A comparative viral load evaluation for human immunodeficiency virus, hepatitis B virus and hepatitis C virus of the Roche cobas 5800, Abbott Alinity m and Hologic Panther
BACKGROUND AND OBJECTIVES: Viral load (VL) quantification for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) is essential for clinical monitoring, treatment response assessment and post-donation interpretation. With the introduction of automated molecular platforms, comparative evaluations are required to assess inter-platform agreement, bias and precision across the quantitative VL range. MATERIALS AND METHODS: A comparative study was conducted using 280 plasma samples from blood donors. VL measurements were performed using the Roche cobas 5800 system, Abbott Alinity m system and the relevant Aptima quantitative assays on the Hologic Panther system. Agreement between platforms was assessed using Deming regression, Passing-Bablok regression, Lin's concordance correlation coefficient and Bland-Altman analyses. Precision was evaluated using repeatability and reproducibility testing using coefficients of variation (CVs). Differences in mean VL measurements were assessed with one-way analysis of variance (ANOVA). RESULTS: VL and acceptable precision across all targets. Deming regression identified constant bias in comparisons and proportional bias in one HCV comparison. Passing-Bablok regression and Lin's concordance correlation coefficient further showed that agreement differed. ANOVA showed no significant differences for HBV and HCV, while HIV showed a significant difference in VL values. CONCLUSION: The platforms demonstrated acceptable precision for quantitative HIV, HBV and HCV VL testing. Roche cobas 5800 system showed low CVs in several repeatability comparisons, while within-laboratory reproducibility showed variability for HBV and HIV. Agreement analyses identified constant bias, proportional bias and variability in platform comparisons.
Authors
- Adriaan Meyer (ORCID: https://orcid.org/0000-0002-1685-9544)
- Suné Saayman (ORCID: https://orcid.org/0009-0001-6358-9946)
Institutions
- Stellenbosch University (ZA)
- South African National Blood Service (ZA)
Publication Details
- Journal
- Vox Sanguinis
- Published
- 2026-11-02
- DOI
- https://doi.org/10.1111/vox.70407
- Primary Topic
- Clinical Laboratory Practices and Quality Control
- Type
- article
- Field-Weighted Citation Impact
- 0.00