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నైరూప్య

Comparative Analysis of Diagnostic Performance: HAV IgG/IgM Combo Rapid Test Cassette and ELISA HAV Test

Zhang Lei, Yang Feng, Zhu Junzhe

The Hepatitis A Virus (HAV) leads to acute liver disease, Hepatitis A, predominantly is transmitted via the fecaloral route through contaminated water, food, or direct person-to-person contact. While most cases of Hepatitis A are acute with rare fatal outcomes, the disease can manifest as a mild to severe symptoms or even result in acute liver failure, which can be fatal. The World Health Organization (WHO) attributed approximately 1,300 deaths to Hepatitis A in 2019. Notably, countries with low endemicity, especially in Europe and the Americas, have recently reported a surge in Hepatitis A cases, particularly among men who have sex with men. These surges underline the importance of laboratory-based diagnostics to support public health responses during outbreaks.

Given the current epidemiological situation in many countries, there is a heightened demand for rapid, scalable diagnostic methods to optimize vaccination efforts targeting high-risk populations. Conventionally, acute Hepatitis A diagnosis relies on detecting serum anti-HAV IgM, an antibody generally present at the onset of symptoms and persisting 2-9 months post-infection. This study evaluates the performance of the HAV IgG/IgM combo rapid test cassette manufactured by Hangzhou AllTest Biotech Co., Ltd, comparing it against the ELISA method. Preliminary results affirm the product’s adherence to professional in vitro diagnostic use, underscoring its potential in expediting Hepatitis A diagnosis during outbreaks.