Lab Med Online.  2021 Jul;11(3):177-182. 10.47429/lmo.2021.11.3.177.

Performance Evaluation of Aptima HBV and HCV Quant Assays in the Panther System

• Choi YJ
• Kim B
• Kim Y
• Lee KA

• KMID: 2526064
• DOI: http://doi.org/10.47429/lmo.2021.11.3.177

Abstract

Background
Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections remain a serious health problem despite advancements in their prevention and treatment. Guidelines on their management recommend using viral DNA/RNA titers. Thus, accurate measurement and prompt reporting are crucial.
Methods
The performances of the Aptima HBV and HCV Quant assays (Hologic Inc., USA) were analyzed. The results were compared with those of Cobas 4800 (Roche Molecular Systems, USA). Linearity, limit of detection (LoD), and precision were evaluated as recommended in each corresponding CLSI guideline.
Results
Passing-Bablok regression analysis showed a high correlation between the two assays: regression line was y = 0.0684+1.025x (95% CI: 0.9604-1.092) for HBV and y = -0.9650+1.141x (95% CI: 1.071-1.226) for HCV. Agreement between the assays’ qualitative results based on categorical analysis was 82.30% (185/224) (κ: 0.738, 95% CI: 0.701-0.775) for HBV and 94.52% (69/73) (κ: 0.855, 95% CI: 0.796-0.914) for HCV. The LoD values for HBV and HCV were 4.448 IU/mL and 6.166 IU/mL, respectively. The percent coefficient of variation (%CV) for the HBV assay for both low and high positive controls was less than 2%, whereas for the HCV assay, %CV for low positive control was 3.20%.
Conclusions
Overall, the Aptima HBV and HCV Quant assays demonstrated a high correlation with Cobas 4800. These tests were both sensitive and precise. Therefore, we conclude that the Aptima assay is a practical tool in the management of HBV- and HCV-infected patients.

Keyword

Aptima; Cobas; Comparison; HBV; HCV; Linearity; Limit of detection; Limit of detection

Figure

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  Fig. 1 Passing-Bablok regression on 84 HBV samples quantified within the linear measuring range of both the Cobas 4800 and Aptima assays. The equation of the regression line is shown in the figure.

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  Fig. 2 Bland-Altman analysis of 84 HBV samples that quantified within the linear measuring range of both tests. The average bias (−0.19 Log IU/mL; SD=0.34 IU/mL) and the 95% confidence interval of the difference between the two tests are shown by dotted lines.

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  Fig. 3 Passing-Bablok regression on 48 HCV samples quantified within the linear measuring range of both the Cobas 4800 and Aptima assays. The equation of the regression line is shown in the figure.

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  Fig. 4 Bland-Altman analysis of 48 HCV samples that quantified within the linear measuring range of both tests. The average bias (0.19 Log IU/mL; SD=0.40 IU/mL) and the 95% confidence interval of the difference between the two tests are shown by dotted lines.

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  Fig. 5 Linearity of the Aptima HBV assay.

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  Fig. 6 Linearity of the Aptima HCV assay.

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