Lateral Flow Assay for Hepatitis B Detection: A Review of Current and New Assays

Abstract

From acute to chronic hepatitis, cirrhosis, and hepatocellular cancer, hepatitis B infection causes a broad spectrum of liver diseases. Molecular and serological tests have been used to diagnose hepatitis B-related illnesses. Due to technology limitations, it is challenging to identify hepatitis B infection cases at an early stage, particularly in a low- and middle-income country with constrained resources. Generally, the gold-standard methods to detect hepatitis B virus (HBV) infection requires dedicated personnel, bulky, expensive equipment and reagents, and long processing times which delay the diagnosis of HBV. Thus, lateral flow assay (LFA), which is inexpensive, straightforward, portable, and operates reliably, has dominated point-of-care diagnostics. LFA consists of four parts: a sample pad where samples are dropped; a conjugate pad where labeled tags and biomarker components are combined; a nitrocellulose membrane with test and control lines for target DNA-probe DNA hybridization or antigen-antibody interaction; and a wicking pad where waste is stored. By modifying the pre-treatment during the sample preparation process or enhancing the signal of the biomarker probes on the membrane pad, the accuracy of the LFA for qualitative and quantitative analysis can be improved. In this review, we assembled the most recent developments in LFA technologies for the progress of hepatitis B infection detection. Prospects for ongoing development in this area are also covered.

Performance Evaluation of Determine HBsAg 2 Rapid Card Test for the Detection of Hepatitis B Surface Antigen in Clinical Samples

“…Accurate, reliable, and affordable POC assays are needed for mass testing of the general public. Currently, in-use Rapid HBsAg card tests show good clinical sensitivity and specificity 5 , 8 but show low accuracy due to poor analytical sensitivity (2–10 IU/mL). 5 , 6 This leads to “missed” HBV cases and increased transmission rates.…”

“…Currently, in-use Rapid HBsAg card tests show good clinical sensitivity and specificity 5 , 8 but show low accuracy due to poor analytical sensitivity (2–10 IU/mL). 5 , 6 This leads to “missed” HBV cases and increased transmission rates. HBV can remain “silent” inside the liver for years and with increasing age, may cause liver-related complications, leading to decreased quality of life and healthcare costs.…”

“… 4 Rapid diagnostic testing is an effective method to screen large communities cost-effectively. 5 Despite the availability of effective vaccines and advancements in HBV diagnosis and treatment strategies, early access to testing is still a hurdle in low and middle-income countries. Although the routinely used enzyme-based immunoassays (EIA) for HBsAg detection have good sensitivity and specificity, 6 the requirement of dedicated lab infrastructure, trained personnel and high cost limits its use in resource-limited settings.…”