National HIV and Retrovirology Laboratories at JC Wilt Infectious Diseases Research Centre, Public Health Agency of Canada, Winnipeg, MB R3E 3R2, Canada.
Department of Medical Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, MB R3E 0J9, Canada.
Viruses. 2020 May 18;12(5):556. 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.
下一代测序(NGS)可能成为 HIV 耐药性(HIVDR)基因分型的新标准方法。尽管在湿实验室方案和生物信息学数据处理管道的开发方面取得了重大进展,但 NGS HIVDR 检测用于临床的一个经常缺失的关键组件是外部质量评估(EQA)。EQA 对于确保检测一致性和实验室执行常规生物医学检测的能力至关重要,NGS HIVDR 检测在临床实践中的推出将需要 EQA。2019 年 9 月,第二届 NGS HIVDR 国际研讨会在加拿大温尼伯举行。它召集了多学科专家小组,包括研究科学家、临床医生、生物信息学家、实验室生物学家、生物统计学家和 EQA 专家。在研讨会上就此类检测的 EQA 策略进行了主题讨论。本文描述了确定的后勤挑战,并总结了这些讨论中得出的意见和建议,这些意见和建议可能为未来不久 NGS HIVDR 的首次 EQA 计划的制定提供信息。