Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy


Autoři: Marcus M. Mücke aff001;  Benjamin Maasoumy aff002;  Julia Dietz aff001;  Victoria T. Mücke aff001;  Christian O. Simon aff003;  Jesse A. Canchola aff003;  Marcus Cornberg aff002;  Ed G. Marins aff003;  Michael P. Manns aff002;  Stefan Zeuzem aff001;  Heiner Wedemeyer aff002;  Christoph Sarrazin aff001;  Johannes Vermehren aff001
Působiště autorů: Department of Internal Medicine 1, University Hospital Frankfurt, Frankfurt am Main, Germany aff001;  Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany aff002;  Roche Molecular Systems, Pleasanton, CA, United States of America aff003;  Department of Gastroenterology and Hepatology, University Hospital Essen, Essen, Germany aff004;  Department of Gastroenterology, St. Josefs-Hospital, Wiesbaden, Germany aff005
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0224751

Souhrn

Background

The COBAS AmpliPrep/COBAS TaqMan assay HCV (CAP/CTM) is widely used in clinical routine for HCV testing. Recently, the new cobas HCV test was established for high throughput testing with minimal operator intervention. As different assays may yield different quantitative/qualitative results that possibly impact treatment decisions, the aim of this study was to externally evaluate the cobas HCV test performance in comparison to CAP/CTM in a clinically relevant setting.

Methods

Serum samples were obtained from 270 patients who received direct acting antiviral therapy with different treatment regimens at two study sites (Hannover and Frankfurt) in 2016. Overall, 1545 samples (baseline, on-treatment and follow-up) were tested in parallel by both assays.

Results

The mean difference between cobas HCV and CAP/CTM for the quantification of HCV RNA was 0.008 log10 IU/ml HCV RNA (95% limits of agreement: -0.02–0.036) showing excellent agreement of both assays. With respect to clinical cut offs (HCV RNA detectable vs. target not detected and HCV RNA above the lower limit of quantification (LLOQ) vs. <LLOQ), discordant results were obtained in 9.5% and 4.6%, respectively; the greatest differences were observed during early stages of antiviral therapy (week 1, week 2 and week 4), but none were statistically significant. Overall percent agreement for SVR between cobas HCV and CAP/CTM at the 15 IU/ml cutoff was 99.2% (95%CI 92.7%-100%).

Conclusion

The performance of the new cobas HCV test was comparable to CAP/CTM in a clinical setting representing a large patient population with HCV GT 1 and 3 treated with DAAs.

Klíčová slova:

Cirrhosis – Hepatitis C virus – Chronic hepatitis – Medical education – Specimen preparation and treatment – Viral load – Protease inhibitor therapy


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Článek vyšel v časopise

PLOS One


2019 Číslo 11