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Objectives Detection of hepatitis B surface antigen (HBsAg) plays an important role in the screening and diagnosis of hepatitis B virus (HBV) infections. There is a need of highly sensitive assays with an improved lower limit of detection (LoD). Here, we evaluate the performance characteristics of the HBsAg NEXT (HBsAg new) assay in the detection of HBsAg in clinical samples.

Objectives Detection of hepatitis B surface antigen (HBsAg) plays an important role in the screening and diagnosis of hepatitis B virus (HBV) infections. There is a need of highly sensitive assays with an improved lower limit of detection (LoD). Here, we evaluate the performance characteristics of the HBsAg NEXT (HBsAg new) assay in the detection of HBsAg in clinical samples. Materials and Methods This was a cross-sectional study conducted at a tertiary care liver center in North India. The study included 439 clinical samples. The HBsAg new assay was compared to the conventional chemiluminescence-based assay (HBsAg old assay, Architect, Abbott Diagnostics, United States). The analytical sensitivity of the HBsAg new assay was evaluated by checking its performance with the second World Health Organization (WHO) international standards for HBsAg. Results Out of 439 blood samples that were retrieved from the departmental repository stored at –80°C, 100 samples were positive and 339 samples were negative for HBsAg as per the HBsAg old assay. The HBsAg new assay showed incremental detection of HBsAg in 11 additional samples. Out of these, 5 samples were confirmed as occult HBV infection and the remaining 6 were classified as "exposed-to-virus" samples (HBV core total antibody-positive). The HBsAg new assay demonstrated a high positive significant correlation with the HBsAg old assay (r = 0.881, p -value < 0.001). The HBsAg new assay could effectively detect the second WHO international standards to the level of 0.0033 IU/mL. Conclusion The HBsAg NEXT assay is a highly sensitive assay with an improved lower LoD. [ABSTRACT FROM AUTHOR]

Introduction Hepatitis B virus (HBV) infection is an endemic in many Asian countries, and among the major routes of transmission, transfusion is the one that should be prevented. Occult HBV infection (OBI) is defined as the presence of HBV DNA in the absence of detectable HBsAg, with or without anti-HBV antibodies. The aim of this study was to detect the prevalence of anti-HBc total antibodies among the HB surface antigen (HBsAg) negative individuals by way of enzyme-linked immunosorbent assay (ELISA), and detect the presence of HBV DNA among the anti-HBc seropositives by polymerase chain reaction (PCR). Anti-HBs among the HBV DNA positives were also found out by enzyme-linked fluorescent assay (ELFA). Materials and Methods A total of 910 serum samples was subjected to initial screening for HBsAg by MERILISA HBsAg ELISA kits. The anti-HB core (HBc) total antibody titer was evaluated using MONOLISA ELISA (Biorad) kits. If found negative, the samples were discarded. If found positive, the samples underwent HBV DNA testing by nested PCR. Antibody to hepatitis B surface antigen (anti-HBs) was calculated among the DNA positives by ELFA. Results A total of 133 samples were positive for anti-HBC total antibody, resulting in an overall prevalence of 14.6%. Overall prevalence of HBV DNA among the anti-HBc seropositives was 2.2%. Conclusion Among the three HBV DNA positive patients, two belonged to the preoperative screening group, which is an alarming situation. Screening of blood for HBsAg has reduced the incidence of posttransfusion hepatitis, but HBV still remains the major source of transfusion transmitted infection in India.

Introduction  Hepatitis B virus (HBV) infection is an endemic in many Asian countries, and among the major routes of transmission, transfusion is the one that should be prevented. Occult HBV infection (OBI) is defined as the presence of HBV DNA in the absence of detectable HBsAg, with or without anti-HBV antibodies. The aim of this study was to detect the prevalence of anti-HBc total antibodies among the HB surface antigen (HBsAg) negative individuals by way of enzyme-linked immunosorbent assay (ELISA), and detect the presence of HBV DNA among the anti-HBc seropositives by polymerase chain reaction (PCR). Anti-HBs among the HBV DNA positives were also found out by enzyme-linked fluorescent assay (ELFA). Materials and Methods  A total of 910 serum samples was subjected to initial screening for HBsAg by MERILISA HBsAg ELISA kits. The anti-HB core (HBc) total antibody titer was evaluated using MONOLISA ELISA (Biorad) kits. If found negative, the samples were discarded. If found positive, the samples underwent HBV DNA testing by nested PCR. Antibody to hepatitis B surface antigen (anti-HBs) was calculated among the DNA positives by ELFA. Results  A total of 133 samples were positive for anti-HBC total antibody, resulting in an overall prevalence of 14.6%. Overall prevalence of HBV DNA among the anti-HBc seropositives was 2.2%. Conclusion  Among the three HBV DNA positive patients, two belonged to the preoperative screening group, which is an alarming situation. Screening of blood for HBsAg has reduced the incidence of posttransfusion hepatitis, but HBV still remains the major source of transfusion transmitted infection in India. [ABSTRACT FROM AUTHOR]