Performance Evaluation of the Roche Cobas 5800 HBV and HCV Tests: Comparison of the 200 and 500 μL Protocols

다국어 초록 (Multilingual Abstract)

Background: Clinical management of patients infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) relies on the viral load (VL). The Cobas 5800 system (Roche Diagnostics) can determine VLs in 200 and 500 μL samples, but the performance of each protocol has not been compared. We evaluated the performance of both protocols for the HBV and HCV tests.
Methods: Precision and linearity were verified using commercial panels. Probit analyses were used to determine limits of detection (LoDs). The results obtained with 336 samples were compared using the 200 and 500 μL protocols. Data from 6,737 retrospective HBV and 768 HCV samples were compared to estimate the effects of the different LoDs on the diagnostic results of the protocols. Correlations between protocols were tested with Spearman’s rank correlation coefficients (rho).
Results: The precision and linearity of both protocols were verified. The LoDs for the 200 and 500 μL protocols were 6.5 and 2.7 IU/mL for HBV and 29.7 and 8.2 IU/mL for HCV, respectively. The agreement between the protocols ranged from 0.8 to 1.0. The results obtained with the HBV and HCV tests showed a strong correlation (rho=0.994). Only 0.4% of HBV and 0.4% of HCV test results were affected by the LoDs of the 200 μL protocol.
Conclusions: The Cobas 5800 200 and 500 μL protocols for the HBV DNA and HCV RNA tests demonstrated excellent performance. These findings establish the 200 μL protocol as a new option for low-volume samples, especially for pediatric and difficult-to-bleed patients.

참고문헌 (Reference)

1 Tan NK, "Verification of the Roche Cobas® 6800 PCR 200 μl and 500 μl protocols for the quantification of HIV-1 RNA, HBV DNA and HCV RNA and evaluation with COBAS® Ampliprep/COBAS® TaqMan® assays" 67 : 1711-1717, 2018

2 Sidharthan S, "Utility of hepatitis C viral load monitoring on direct-acting antiviral therapy" 60 : 1743-1751, 2015

3 Terrault NA, "Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance" 67 : 1560-1599, 2018

4 Baylis SA, "Standardization of nucleic acid tests : the approach of the World Health Organization" 57 : e01056-18-, 2019

5 Scholtès C, "Performance of the Cobas® HBV RNA automated investigational assay for the detection and quantification of circulating HBV RNA in chronic HBV patients" 150-151 : 105150-, 2022

6 Park Younhee ; Roh Juhye ; Kim Sinyoung, "Performance evaluation of the Aptima assays in comparison with the cobas 6800 Assays for the detection of HIV-1, HBV, and HCV in clinical samples" 42 : 447-456, 2022

7 Ismail AM, "Performance characteristics and comparison of Abbott and Artus real-time systems for hepatitis B virus DNA quantification" 49 : 3215-3221, 2011

8 Tschäpe J, "Multisite performance evaluation of the Cobas 5800 System and comparison to the Cobas 6800/8800 systems for quantitative measurement of HBV, HCV, and HIV-1 viral load" 10 : e0312522-, 2022

9 Caliendo AM, "Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification" 49 : 2854-2858, 2011

10 Wirden M, "Multicenter comparison of the new Cobas 6800 system with Cobas Ampliprep/Cobas TaqMan and Abbott RealTime for the quantification of HIV, HBV and HCV viral load" 96 : 49-53, 2017

11 Andersson KL, "Monitoring during and after antiviral therapy for hepatitis B" 49 (49): S166-S173, 2009

12 McHugh ML, "Interrater reliability : the kappa statistic" 22 : 276-282, 2012

13 Baylis SA, "Harmonization of nucleic acid testing for Zika virus : development of the 1st World Health Organization International Standard" 57 : 748-761, 2017

14 American Association for the Study of Liver Diseases and Infectious Diseases Society of America, "HCV guidance: recommendations for testing, managing, and treating hepatitis C"

15 World Health Organization, "Guidelines on hepatitis B and C testing"

16 European Association for the Study of the Liver, "EASL recommendations on treatment of hepatitis C 2018" 69 : 461-511, 2018

17 European Association for the Study of the Liver, "EASL clinical practice guidelines : management of chronic hepatitis B virus infection" 57 : 167-185, 2012

18 European Association for the Study of the Liver, "EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection" 67 : 370-398, 2017

19 Vermehren J, "Development of a second version of the Cobas AmpliPrep/Cobas TaqMan hepatitis C virus quantitative test with improved genotype inclusivity" 49 : 3309-3315, 2011

20 Schober P, "Correlation coefficients : appropriate use and interpretation" 126 : 1763-1768, 2018

21 한미순 ; 박용정 ; 나현진 ; 김현숙, "Comparison of the Qiagen Artus HBV QS-RGQ assay with the Roche COBAS AmpliPrep/COBAS TaqMan HBV assay for quantifying viral DNA in sera of chronic hepatitis B patients" 37 : 248-253, 2017

22 Hur Mina ; Park Mikyoung ; Moon Hee-Won ; Choe Won Hyeok ; Lee Chae Hoon, "Comparison of non-invasive clinical algorithms for liver fibrosis in patients with chronic hepatitis B to reduce the need for liver biopsy : application of enhanced liver fibrosis and Mac-2 binding protein glycosylation isomer" 42 : 249-257, 2022

23 Yeh ML, "Abbott RealTime HBV assay is more sensitive in detection of low viral load and little impacted by drug resistant mutation in chronic hepatitis B patients under nucleot(s)ide analogues therapy" 9 : e101790-, 2014

24 Terrault NA, "AASLD guidelines for treatment of chronic hepatitis B" 63 : 261-283, 2016

25 Braun P, "A European multicientre study on the comparison of HBV viral loads between VERIS HBV assay and Roche COBAS® TAQMAN® HBV test, Abbott RealTime HBV assay, Siemens VERSANT HBV assay, and Qiagen Artus HBV RG kit" 95 : 76-83, 2017