Accessible Unlicensed Requires Authentication Published by De Gruyter August 18, 2015

Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma

Gunnar Schalasta, Anna Börner, Andrea Speicher and Martin Enders

Abstract

Background: Quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma has become the standard of care in the management of HIV-infected patients. There are several commercially available assays that have been implemented for the detection of HIV-1 RNA in plasma. Here, the new Hologic Aptima® HIV-1 Quant Dx assay (Aptima HIV) was compared to the Roche COBAS® TaqMan® HIV-1 Test v2.0 for use with the High Pure System (HPS/CTM).

Methods: The performance characteristics of the assays were assessed using commercially available HIV reference panels, dilution of the WHO 3rd International HIV-1 RNA International Standard (WHO-IS) and plasma from clinical specimens. Assay performance was determined by linear regression, Deming correlation analysis and Bland-Altman analysis.

Results: Testing of HIV-1 reference panels revealed excellent agreement. The 61 clinical specimens quantified in both assays were linearly associated and strongly correlated.

Conclusions: The Aptima HIV assay offers performance comparable to that of the HPS/CTM assay and, as it is run on a fully automated platform, a significantly improved workflow.


Corresponding author: Gunnar Schalasta, Prof. Gisela Enders and Kollegen MVZ Rosenbergstr. 85, 70193 Stuttgart, Germany, Phone: +49 7116357140, E-mail:

Acknowledgments

This study was supported by Hologic Inc., San Diego, CA. We offer special thanks to the members of the Molecular Biology Department of the Laboratory Prof. Enders in Stuttgart, Germany for excellent technical assistance.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2015-6-5
Accepted: 2015-7-22
Published Online: 2015-8-18
Published in Print: 2016-3-1

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