Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Performance Evaluation of the Roche Cobas 5800 HBV and HCV Tests: Comparison of the 200 and 500 μL Protocols

  • Seri Jeong (Department of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Su Kyung Lee (Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Eun-Jung Cho (Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Han-Sung Kim (Department of Laboratory Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Young Kyung Lee (Department of Laboratory Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Jae-Seok Kim (Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Wonkeun Song (Department of Laboratory Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Hyun Soo Kim (Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine)
  • Received : 2023.08.02
  • Accepted : 2023.11.29
  • Published : 2024.05.01
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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.

Keywords

Acknowledgement

The authors appreciate the staff at Roche Diagnostics for providing reagents and technical support. We also appreciate the Biobank at Chung-Ang University.

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