Anti‐HCV confirmatory testing of voluntary blood donors: comparison of the sensitivity of two immunoblot assays

Kiely, Philip; Eliades, Leo A.; Kebede, Mekonnen; Stephenson, Matthew D.; Jardine, Darren

doi:10.1046/j.1537-2995.2002.00153.x

Cited by 6 publications

(5 citation statements)

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“…Because these donors had reacted on both the 1a and 1b screening as- says as well as having immunoblot reactivity, it is likely that many represent "true" HCV antibody reactions with a single-band reactivity pattern. [19][20][21][22][23] If so, then the real BFR overlap between the two immunoassays may be considerably lower than the observed value.…”

Section: Discussionmentioning

confidence: 87%

“…Although the BFR overlap between the PRISM HCV and Abbott‐Murex assays was above the targeted 5 percent guideline set for IA2 selection, it must be noted that of 81 samples that were reactive on the IA1 and IA2, 72 were indeterminate on immunoblot. Because these donors had reacted on both the 1a and 1b screening assays as well as having immunoblot reactivity, it is likely that many represent “true” HCV antibody reactions with a single‐band reactivity pattern 19‐23 . If so, then the real BFR overlap between the two immunoassays may be considerably lower than the observed value.…”

Section: Discussionmentioning

confidence: 99%

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Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

et al. 2003

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Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

et al. 2003

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“…Thus, it is in this group of patients where more specific confirmatory tests are needed. The most widely used approach is to perform one or more immune tests combined with an immunoblot test, as this is the most cost-effective option for confirming anti-HCV carrier status in populations with a low prevalence of HCV infection [8,[10][11][12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Epidemiological, biological and histological characterization of patients with indeterminate third‐generation recombinant immunoblot assay antibody results for hepatitis C virus

Rios

Diago

Rivera

et al. 2005

Journal of Viral Hepatitis

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We studied the epidemiological, laboratory and histological characteristics of a group of patients with positive antibodies against hepatitis C virus (HCV) as determined by third-generation enzyme-linked immunosorbent assay (ELISA), and with indeterminate HCV antibody positivity as established by third-generation recombinant immunoblot assay (RIBA-3). The results obtained were compared with those recorded in a group of RIBA-3-positive patients. Both groups correspond to blood donors in whom the prevalence of hepatitis C is low. There were no statistically significant intergroup differences in mean age, or in the presence of infection risk factors. RNA positivity was much more frequent in the RIBA-positive group (71%vs 10%; P < 0.05), as was transaminase elevation during the 3 years of follow-up (54%vs 13%; P < 0.05). In 46% of the RIBA-indeterminate patients the liver biopsy proved normal, or only liver steatosis or minimal changes were detected, while 33% had persistent chronic hepatitis, and 21% showed active chronic hepatitis. A mean Knodell index score of 2.28 was recorded; 50% of the subjects showed no fibrosis, 46% grade 1 fibrosis (fibrous portal expansion), 4% grade 2 fibrosis (bridging fibrosis), and none grade 3 fibrosis (liver cirrhosis). In the RIBA-positive group, a greater percentage of patients had active chronic hepatitis, a greater Knodell index, and increased-grade fibrosis. It can be concluded that the RIBA-3-indeterminate group is epidemiologically similar to the RIBA-3-positive series, although with a lesser prevalence of laboratory test alterations, a lower viral replication index, and more likely to have benign disease - particularly in subjects without viral replication.

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“…Serological confirmation for antibodies to HIV 1 and 2, HCV and HTLV I and II is optimally achieved using an immunoblot. These use native or recombinant proteins as antigens to capture specific antibodies in the sample and, depending on the bands present, classify results as negative, indeterminate or positive . Confirmation of the presence of HBsAg is achieved by specific ‘neutralization’ assays involving incubation of the sample with anti‐HBs.…”

Section: Ttvi Testsmentioning

confidence: 99%

Screening and confirmatory testing strategies for the major transfusion‐transmissible viral infections

Seed

2014

ISBT Science Series

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Background Testing donated blood for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and human T-cell lymphotropic virus (HTLV) is important as all are transfusion-transmissible viral infections (TTVIs). A particular challenge in donor screening for TTVIs is that donor selection seeks to minimize the prevalence of TTVIs which in the context of testing substantially increases the likelihood that reactive test results represent 'false' rather than 'true' reactivity. To address this donor testing algorithms seek to combine strategies to optimize both sensitivity (optimal detection of the 'target' pathogen) and specificity (minimising 'false' reactivity)Aims First, review the fundamental principles underpinning TTVI screening and confirmatory algorithms and discuss key challenges. Second, using working examples illustrate how sound design can lead to optimal, cost-effective solutions.Materials and Methods Screening algorithms vary dependent on a number of factors including the epidemiology of the TTVI in the donor population and the available resources (e.g. funding, automation level, technical skill). TTVI screening tests include rapid tests (RT), immunoassays (IA) and nucleic acid tests (NAT). RTs and IAs target 'serological' markers of infection (anti-HIV, HIV p24 antigen, anti-HCV, HBsAg, anti-HBc or anti-HTLV) whereas NAT targets viral RNA (HCV and HIV) or DNA (HBV). NAT has the advantage of earlier detection because viral RNA/DNA appears in the bloodstream before serological markers. However NAT is comparatively expensive requiring higher levels of automation and more skilled staff. Confirmatory testing seeks to 'confirm' the presence of the pathogen of interest optimizing donor counselling and referral. The appropriate confirmatory strategy will be dependent primarily on the screening strategy and available resourcing.Results While optimal screening strategies for HIV, HCV and HBV generally include NAT for its superior ability to identify donors with early infection, there are alternative strategies which can provide almost equivalent safety. For example, the use of HIV and HCV 'combo' IAs which combine antibody with antigen (HIV p24Ag or HCV Ag) detection significantly improve sensitivity for early infection. In resource poor settings RT for HIV, HCV and to a lesser extent HBV can still provide a high level of safety particularly where carefully selected. Repeating samples reactive on a primary screening test on a second screening test (termed a 'sequential immunoassay' or SI algorithm) and assigning a final status based on concordant reactivity has been shown to improve effectiveness although is dependent on judicious test selection. For HIV, HCV and HTLV antibody based screening strategies immunoblots are often used to confirm the presence of antibody. However, immunoblots are relatively costly and can have poor specificity making it important to optimise the specificity of the screening algorithm. Immunoblotting subsequent to a sequential immunoassay approach 6 has been...

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Anti‐HCV confirmatory testing of voluntary blood donors: comparison of the sensitivity of two immunoblot assays

Abstract: Western blot and RIBA-3 showed similar sensitivity to the HCV core and NS5 proteins. However, RIBA-3 showed greater sensitivity to both NS3 and NS4 compared to the Western blot. The reduced sensitivity of the Western blot to the NS3 and NS4 proteins was observed with HCV type 3 samples.

Cited by 6 publications

References 33 publications

Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays

Epidemiological, biological and histological characterization of patients with indeterminate third‐generation recombinant immunoblot assay antibody results for hepatitis C virus

Screening and confirmatory testing strategies for the major transfusion‐transmissible viral infections

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