Lab Med Qual Assur.  2024 Jun;46(2):96-102. 10.15263/jlmqa.2024.46.2.96.

Performance Evaluation of Hologic Panther Aptima System to Detect HBV, HCV, and HIV-1 Infections: A Comparison with Abbott Alinity m System

• Woo KS
• Kwak MS
• Han JY

• KMID: 2557224
• DOI: http://doi.org/10.15263/jlmqa.2024.46.2.96

Abstract

Background
Quantitative viral load tests are essential for diagnosing and monitoring the response to antiviral treatment for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1) infections. The Hologic Aptima Quant assay (Hologic Inc., USA) is a fully integrated and automated quantitative assay based on real-time transcription-mediated amplification technology using the Panthers system. In this study, we evaluated the performance of the Hologic Aptima Quant assay for measuring HBV, HCV, and HIV-1 viral load, and compared the results with those obtained with Abbott Alinity m system (Abbott Laboratories, USA).
Methods
The reproducibility and linearity of the assay were evaluated in the present study. Additionally, the precision, analytical specificity, interference, and limit of detection (LOD) of each assay on the Panther system were evaluated. A comparative evaluation between the Hologic Aptima Quant assay and the Abbott Alinity m assay was conducted using clinical patient samples.
Results
The results of the precision study demonstrated excellent total precision, with the coefficient of variation of precision being less than 5%. The linearity of the viral loads was excellent for all assays (correlation coefficient [R² ] >0.99 for HBV, HCV, and HIV-1). Furthermore, the specificity of all assays was determined to be 100%. The LOD results were 10 IU/mL for HBV and HCV assays, and 20 copies/mL for HIV-1 assay, with 100% replicates being detected. Additionally, the viral load measured with the Hologic Aptima Quant assay was strongly correlated with that measured with Abbott Alinity m assay (R² =0.94–0.97).
Conclusions
The Hologic Aptima Quant assay demonstrated excellent performance, with results being comparable to those obtained with the Abbott Alinity m assay for detecting HBV, HCV, and HIV-1 viral loads.

Keyword

Hepatitis B virus; Hepatitis C virus; HIV-1