Evaluating the aptima HIV-1 quant Dx, HCV quant Dx and HBV quant assays against the Abbott HIV-1, HCV and HBV RealTime assays

Copyright © 2018 Elsevier B.V. All rights reserved..

BACKGROUND: Viral load measurement is routine for the management of patients infected with HIV, HCV or HBV, using sensitive, quantitative, nucleic acid amplification tests (NAATs). However, platforms are not equivalent in terms of turnaround time, random access capability and operator hands-on time.

OBJECTIVES AND STUDY DESIGN: We compared the performance of the Hologic Panther transcription-mediated amplification based Aptima assays for HIV, HBV and HCV viral load measurement with the corresponding Abbott m2000 RealTime assays. All Aptima assays were run according to the manufacturer's instructions, on archived patient samples for HIV (n = 251 including subtypes 01_AE, A (A1), B, BG recombinant, C CRF02_AG and G), HBV (n = 117 including genotypes A, B, C and D) and HCV (n = 82 including genotypes 1, 2, 3 and 4). Additional testing was performed with WHO international standards and expanded HIV-1 subtype and HCV NIBSC genotype panels.

RESULTS: The Hologic Panther Aptima assays for HIV-1 RNA, HBV DNA and HCV RNA viral load measurements performed equivalently to the Abbott m2000 RealTime assays. The performance of the Aptima assays was also acceptable on the WHO and NIBSC standards and subtype/genotype panels.

CONCLUSIONS: The Aptima Panther platform offers equivalent clinical performance for the viral load measurement of these three viruses, with the added benefits of reduced turnaround time, random access capability and reduced 'hands-on time' for staff, resulting in a potentially superior workflow for diagnostic laboratories.

Medienart:

E-Artikel

Erscheinungsjahr:

2018

Erschienen:

2018

Enthalten in:

Zur Gesamtaufnahme - volume:106

Enthalten in:

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 106(2018) vom: 10. Sept., Seite 7-10

Sprache:

Englisch

Beteiligte Personen:

May, Shoshanna [VerfasserIn]
Adamska, Ewelina [VerfasserIn]
Tang, J W [VerfasserIn]

Links:

Volltext

Themen:

Comparative Study
Evaluation Study
Journal Article
Reagent Kits, Diagnostic

Anmerkungen:

Date Completed 29.04.2019

Date Revised 10.12.2019

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1016/j.jcv.2018.06.015

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM286480654