COMPARISON OF THE NEUMODX® AND ARTUS HBV QS-RGQ® ASSAYS FOR THE QUANTIFICATION HBV DNA IN CLINICAL SAMPLES


Appak Ö., Sayıner A. A.

ESCV 2023, Milan, Italy, 30 August - 02 September 2023, pp.131

  • Publication Type: Conference Paper / Summary Text
  • City: Milan
  • Country: Italy
  • Page Numbers: pp.131
  • Dokuz Eylül University Affiliated: Yes

Abstract

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.