Akademik Veri Yönetim Sistemi
ESCV 2023, Milan, İtalya, 30 Ağustos - 02 Eylül 2023, ss.131
BACKGROUND-AIM
Hepatitis B virus (HBV) is a major global health problem affecting more than 250 million people and causing nearly one million
HBV-related human deaths annually. Plasma/serum HBV DNA load monitoring is essential to manage the disease and evaluate the
treatment response. In this study, we aimed to compare the NeuMoDx HBV Quant Assay (NMD, QIAGEN GmbH) with the artus HBV
QS-RGQ Assay (Artus, QIAGEN GmbH) using residual plasma samples and to evaluate the discordant results.
METHODS
The study included 200 patient plasma samples analyzed with the NMD assay in 2019-2020 and stored at -80°C in the Microbiology
Laboratory of Dokuz Eylül University Hospital. Samples of 100 patients containing HBV DNA (32 samples between 100-1000 IU/ml,
33 samples between 1000-10000 IU/ml, 35 samples >10000 IU/ml) and 100 HBV DNA negative samples were retrospectively
analyzed by artus in 2022. Discordant results were evaluated by cobas 6800 HBV DNA Test (Cobas, Roche Diagnostics)
RESULTS
Excellent agreement (: 0.92) was found between NMD and Artus tests. Of the 100 samples that were HBV DNA negative by NMD,
93 were negative and 7 were positive (<32 IU/ml) by Artus. All seven discordant samples were positive for HBsAg. With the Cobas
test, 5 samples were positive (<34 IU/ml), one sample was negative and one sample was invalid due to insufficient volume. Of the
100 HBV DNA positive samples detected by NMD, 99 were positive and 1 was negative with the Artus assay. This sample was also
HBV DNA negative by the Cobas test.
The difference between NMD and Artus results was ε0.5 log10 (0.55-1.65) in 23 samples. Cobas test used for discordant samples
showed a better agreement with NMD results. In 12 samples with HBV DNA >10,000 IU/mL, there was a significant difference
between HBV DNA log10 values determined by three different assays (p:0.002).
CONCLUSIONS
NMD and Artus HBV assays had comparable performance. Discordant results in quantitation were more frequent in samples with
high viral load, however would not affect patient management. The use of frozen and retested samples may be the reason for the
positive results below LLQ with Cobas and artus.