External Quality Assessment Program for Next-Generation Sequencing-Based HIV Drug Resistance Testing: Logistical Considerations

• Published in: Viruses Vol. 12; no. 5; p. 556
• Main Authors: Ji, Hezhao, Parkin, Neil, Gao, Feng, Denny, Thomas, Jennings, Cheryl, Sandstrom, Paul, Kantor, Rami
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 18.05.2020; MDPI
• Subjects: Bioinformatics; Clinical trials; Congresses as Topic; Diagnostic Tests, Routine - standards; DNA sequencing; Drug resistance; Drug Resistance, Viral - genetics; Drug therapy; Evaluation; external quality assessment; Forecasts and trends; Genotype; Genotyping; High-Throughput Nucleotide Sequencing - standards; HIV; HIV Infections - virology; HIV-1 - genetics; Human immunodeficiency virus; Medical laboratories; Methods; Next-generation sequencing; Opinion; Quality; Quality Assurance, Health Care - organization & administration; Quality control; R&D; Regulatory agencies; Research & development; Sequence Analysis, RNA - standards; Testing; Viral reagents; Virology; Canada; United States > US; Asia; drug resistance; external quality assessment; HIV; next generation sequencing
• ISSN: 1999-4915; 1999-4915
• DOI: 10.3390/v12050556

Next-generation sequencing (NGS) is likely to become the new standard method for HIV drug resistance (HIVDR) genotyping. Despite the significant advances in the development of wet-lab protocols and bioinformatic data processing pipelines, one often-missing critical component of an NGS HIVDR assay for clinical use is external quality assessment (EQA). EQA is essential for ensuring assay consistency and laboratory competency in performing routine biomedical assays, and the rollout of NGS HIVDR tests in clinical practice will require an EQA. In September 2019, the 2 International Symposium on NGS HIVDR was held in Winnipeg, Canada. It convened a multidisciplinary panel of experts, including research scientists, clinicians, bioinformaticians, laboratory biologists, biostatisticians, and EQA experts. A themed discussion was conducted on EQA strategies towards such assays during the symposium. This article describes the logistical challenges identified and summarizes the opinions and recommendations derived from these discussions, which may inform the development of an inaugural EQA program for NGS HIVDR in the near future.