A comparative viral load evaluation for human immunodeficiency virus, hepatitis
B
virus and hepatitis
C
virus of the Roche cobas 5800, Abbott Alinit
Adriaan Meyer, Suné Saayman Abstract
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
The platforms showed comparable log 10 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.