genome. Strategies in different laboratory settings which screen populations with different HCV prevalences vary. Conclusions: Anti-HCV positive result in a low-risk setting such as blood banks should be confirmed with an analytical antibody test. Then a HCV RNA test should be performed on serum of the person with a positive or indeterminate confirmatory test result. On the contrary, anti-HCV positive test result in high-risk population or a situation where HCV infection is suspected, it is likely to be true positive and confirmation with HCV RNA test will be significant. Quantitative HCV RNA test and genotyping should be performed if therapy is considered.
Laboratory Diagnostics for Hepatitis C Virus Infection
Clinical Infectious Diseases, 2012
Identification of prevalent infection by hepatitis C virus (HCV) is based serologically on detecting anti-HCV immunoglobulin G, using immunoassays, immunoblot assays, and, more recently, immunochromatographybased rapid tests. None discriminate between active and resolved HCV infection. Tests for detecting HCV RNA identify active HCV infection but are costly. Serologic assays for HCV antigens have been developed and show potential for diagnosis of active HCV infection, and their performance characteristics are undergoing evaluation. The diagnosis of acute HCV infection without the demonstration of seroconversion remains elusive.
Journal of Virological Methods, 2011
The availability of a highly accurate, rapid, point-of-care test for hepatitis C virus (HCV) may be useful in addressing the problem of under-diagnosis of HCV, by increasing opportunities for testing outside of traditional clinical settings. A new HCV rapid test device (OraQuick ® HCV Rapid Antibody Test), approved recently in Europe for use with venous blood, fingerstick blood, serum, plasma, or oral fluid was evaluated in a multi-center study and performance compared to established laboratory-based tests for detection of HCV. The HCV rapid test was evaluated in prospective testing of subjects with signs and/or symptoms of hepatitis, or who were at risk for hepatitis C using all 5 specimen types. Performance was assessed relative to HCV serostatus established by laboratory methods (EIA, RIBA and PCR) approved in Europe for diagnosis of hepatitis C infection. Sensitivity to antibody in early infection was also compared to EIA in 27 seroconversion panels. In addition, the reliability of the oral fluid sample for accurate detection of anti-HCV was assessed by studying the impact of various potentially interfering conditions of oral health, use of oral care products and consumption of food and drink. In this large study of at-risk and symptomatic persons, the overall specificities of the OraQuick ® HCV Rapid Antibody Test were equivalent (99.6-99.9%) for all 5 specimen types and the 95% CIs substantially overlapped. Overall sensitivities were virtually identical for venous blood, fingerstick blood, serum and plasma (99.7-99.9%). Observed sensitivity was slightly lower for oral fluid at 98.1% though the upper CI (99.0%) was equal to the lower CI for venous blood and fingerstick blood. Most of the HCV positive subjects which gave nonreactive results in oral fluid had serological and virological results consistent with resolved infection. Sensitivity for anti-HCV in early seroconversion was virtually identical between the HCV rapid test and EIA. Detection of anti-HCV in oral fluid appeared generally robust to conditions of oral health, consumption of food and drink and use of oral care products. The OraQuick ® HCV Rapid Antibody Test demonstrated clinical performance that was equivalent to current laboratory-based EIA. This new, HCV rapid test appears suitable as an aid in the diagnosis of HCV infection and may increase testing opportunities due to its simplicity and flexibility to use multiple specimen types, including fingerstick blood and oral fluid.
The SD BIOLINE Rapid Test for Detection of Antibodies to HCV among High-Risk Patients
2015
Introduction: Hepatitis C virus (HCV) infections are a public health problem throughout the world: the World Health Organization (WHO) estimates that over 180 million people are currently infected. The aim of this study is to determine the prevalence of anti-HCV in patients at high risk of infection through using a rapid test with capillary blood and confirmation of infection by PCR testing in real time. Method: Patients were enrolled in the study from among those treated in the gastroenterology unit of the Hospital Universitario de La Samaritana. This is one of the principal referral centers in the department of Cundinamarca, but it cares for patients from across the country. Hepatitis C risk factors identified included previous history of hepatitis C, transfusions, hemodialysis, major surgery (SNC, thorax, abdomen, orthope- dic), drug addiction, tattooing, piercing, acupuncture, time in prison, experience as a sex worker, HIV/AIDS, sexually transmitted diseases, health care work, ...
