NeuMoDx random access molecular diagnostic system for detection and quantification of hepatitis B virus in clinical samples.

Ayse Arikan,Murat Sayan,Osman Doluca

doi:10.3855/jidc.12659

Abstract

Currently, several molecular assays are available to detect and quantify HBV DNA in clinical samples. We aimed to characterize and compare the clinical performance of newly designed NeuMoDx PCR to the existing artus PCR. The plasma HBV DNA levels of 96 clinical and 5 external quality control samples were measured by NeuMoDx and artus assays simultaneously in Kocaeli University, Turkey. The linearity, agreement and the correlation between two assays were determined by Deming regression analysis, Bland-Altman plotting, the chi-square and the relative absolute error statistical analyzes. For all statistical analyzes, the XLSTAT statistical program was used. The mean (standard deviation; SD) age was 45.07 ± 12.29. HBsAg S/Co median (range) was 4,273.4 ± 1,138.1 and ALT U/L median (range) was 27 ± 16. The mean (SD) of HBV DNA was 1.46+E6 ± 1.0+E4 for NeuMoDx and 1.54+E5 ± 4.7 + E4 for artus assays. The Deming regression indicates a linear correlation (95% confidence). The chi-square test indicates strong correlation (p < 0.001). Bland-Altman analysis confirms that the measurement difference is acceptable. The relative absolute error analysis for artus showed relatively less and more consistent error rate. With 5 external quality check samples, the statistical significance was low (p = 0.566). The NeuMoDx HBV assay showed an excellent analytical performance by providing a rapid, high throughput technology in a random-access testing system in clinical samples and may be a new solution for viral load quantification in the management of HBV infections.

Highlights

Several molecular assays are available to detect and quantify hepatitis B virus (HBV) DNA in clinical samples
According to the World Health Organization (WHO), an estimated 257 million people were living with chronic hepatitis B (CHB) infection globally and approximately 1.34 million deaths, mostly associated with cirrhosis and hepatocellular carcinoma (HCC) was reported
The obtained viral loads in IU/mL were converted into log IU/mL values to be used in the correlation analysis between NeuMoDx and artus HBV assays

Summary

Introduction

Several molecular assays are available to detect and quantify HBV DNA in clinical samples. Methodology: The plasma HBV DNA levels of 96 clinical and 5 external quality control samples were measured by NeuMoDx and artus assays simultaneously in Kocaeli University, Turkey. The linearity, agreement and the correlation between two assays were determined by Deming regression analysis, Bland-Altman plotting, the chi-square and the relative absolute error statistical analyzes. The mean (SD) of HBV DNA was 1.46+E6 ± 1.0+E4 for NeuMoDx and 1.54+E5 ± 4.7 + E4 for artus assays. Conclusions: The NeuMoDx HBV assay showed an excellent analytical performance by providing a rapid, high throughput technology in a random-access testing system in clinical samples and may be a new solution for viral load quantification in the management of HBV infections. The infection may progress as clearance of HBV, acute infection or chronic hepatitis B infection resulting organ failure and hepatocellular carcinoma (HCC). Early detection enables an opportunity to identify those at risk of progression, reduce complications of liver cirrhosis and liver cancer, and reduce the risk of transmission of the virus to others

Objectives

Methods

Results

Conclusion