Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection

Avellón, Ana; Ala, Aftab; Díaz, Antonio Villa; Domingo, Daniel; González, Ricardo García; Hidalgo, Lorena; Kooner, Paul; Loganathan, S; Martín, Dolores; McPherson, Stuart; Muñoz-Chimeno, Milagros; Ryder, Stephen; Slapak, Gabrielle; Ryan, Pablo; Valbuena, Marta; Kennedy, Patrick

doi:10.1002/jmv.25862

Cited by 17 publications

(15 citation statements)

References 30 publications

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“…This kit detected HBs-IS at a concentration of 0.1 IU/mL and tested positive for all positive RRP specimens. These results indicated that Determine2 has equivalent sensitivity to that of automated HBsAg kits and can be used in screening for HBV infections in low-resource settings [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Performance evaluation of in vitro diagnostic kits for hepatitis B virus infection using the regional reference panel of Japan

Momose

Murayama

Yamada

et al. 2023

Virol J

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Background Hepatitis B virus (HBV) infection is a global public health concern. Precise and sensitive detection of viral markers, including HBV DNA and HBs antigen (Ag), is essential to determine HBV infection. Methods The sensitivities and specificities of 5 HBV DNA and 14 HBsAg kits were evaluated using World Health Organization International Standards (WHO IS) and the Regional Reference Panel (RRP) consisting of 64 HBsAg-negative and 80 HBsAg-positive specimens. Results All 5 HBV DNA kits detected HBV DNA in the WHO IS at a concentration of 10 IU/mL. The sensitivity and specificity to the RRP were 98.8–100% and 96.9–100%, respectively. HBV DNA titers were well correlated among the 5 kits regardless of HBV genotype. However, discordance of the HBV DNA titer was found in 5 specimens measured by CAP/CTM HBV v2.0. Among 12 automated HBsAg kits, the minimum detectable concentrations in the WHO IS varied from 0.01 to 0.1 IU/mL. Two lateral flow assays were positive for WHO IS concentrations greater than or equal to 1.0 and 0.1 IU/mL, respectively. When analyzed by the RRP, 12 automated kits exhibited a sensitivity of 98.8–100%, and 2 lateral flow assays showed sensitivities of 93.8% and 100%. The specificities of HBsAg kits were 100%. In the quantification of HBsAg, some kits showed a poor correlation of measurements with each other and showed up to a 1.7-fold difference in the regression coefficient of HBsAg titers. There were variations in the correlations of measurements among HBsAg kits when analyzed by genotype. Conclusions Five HBV DNA kits showed sufficient sensitivity and specificity to determine HBV infection. HBV DNA titers were compatible with each other irrespective of HBV genotypes. HBsAg kits had enough sensitivity and specificity to screen for HBV infection. One of the lateral flow assays had a nearly equivalent sensitivity to that of the automated HBsAg kit. HBsAg titers quantified by the evaluated kits were not compatible across the kits. Genotype-dependent amino acid variations might affect the quantification of HBsAg titers.

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Section: Discussionmentioning

confidence: 99%

Performance evaluation of in vitro diagnostic kits for hepatitis B virus infection using the regional reference panel of Japan

Momose

Murayama

Yamada

et al. 2023

Virol J

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“…A simple rapid test (Alere Determine HBsAg; Alere Medical Co. Ltd., Chiba, Japan) with a fingerstick whole-blood sensitivity and specificity of 97.2% and 98.5%, respectively, 11 was used instead of the traditional ELISA test because it is better suited for field use. Testing for HBsAg was performed according to the manufacturer's instructions.…”

Section: Methodsmentioning

confidence: 99%

Impact of hepatitis B vaccination programs in Vietnam evaluated by estimating HBsAg prevalence

Komada¹,

Ichimura²,

Shimada³

et al. 2022

Journal of Virus Eradication

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“…Importantly, point-of-care (POC) testing tools are being developed and used to more easily diagnose HBV. Through these tests, the diagnostic process can start to move away from established healthcare settings, aiding diagnosis in resource-poor locations and high-risk communities (42). Despite these advancements, hepatitis infection is still largely underdiagnosed, with approximately 80% of HBV and HBC cases remaining unidentified.…”

Section: Diagnosismentioning

confidence: 99%

Grand challenges in major tropical diseases: Part II

et al. 2023

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Tropical diseases pose a significant global health burden, particularly in developing countries. These diseases are caused by a variety of pathogens, including bacteria, viruses, protozoa, and helminths and they remain a major cause of preventable morbidity and mortality, particularly in socially vulnerable populations. The persistence of these diseases is often linked to issues such as overcrowding, lack of access to basic sanitation, inadequate health infrastructure, and uneven distribution of prevention and treatment measures despite considerable advances in these infections management. Even though the risk factors and pathogens involved may vary worldwide, in this article we will especially focus on three important groups of tropical diseases: diarrheal diseases, viral hepatitis, and arboviruses. Herein, we aim to provide an overview of the current state of research on these diseases including definitions, diagnoses, treatments, and prevention methods. We will also discuss the main grand challenges facing researchers and practitioners in this field, as well as outline potential strategies for addressing these challenges. By highlighting those topics, we hope to contribute to the ongoing efforts to control and eliminate tropical diseases. In addition, this article summarizes the priorities that are considered for publication in the journal Frontiers in Tropical Diseases, Section Major Tropical Diseases. Diarrheal diseasesDiarrheal diseases affect an estimated two billion people worldwide and cause approximately 1.57 million deaths each year (1). These diseases disproportionately affect low-income countries or marginalized populations, particularly in African and Southeast Asian regions, with limited access to health care, safe water, and sanitation (2-4). They are Frontiers in Tropical Diseases frontiersin.org 01

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Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection

Cited by 17 publications

References 30 publications

Performance evaluation of in vitro diagnostic kits for hepatitis B virus infection using the regional reference panel of Japan

Performance evaluation of in vitro diagnostic kits for hepatitis B virus infection using the regional reference panel of Japan

Impact of hepatitis B vaccination programs in Vietnam evaluated by estimating HBsAg prevalence

Grand challenges in major tropical diseases: Part II

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