Evaluation of Rapid Diagnostic Tests for Assessment of Hepatitis B in Resource-Limited Settings

Abstract

Chronic Hepatitis B (HBV) is the most important cause of liver disease worldwide. There is a need for low-cost tests to aid in diagnosis and management of HBV infection in resource-limited settings. We evaluated the utility of several rapid diagnostic tests (RDT) in three different continents (Europe, South America, Africa). The HBsAg RDT showed optimal sensitivity and specificity. The anti-HBeAb RDT showed acceptable sensitivity and excellent specificity. Our results suggest that these RDTs could be used for screening and management of HBV.

Point-of-Care Tests for Hepatitis B: An Overview

“…Hepatitis B surface antibody (anti-HBs) is the key marker to determine an individual’s immunity status to hepatitis B virus and triage the need for vaccination. A few anti-HBs POCs are commercially available, but most have poor reported sensitivity ranging from 20% to 70% [ 33 , 80 , 81 , 82 ]. One study reported a sensitivity of 91.8% using an anti-HBs rapid test card among 1272 samples [ 70 ]; however, these findings require further validation.…”

“…Hepatitis E antigen (HBeAg) is a key indicator to determine phase of chronic hepatitis B infection ( Figure 2 ), treatment initiation and is used as a surrogate of HBV DNA measurement for evaluating risks of maternal-to-child-transmission [ 2 , 4 , 83 , 87 ]. Several HBeAg POCs are commercially available; however, published data show the accuracy of HBeAg POCs has a wide range, with sensitivity of 30–82% and specificity of 67–100% [ 33 , 80 , 88 ]. Similarly, Anti-HBe POCs are reported to have poor sensitivity but excellent specificity in studies [ 33 , 81 ].…”

Uji Diagnostik Virus Hepatitis B dan CRISPR-Cas Sebagai Alternatif: Sebuah Tinjauan Pustaka

“…RDT untuk HBsAg menunjukkan sensitivitas dan spesifisitas yang optimal, sedangkan RDT untuk anti-HBeAg menunjukkan sensitivitas yang masih dapat diterima dan spesifisitas yang sangat baik, sehingga dapat digunakan untuk membedakan status HBeAb. 20 Suatu studi memperlihatkan bahwa RDT tidak cukup sensitif untuk mengonfirmasi status infeksi VHB pada donor dari transfusi darah dibandingkan dengan ELISA. Untuk hasil sampel yang positif mengandung HBsAg akan terbentuk dua garis merah pada titik di daerah C dan T, yang mana garis tersebut menunjukkan reaksi antara HBsAg dengan Anti-HBsAg yang sudah dilapisi dengan konjugat koloidal.…”

Validation of Whole Blood Rapid Diagnosis Test for Hepatitis B

“…We recently published a report validating point-of-care rapid diagnostic tests (RDT) for the diagnosis of Hepatitis B virus (HBV) infection [1]. We believe that expedited and cost-effective diagnosis of HBV infection via RDT is critical to understand the epidemiology of HBV in resourcelimited settings and implement prevention and treatment strategies [2].…”