Can the nucleic acid amplification test (NAT) be an alternative to the serologic tests? A prospective study, the results of 18,200 blood donors from the Turkish Red Crescent

Kosan, Erdogan; Kocazeybek, Bekir; Altunay, Hüsnü; Aymelek, Meryem; Alan, Esra; Aslan, Mustafa; Yenen, Osman Şadi; Yüksel, Pelin; Birinci, Ilhan; Kırali, Kaan; Aksoy, Armagan

doi:10.1016/j.transci.2010.09.013

Cited by 12 publications

(10 citation statements)

References 5 publications

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“…32 serological reference test as a confirmatory test 18,20 when screening the general population for HCV infection. Our assessment of the body of evidence using GRADE methodology led us to focus on a single "least-biased" study, 26 in which the sensitivity of the ELISA version 3.0 compared with nucleic acid amplification testing was 81.8% (95% CI 59.0%-100%) and the specificity 99.7% (95% CI 99.6%-99.8%). Assuming an HCV seroprevalence rate of 0.96%, as in the general Canadian population, 2 the positive predictive value would be 72.7% (95% CI 66.2%-78.8%); in other words, 1 of every 4 positive ELISA version 3.0 test results would be a false-positive result.…”

Section: Discussionmentioning

confidence: 99%

“…22,23,26 One of the 3 studies 23 was excluded because, as a result of there being no false-negative results, the correction of the sensitivity estimate for verification bias was overly conservative 40 and the uncorrected sensitivity was too biased to be meaningful. Another study 22 was excluded because, based on its results, the study prevalence of HCV was very high, at 23.6%; this suggested that either the study population was not reflective of the general population or a case-control design was used (in either case, it did not meet our inclusion criteria).…”

Section: Assessment Of Quality Of Body Of Evidence With Grade Methodomentioning

confidence: 99%

“…Another study 22 was excluded because, based on its results, the study prevalence of HCV was very high, at 23.6%; this suggested that either the study population was not reflective of the general population or a case-control design was used (in either case, it did not meet our inclusion criteria). The quality of evidence in the remaining study 26 was assessed as very low (Table 5); this study reported a sensitivity of 81.8% (95% CI 59.0%-100%) and a specificity of 99.7% (95% CI 99.6%-99.8%). Assuming an HCV seroprevalence rate of 0.96%, as in the general Canadian population, 2 instead of the rate of 0.1% among the 17 840 blood donors in the study, 38 the positive predictive value would be 72.7% (95% CI 66.2%-78.8%), and the negative predictive value would be 99.8% (95% CI 99.8%-99.9%).…”

Section: Assessment Of Quality Of Body Of Evidence With Grade Methodomentioning

confidence: 99%

“…15,22,24,[26][27][28][29] Two studies had verification bias as a result of applying the reference test to a larger proportion of samples that had tested positive on the index test relative to those that had tested negative on the index test.…”

Section: Assessment Of Risk Of Bias With Quadas-2mentioning

confidence: 99%

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Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cadieux

Campbell

Dendukuri³

2016

CMAJ Open

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Section: Discussionmentioning

confidence: 99%

Section: Assessment Of Quality Of Body Of Evidence With Grade Methodomentioning

confidence: 99%

Section: Assessment Of Quality Of Body Of Evidence With Grade Methodomentioning

confidence: 99%

Section: Assessment Of Risk Of Bias With Quadas-2mentioning

confidence: 99%

See 2 more Smart Citations

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cadieux

Campbell

Dendukuri³

2016

CMAJ Open

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“…The safety of blood transfusion may be compromised as a result of donors that are infected with HBsAg mutants, as well as those with circulating undetectable levels of viral protein, which can escape detection by common screening tests as a result of alterations in the "a" determinant region of the S gene (Qiu et al, 2008). However, more accurate and cost-effective tests are increasingly required to prevent the risk of contracting an infection by receiving a contaminated blood unit (Kosan et al, 2010).…”

Section: Hbsag Mutation and Blood Donationmentioning

confidence: 99%

An Overview of Hepatitis B Virus Surface Antigen Mutant in the Asia Pacific

Hudu

Malik²,

Taib³

et al. 2014

Current Issues in Molecular Biology

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Hepatitis B virus infection is a serious health problem worldwide, and more than 350 million people are chronic carriers, constituting a major global threat. Southeast Asia and the Western Pacific have the highest levels of endemicity in the world, with an estimated seroprevalence ranging between 2% and 31%. Mutations in the hepatitis B surface antigen (HBsAg) have been reported in many parts of the world but are most common in Asian infants; such mutants have several clinical effects, such as the development of hepatocellular carcinoma. Diagnostic failures by commercial assays have reduced the diagnostic effectiveness of HBsAg detection. For example the substitution of an amino acid in the major hydrophilic region of the S gene reduces the binding of hepatitis B surface antibodies leading to immune escape. The safety of blood transfusion may be compromised by current screening tests due to escape from being neutralised by antibodies induced by HBsAg mutants, and undetectable levels of viral surface protein. Data on the epidemiology of HBsAg mutation in Asia Pacific are scant; however, this manuscript has reviewed the available information on the epidemiology of HBsAg mutation in Asia Pacific.

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Opportunities and challenges for the application of artificial intelligence paradigms into the management of endemic viral infections: The example of Chronic Hepatitis C Virus

Farrag,

Kamel,

El‐Baraky

2024

Reviews in Medical Virology

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Despite the advent of direct‐acting antiviral agents (DAAs) as a definitive therapy for chronic hepatitis C virus (HCV) infection, the burden of the disease remains globally elevated. The emerging big data on different HCV paradigms fostered the introduction of artificial intelligence/machine learning (AI/ML) applications to help decrease that burden by providing more optimised strategies for early diagnosis and treatment prioritisation. The current review provides descriptive and analytical insight into the recently published AI/ML applications in five medical aspects of HCV infection. In addition, it highlights the opportunities these powerful tools offer in designing national health policies that prioritise HCV patients for the costly DAAs and developing broadly neutralising HCV antibodies. Finally, this paper highlights the challenges encountered in developing and applying these AI/ML models to clinical practice and suggests schemes to overcome some of them. The presented models were primarily evaluated using the Matthews correlation coefficient and the F1‐score to make a more reliable inference about their predictive power under imbalanced datasets. Many published AI/ML applications offered great utilities for predicting novel HCV treatments and prioritising patients for DAAs receipt, especially in settings of limited resources and high HCV burden. Some outperformed the classical diagnostic tools, such as third‐generation serological tests, alpha‐fetoprotein, and ultrasound, in detecting HCV infections and early HCV‐associated hepatocellular carcinoma, respectively. However, further statistical and clinical validation of AI/ML models is highly advocated before incorporating these applications into clinical practice.

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Can the nucleic acid amplification test (NAT) be an alternative to the serologic tests? A prospective study, the results of 18,200 blood donors from the Turkish Red Crescent

Cited by 12 publications

References 5 publications

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

An Overview of Hepatitis B Virus Surface Antigen Mutant in the Asia Pacific

Opportunities and challenges for the application of artificial intelligence paradigms into the management of endemic viral infections: The example of Chronic Hepatitis C Virus

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