NDLI: Diagnosis and Monitoring of Hepatitis B Virus Infection Using the $Cobas^{®}$ HBV Test for Use on the $Cobas^{®}$ 4800 System

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Diagnosis and Monitoring of Hepatitis B Virus Infection Using the $Cobas^{®}$ HBV Test for Use on the $Cobas^{®}$ 4800 System

Content Provider	MDPI
Author	Ortonne, Valérie Wlassow, Mélanie Bouvier-Alias, Magali Melica, Giovana Poveda, Jean-Dominique Laperche, Syria Pawlotsky, Jean-Michel Chevaliez, Stephane
Copyright Year	2021
Description	(1) Background: Sensitive and accurate nucleic acid amplification technologies are now recommended for hepatitis B virus (HBV) DNA detection and quantification in clinical practice to diagnose and monitor hepatitis B infection. The aim of this study was to assess the analytical and clinical performance of the cobas® HBV Test on the cobas® 4800 System. (2) Methods: Standard panel and clinical specimens were tested in parallel with three different real-time commercial PCR assays including the cobas ® HBV Test, the Cobas® AmpliPrep/Cobas® TaqMan HBV Test v2.0 and Alinity™ m HBV assay. (3) Results: The specificity of the cobas® HBV Test was 97.9%. The limit of detection was estimated to be 2.1 IU/mL. Intra-assay and interassay coefficients of variation varied from 0.14% to 1.92% and 2.16% to 12.02%, respectively. HBV DNA levels in patients infected with different HBV genotypes strongly correlated with those measured by the two other commercial comparators assays. (4) Conclusions: The cobas® HBV Test can be confidently used to detect and accurately quantify HBV DNA in clinical practice as well as in clinical trials with the new anti-HBV drugs currently in development.
Starting Page	573
e-ISSN	20762607
DOI	10.3390/microorganisms9030573
Journal	Microorganisms
Issue Number	3
Volume Number	9
Language	English
Publisher	MDPI
Publisher Date	2021-03-11
Access Restriction	Open
Subject Keyword	Microorganisms Microbiology Hepatitis B Virus Hbv Dna Hbv Monitoring Real-time Pcr Hepatitis B Infection Diagnosis
Content Type	Text
Resource Type	Article

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