scholarly journals Performance of a New-Generation Chemiluminescent Assay for Hepatitis B Surface Antigen

2006 ◽  
Vol 52 (8) ◽  
pp. 1592-1598 ◽  
Author(s):  
Dan Chen ◽  
Lawrence A Kaplan
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
False Negative ◽  
Negative Results ◽  
False Negative Results ◽  
Serologic Markers ◽  
Hbsag Assay ◽  
New Generation ◽  
Dna Pcr

Abstract Background: The usual criteria for analysis of hepatitis B surface antigen (HBsAg) are detection of HBsAg and result confirmation by antibody neutralization. We observed that with the Immulite 2000 HBsAg assay [Diagnostics Product Corporation (DPC)] a relatively high percentage of weakly reactive (WR) samples did not pass the neutralization step. Methods: For each of 3 lots of Immulite 2000 HBsAg reagent (DPC), we collected and analyzed HBsAg data from ∼3000 to 4000 patient blood samples and compared these data with HBsAg data from 3393 samples tested with the Abbott Auszyme assay. For 127 samples with initially WR detection signals (relative signal/cutoff index of 1.00–2.5) on the Immulite 2000 HBsAg assay, we then measured hepatitis B (HB) viral load and/or other HB serologic markers. Results: The Immulite 2000 HBsAg assay produced more initially reactive results than the Abbott Auszyme method. Many of these reactive samples, however, were WR and did not meet the confirmation criteria in the neutralization test. Moreover, DNA PCR testing indicated that 22 of the 38 WR samples (58%) that did meet the confirmation criteria had no detectable HB viral DNA. Conclusions: Immulite 2000 HBsAg assay results include a unique group of WR samples that are associated with both false-positive and false-negative results, regardless of neutralization status, and require careful interpretation. WR HBsAg samples should be reported as confirmed HBsAg reactive only if the samples not only meet the neutralization criteria but also are positive for other HB serologic markers such as anti-HB core total and anti-HB core IgM.

Need for Confirmatory Neutralization Tests for Hepatitis B Surface Antigen Tests in Populations with Intermediate Prevalence

2021 ◽  
Author(s):  
Min Young Lee ◽  
So Young Kang ◽  
Woo In Lee ◽  
Myeong Hee Kim
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Neutralization Test ◽  
Hepatitis B Surface Antigen ◽  
False Negative ◽  
Confirmatory Test ◽  
Negative Group ◽  
Positive Group ◽  
Test Kit ◽  
Antigen Tests

Abstract Objective Hepatitis B surface antigen (HBsAg) is known as the hallmark of hepatitis B virus (HBV) infection. This study aimed to determine whether an HBsAg neutralization test is necessary to accurately interpret HBsAg test results. Methods Initially reactive HBsAg specimens from a 5-year period, with cutoff index values between 1.0 and 2.0, were subjected to neutralization confirmatory testing using an Elecsys HBsAg Confirmatory test kit (Roche Diagnostics GmbH. Mannheim, Germany). Results The neutralization test showed 46.1% positive (confirmed positive group) and 53.9% negative (confirmed negative group) results from the total specimens. Among the confirmed negative group, 79.5% of patients were confirmed to be negative for the current infection, whereas 4 patients in the chronic hepatitis B subgroup showed a neutralization percentage close to 40%. More than half of patients in the confirmed positive group were considered to be in the hepatitis B e antigen-negative inactive HBsAg carrier phase. Conclusion In populations with intermediate HBV prevalence, a neutralization test is necessary to confirm an HBsAg result and reduce the false positive and false negative rates of initial HBsAg tests.

scholarly journals Notes from the Field: False-Negative Hepatitis B Surface Antigen Test Results in a Hemodialysis Patient — Nebraska, 2017

2018 ◽  
Vol 67 (10) ◽  
pp. 311-312 ◽  
Author(s):  
Blake Hendrickson ◽  
Saleem Kamili ◽  
Tim Timmons ◽  
Peter C. Iwen ◽  
Caitlin Pedati ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hemodialysis Patient ◽  
Hepatitis B Surface Antigen ◽  
False Negative ◽  
Test Results ◽  
Antigen Test

scholarly journals False-Negative Hepatitis B Virus (HBV) Surface Antigen in a Vaccinated Dialysis Patient with a High Level of HBV DNA in the United States

2012 ◽  
Vol 19 (5) ◽  
pp. 820-822 ◽  
Author(s):  
Matthew C. Foy ◽  
Chloe L. Thio ◽  
Hyon S. Hwang ◽  
Melissa Saulynas ◽  
James P. Hamilton ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Surface Antigen ◽  
Hemodialysis Patient ◽  
Hepatitis B Surface Antigen ◽  
False Negative ◽  
The United States ◽  
Hbv Dna ◽  
B Virus ◽  
High Level

ABSTRACTScreening with hepatitis B surface antigen (HBsAg) is highly recommended for at-risk individuals. Mutations in the HBsAg can result in an inability to detect the virus during routine screening. We describe a hemodialysis patient found to have high levels of hepatitis B virus (HBV) DNA and HBV antibody but negative HBsAg on two routine assays.

scholarly journals Prevalence of HBV/HCV Infections in HIV-Positive Patients in Northern Iran

2018 ◽  
Vol 5 (4) ◽  
pp. 61
Author(s):  
Mehrnaz Bakhti ◽  
Mohammadreza Haghshenas ◽  
Reza Valadan ◽  
Mehdi Rabie Rudsari
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Demographic Data ◽  
Treatment Programs ◽  
Hiv Positive ◽  
Northern Iran ◽  
Negative Results ◽  
The North ◽  
Hcv Antibody

Introduction: Human immunodeficiency virus (HIV) infection increases the risk of infection with other pathogens, including hepatitis B virus (HBV) and hepatitis C virus (HCV). A crucial aspect of HIV prevention and treatment programs is knowledge of the prevalence of co-infection of HIV and HBV and/or HCV. This study sought to determine HBV and HCV co-infection in HIV-positive patients in northern Iran. Materials and Methods: Blood samples were collected from 83 HIV-positive patients whose infection was previously confirmed by real-time polymerase chain reaction in the HIV center in the North of Iran. A structured questionnaire was used to obtain socio-demographic data from participants. Samples were screened for hepatitis B surface antigen and anti-HCV antibody. All non-reactive samples were recorded as negative. Results: The 83 patients comprised 50 (60%) males and 33 (40%) females. Twenty eight (33%) and 15 (18%) subjects were positive for HCV antibody and hepatitis B surface antigen, respectively. Seven (8%) of subjects were co-infected with all three viruses. Conclusion: Seroprevalence of HCV and HIV co-infection was high and was strongly related to mutual acquisition. 

scholarly journals Clinical usefulness of a newly developed high-sensitive hepatitis B surface antigen (HBsAg) assay for monitoring hepatitis B reactivation

Kanzo ◽  
2019 ◽  
Vol 60 (7) ◽  
pp. 237-247 ◽  
Author(s):  
Kumiko Oone ◽  
Takako Inoue ◽  
Shigeru Kusumoto ◽  
Tomoyuki Ohike ◽  
Takaaki Goto ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Clinical Usefulness ◽  
Hepatitis B Reactivation ◽  
Hbsag Assay
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