Evaluation of the Aptima™ HBV Quant Dx assay for semi-quantitative HBV viral load from dried blood spots.
Analysis performance
Dried blood spots
Hepatitis B virus
Resource-Limited settings
Viral load
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
30
01
2020
revised:
17
06
2020
accepted:
22
06
2020
pubmed:
7
7
2020
medline:
21
8
2021
entrez:
7
7
2020
Statut:
ppublish
Résumé
The detection and quantification of hepatitis B virus (HBV) DNA from dried blood spots (DBS) is a major tool for chronic hepatitis B management in resource-limited settings. This strategy fits in perfectly with the hepatitis control plan promoted by the World Health Organization. However, few commercial methods are validated for viral load (VL) measurement on DBS. Our objective was to evaluate the performance of the HBV VL measurement of the Aptima™ HBV Quant Dx assay on DBS compared to plasma samples on the Panther® platform (Hologic). 266 whole blood samples for routine measurement were included. Five spots of 75 μL of whole blood were loaded onto a card before centrifugation and plasma settling. 149 samples were quantifiable and 117 were not detected. We achieved excellent linearity (r² = 0.994) over a wide range of measurements suitable for clinical practice, and a 95 % lower limit of detection (LLOD-95 %) at 2.65 log The Aptima™ assay can properly detect and quantify HBV DNA in DBS, providing a satisfactory use in clinical monitoring and therapeutic decisions. DBS represents an excellent alternative to plasma, especially in resource-limited countries, while maintaining the performance and advantages of an automated technique.
Sections du résumé
BACKGROUND
The detection and quantification of hepatitis B virus (HBV) DNA from dried blood spots (DBS) is a major tool for chronic hepatitis B management in resource-limited settings. This strategy fits in perfectly with the hepatitis control plan promoted by the World Health Organization. However, few commercial methods are validated for viral load (VL) measurement on DBS.
OBJECTIVES
Our objective was to evaluate the performance of the HBV VL measurement of the Aptima™ HBV Quant Dx assay on DBS compared to plasma samples on the Panther® platform (Hologic).
STUDY DESIGN
266 whole blood samples for routine measurement were included. Five spots of 75 μL of whole blood were loaded onto a card before centrifugation and plasma settling.
RESULTS
149 samples were quantifiable and 117 were not detected. We achieved excellent linearity (r² = 0.994) over a wide range of measurements suitable for clinical practice, and a 95 % lower limit of detection (LLOD-95 %) at 2.65 log
CONCLUSION
The Aptima™ assay can properly detect and quantify HBV DNA in DBS, providing a satisfactory use in clinical monitoring and therapeutic decisions. DBS represents an excellent alternative to plasma, especially in resource-limited countries, while maintaining the performance and advantages of an automated technique.
Identifiants
pubmed: 32629186
pii: S1386-6532(20)30266-3
doi: 10.1016/j.jcv.2020.104524
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
104524Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest HLGG has received lecture fees from Hologic.