Clinical Performance Evaluation of the Aptima Viral Assays for the Quantitation of HIV-1, HCV, and HBV in Plasma Samples

Elsevier

Available online 5 April 2023, 115951

Diagnostic Microbiology and Infectious DiseaseAuthor links open overlay panel, , , ABSTRACT

The clinical performance of the Aptima® HIV-1 Quant Dx, Aptima HCV Quant Dx, and Aptima HBV Quant Dx were evaluated and compared to the Roche cobas HIV-1, HCV, and HBV assays performed on the Roche cobas 6800 system. The Aptima Quant assays exhibited an overall percent agreement of 99.4% for HBV, 98.3% for HCV, and 85.14% for HIV-1. The average log difference between the Aptima and Roche assays was below 0.2 IU/mL and the quantitative correlation's (R-squared value (R2)) was between 0.95 and 0.97. The Aptima viral assays demonstrated a high level of quantitative correlation with the Roche cobas assays for HCV, HBV, and HIV-1.

Key Words

HIV-1, HCV, HBV

viral load

Aptima

cobas

© 2023 The Author(s). Published by Elsevier Inc.

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