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

  • Ayse Arikan Department of Medical Microbiology and Clinical Microbiology, Faculty of Medicine, Near East University, Nicosia, Northern Cyprus
  • Murat Sayan PCR Unit, Educational and Research Hospital of Kocaeli, Kocaeli University, Kocaeli, Turkey
  • Osman Doluca Department of Biomedical Engineering, Izmir University of Economics, Izmir, Turkey
Keywords: Chronic hepatitis B, hepatitis B virus, viral load, polymerase chain reaction, plasma, regression analysis, Chi-Square test

Abstract

Introduction: 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.

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. For all statistical analyzes, the XLSTAT statistical program was used.

Results: 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).

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.

Published
2020-10-31
How to Cite
1.
Arikan A, Sayan M, Doluca O (2020) NeuMoDx random access molecular diagnostic system for detection and quantification of hepatitis B virus in clinical samples. J Infect Dev Ctries 14:1197-1203. doi: 10.3855/jidc.12659
Section
Original Articles