Abstract

BackgroundHepatitis B virus (HBV) infection remains a global concern with different epidemiologies due to several factors including migration, vaccination policies, and new antiviral treatment regimens. It is important to understand the characteristics of a patient population, including the prevalence of diseases, and to assess test utilization to understand and evaluate the clinical performance of laboratory tests and to improve the quality of clinical laboratories.Materials and methodsIn this study, we evaluated serologic and virologic laboratory tests including hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B envelope antigen (HBeAg), hepatitis B envelope antibody, and HBV DNA in Korean adults who were exposed to HBV.ResultsDuring the 1‐year study period, we obtained 22 750 specimens from 17 523 adult Korean patients (>18.0 years; 9894 males and 7629 females) with a median age of 50.1 years (interquartile range, 42.2‐58.2 years). Among them, five serologic and virologic laboratory tests were performed for 1340 (5.9%) specimens from 1172 adult Korean patients (>18.0 years; 647 males and 525 females) with a median age of 46.8 years (range, 19.0‐84.5 years). The prevalence of serologic and virologic tests indicating several clinical situations was evaluated. The correlation coefficient between HBV DNA and HBeAg was ρ = 0.85 (P < .0001). However, 51.9% (695/1340) of samples did not show agreement between the two test results.ConclusionsAnalysis of the prevalence of patients categorized into five serologic and virologic laboratory results would be helpful to expand our knowledge about patient population characteristics and to improve test utilization.

Highlights

  • Hepatitis B virus (HBV) infection remains a global concern with different epidemiologies due to several factors including migra‐ tion, vaccination policies, and new antiviral treatment regimens.[1]In Korea, the prevalence of HBV carriers has changed from 8‐10% in the 1980s and early 1990s to 2.9% in 2013.2 Multiple serologic and virologic tests for HBV infection are usually performed simulta‐ neously.[1,3] Hepatitis B surface antigen (HBsAg) is an envelope pro‐ tein of HBV detectable in the blood in HBV infection.[3]

  • We evaluated 22 750 specimens from 17 523 adults regarded as having chronic HBV infection during the study period

  • We evaluated results of 1340 specimens from 1172 adult Korean patients who visited private clinics and requested various HBV serologic tests and provided possible interpretation according to test result combination

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Summary

| INTRODUCTION

Hepatitis B virus (HBV) infection remains a global concern with different epidemiologies due to several factors including migra‐ tion, vaccination policies, and new antiviral treatment regimens.[1]. | 2 of 5 antibody (anti‐HBs) is an antibody to HBsAg and develops during re‐ covery from hepatitis B and in response to hepatitis B vaccination in‐ dicating past infection and immunity.[3] Hepatitis B envelope antigen (HBeAg) is a marker of viral replication indicating a highly infectious virus.[1] HBV envelope antibody (anti‐HBe) is an antibody to HBeAg detectable in persons with lower levels of HBV replication.[3] HBV DNA can be detected and quantified in serum.[1] Combinations of dif‐ ferent positive and negative results of these various tests are used for diagnosis, monitoring of HBV infection, and evaluating treatment responses.[1,4] Physicians can have difficulties in interpreting labora‐ tory results with different combination of positives and negatives when they do not understand the patient population and their result patterns.[3,5] It is important to understand the characteristics of a pa‐ tient population, including the prevalence of diseases, to understand and evaluate the clinical performance of laboratory tests, and to im‐ prove the quality of clinical laboratories.[5]. We investigated the test utilization of those HBV tests in our labora‐ tory, one of the largest referral clinical laboratories in South Korea

| MATERIALS AND METHODS
| Analytical procedures
| DISCUSSION
Findings
ETHICAL APPROVAL
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