Performance evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus in Cameroon

Fondjo, Clavel Landry Kouam; Tagnouokam-Ngoupo, Paul Alain; Ngono, Laure; Plantier, Jean‐Christophe; Njouom, Richard

doi:10.1186/s13104-018-3465-8

Cited by 5 publications

(3 citation statements)

References 1 publication

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“…In HIV-uninfected plasma samples in this study, the performance of the 13 RDTs was high; all tests met the WHO specificity criteria and 11 of 13 met the sensitivity criteria for 1 or both lots. This is consistent with previous studies demonstrating high sensitivity and specificity of the SD Bioline [ 10 ], First Response HCV Card Test [ 14 ], and OraQuick HCV [ 9 , 10 , 15 ] in plasma samples, and high performance of a number of the RDTs in other sample types including serum and oral fluid [ 9 , 10 , 16–19 ]. In 2 systematic reviews of HCV RDTs that included studies with varying designs, references and sample types, overall pooled sensitivity was 98%–99% [ 17 , 19 ].…”

Section: Discussionsupporting

confidence: 92%

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study

Vetter

Reipold

Audu

et al. 2020

The Journal of Infectious Diseases

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Abstract Background Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies. Methods Two lots of 13 RDTs were evaluated at three laboratories using archived plasma samples from four countries (Nigeria, Georgia, Cambodia, Belgium). HCV status was determined using three reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV infected and HIV uninfected populations. Operational characteristics were also assessed. Results In total, 1,710 samples met inclusion criteria. In HIV uninfected samples (n=384), the majority of RDTs had sensitivity ≥98% in one or both lots and most RDTs had specificity ≥99%. In HIV infected samples (n=264), specificity remained high, but sensitivity was markedly lower than in HIV uninfected samples; only one RDT reached >95%. The majority of HIV infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Inter-reader variability, lot-to-lot variability and rate of invalid runs were low for all RDTs (<2%). Conclusion HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status.

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Section: Discussionsupporting

confidence: 92%

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study

Vetter

Reipold

Audu

et al. 2020

The Journal of Infectious Diseases

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“…In this study, we constructed HCV antibody basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, and commercially seroconversion panel, commercially genotype qualification panel to evaluate the performance of the HCV RDT kits. The basic panel results showed that the clinical sensitivity and clinical specificity of the seven HCV RDT kits ranged from 94% (95% CI: 83.2–98.6) to 100% (95% CI: 91.5–100), which was consistent with previous studies that the sensitivities of RDTs have varied from 90.8% to 99.9% and the specificities have varied from 92.1% to 99.9% 12,13 . The data suggest that HCV RDT kits evaluated in this study have high clinical sensitivity and clinical specificity to detect HCV infection.…”

Section: Discussionsupporting

confidence: 89%

“…Furthermore, early detection ability of RDT kit was also analysed by using HCV seroconversion panels 5,12,17 . It was found that the early detection time of A, E and G reagent was earlier than that of the reference assay, which indicated that the early detection ability of HCV RDT kit was roughly the same as that of ELISA.…”

Section: Discussionmentioning

confidence: 98%

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China

Chen

Xu³

et al. 2021

Journal of Viral Hepatitis

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Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality‐assured rapid diagnostic tests are essential to scale‐up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2–98.6) to 100% (95% CI: 91.5–100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti‐interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.

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Developments in the HCV Screening Technologies Based on the Detection of Antigens and Antibodies

Warkad

Song

Pal

et al. 2019

Sensors

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Hepatitis C virus (HCV) accounts for 15%–20% of cases of acute infection, and chronic HCV infection is developed in about 50%–80% of HCV patients. Unfortunately, due to the lack of proper medical care, difficulty in screening for HCV infection, and lack of awareness resulted in chronic HCV infection in 71 million people on a global scale, and about 399,000 deaths in 2016. It is crucial to recognize that the effective use of antiviral medicines can cure more than 95% of HCV infected people. The Global Health Sector Strategy (GHSS) aim is to reduce the new HCV infections and the HCV associated mortality by 90% and 65%, respectively. Therefore, the methods that are simple, yet powerful enough to detect HCV infections with high sensitivity, specificity, and a shorter window period are crucial to restrain the global burden of HCV healthcare. This article focuses on the technologies used for the detection of HCV in clinical specimens.

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Performance evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus in Cameroon

Cited by 5 publications

References 1 publication

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study

Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China

Developments in the HCV Screening Technologies Based on the Detection of Antigens and Antibodies

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