Development and genomic characterization of a diverse HIV-1 variant reference panel for nucleic acid-based testing.

Jiangqin Zhao¹, Tianxiong Li², Hanxia Huang², Venice Servellita³, Alicia Sotomayor-Gonzalez³, Oksana Yakovleva², Xue Wang², Viswanath Ragupathy², Santanu Biswas², Patricia Barilko⁴, Ethan Sun⁴, Samantha Huynh⁴, Melissa Hunsicker⁵, Jessica DeQuach⁵, Jose D Morales⁵, Helene Highbarger⁶, Robin L Dewar⁶, Cassie Porth⁷, Thomas N Denny⁸, David R McGivern⁹, Charles Y Chiu³, Indira Hewlett²

¹Laboratory of Molecular Virology, DETTD, OBRR, CBER, FDA, 10903 New Hampshire Ave, Silver Spring, MD, United States. Electronic address: Jiangqin.Zhao@fda.hhs.gov.

²Laboratory of Molecular Virology, DETTD, OBRR, CBER, FDA, 10903 New Hampshire Ave, Silver Spring, MD, United States.

³Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, United States.

⁴Roche Diagnostics Solutions, Clinical Development and Medical Affairs (CDMA), Pleasanton, CA, United States.

⁵Hologic, Inc., San Diego, CA, United States.

⁶Virus Isolation and Serology Laboratory (VISL), Frederick National Laboratory, Frederick, MD, United States.

⁷EQAPOL, Duke University, Durham, NC, United States. Electronic address: Cassandra.Porth@duke.edu.

⁸EQAPOL, Duke University, Durham, NC, United States.

⁹Laboratory of Molecular Virology, DETTD, OBRR, CBER, FDA, 10903 New Hampshire Ave, Silver Spring, MD, United States. Electronic address: David.McGivern@fda.hhs.gov.

PubMed PMC DOI PDF

Abstract

BACKGROUND: The high worldwide genetic diversity of HIV poses significant challenges for its detection and diagnosis by nucleic acid testing (NAT). Well-characterized reference panels are important for evaluating the analytical performance of HIV tests. OBJECTIVE: To develop a reference panel for HIV NAT that reflects the genetic diversity of circulating strains. STUDY DESIGN: HIV was cultured f…

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