Laboratory diagnosis of viral hepatitis C: The Sultan Qaboos University Hospital experience
PubMed, 2003
Objectives: A retrospective study was carried out to assess the performance of hepatitis C diagnostic assays in our laboratory, and to determine the prevalence of hepatitis C among blood donors at the Sultan Qaboos University Hospital. Methods: From 1991 to 2001, approximately 55,000 serum samples collected from blood donors and patients were submitted to our laboratory for testing. All sera were screened for antibodies to hepatitis C virus (HCV) by three successive generations of the enzyme-linked immunosorbent assay (ELISA). Anti-HCV positive sera were further tested by recombinant immunoblot assay (RIBA). Reverse-transcriptase polymerase chain reaction (RT-PCR) for HCV RNA was carried out on a limited number (241) of ELISA positive samples. Results: Out of 30012 samples from blood donors that were screened for anti-HCV, 272 (0.91%) were positive. Of these, 46.5% were confirmed positive by RIBA. The proportion of patient sera that were confirmed positive varied from 95% among intravenous drug users to 81% in patients with hepatitis to 70% in those with haemoglobinopathies. HCV RNA was detected in 67%, 6%, and 0% of the RIBA positive, indeterminate and negative samples respectively. Conclusions: Based on RIBA, the prevalence of anti-HCV among blood donors in Oman is close to 0.5%. In our experience, RIBA-positivity is predictive of HCV infection in two thirds of subjects, and HCV infection is highly unlikely in those who are RIBA-negative. The experience at SQUH with three types of HCV assays has enabled the laboratory to develop a test algorithm, starting with screening anti-HCV ELISA.
Performance of rapid hepatitis C virus antibody assays among high- and low-risk populations
Journal of Clinical Virology, 2014
Background: Rapid tests for the detection of antibodies to hepatitis C virus (anti-HCV) can facilitate access to diagnosis. Objectives: This study aimed to evaluate the performance of rapid tests for anti-HCV detection in the sera, whole blood, and oral fluid samples from individuals with different endemicity profiles and risk behaviors. Study design: Three groups donated biological samples that were tested using three anti-HCV rapid tests (WAMA, Bioeasy and OraSure): (I) suspected cases of hepatitis C, (II) individuals who were living in remote areas in Brazil and (III) crack users and beauty professionals. Reproducibility, repeatability and cross-reactivity to other infectious agents (dengue, HIV, malaria, and syphilis) were also evaluated. Results: In group I, specificities varied from 93.75% to 100% and sensitivities varied from 76.03% to 93.84% according to the EIA results. When anti-HCV/HCV RNA-reactive sera samples were considered truepositive HCV cases, the sensitivities and specificities varied from 86.3% to 99.09% and 93.75% to 100%, respectively. In group II, the OraSure rapid test presented the best performance. In group III, the Bioeasy assay performed best using saliva and whole blood and the OraSure assay performed best using oral fluid samples. The reproducibility and repeatability of the WAMA and Bioeasy tests were excellent. The level of concordance between the HCV EIAs and the rapid tests using samples that were reactive for other infectious agents varied from 82.35% to 100% for the WAMA assay and 94.11% to 100% for the Bioeasy assay. Conclusion: All of the rapid tests could be used to identify active HCV infection among individuals with different endemicity profiles and risk behaviors.
Journal of Medical Virology, 2004
A new, sensitive enzyme immunoassay has been developed for detecting and quantifying total hepatitis C virus (HCV) core antigen in anti-HCV positive or negative sera (''trak-C TM '', Ortho Clinical Diagnostics, Raritan, NJ). The purpose of this study was to evaluate the performance of trak-C as an additional laboratory diagnostic marker of viraemia. The performance was compared to HCV-RNA detection in the ''screening'' of sera from a large heterogeneous population of hospitalised patients and outpatients. Six hundred and eighteen anti-HCV negative sera, 405 anti-HCV positive/HCV-RNA negative sera, 604 anti-HCV positive/HCV-RNA positive sera and 67 anti-HCV negative sera containing antigens or antibodies potentially interfering with the performance of the assay were analysed. Supplemental HCV antibody testing was performed using a commercial strip immunoblot assay. HCV-RNA was investigated using a qualitative commercial assay. A quantitative commercial RT-PCR was used for the analysis of selected samples. Sensitivity and specificity values were 94.7 and 100%, respectively. The latter was also confirmed when anti-HCV negative samples containing potentially interfering antigens/antibodies were examined. Sensitivity below 100% was probably due to an antigenaemia below the detection limit of trak-C. Besides, because 65.6% of HCV-RNA positive/trak-C negative samples presented specific antibodies against all four RIBA antigens, the hypothesis was raised that, in some cases, the dissociation step efficiency could be sub-optimal. In conclusion, trak-C seems suitable for identifying HCV infection on large based populations. It is a rapid to perform, reliable and specific assay that can be adapted to any laboratory setting.