Partial ORF1ab Gene Target Failure with Omicron BA.2.12.1.

Partial ORF1ab Gene Target Failure with Omicron BA.2.12.1.
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DOI:
10.1128/jcm.00600-22
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发表时间:
2022-06-15
影响因子:
9.4
通讯作者:
--
中科院分区:
医学2区
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SARS-CoV-2 基因组突变会影响分子诊断检测的性能。在某些情况下,例如 S 基因目标失败,其影响可以作为特定 SARS-CoV-2 变体的独特指标,并提供快速检测的方法。在这里,我们描述了 cobas SARS-CoV-2 检测中的部分 ORF1ab 基因靶标失败 (pOGTF),定义为与 E 基因相比,ORF1ab 基因检测的热循环延迟≥2 个。我们证明 pOGTF 对 SARS-CoV-2 谱系 BA.2.12.1 具有 98.6% 的敏感性和 99.9% 的特异性,该谱系是美国的一种新兴变体,具有尖峰 L452Q 和 S704L 突变,可能影响传播、传染性和/或免疫逃避。 pOGTF 比率的增加密切反映了上传到公共数据库的 BA.2.12.1 序列的比率,而且重要的是,pOGTF 本地比率的增加也反映了总体测试阳性率的增加。使用 pOGTF 作为 BA.2.12.1 的代理可以比全基因组测序更快地跟踪变异,并且可以使没有测序能力的实验室受益。
Mutations in the genome of SARS-CoV-2 can affect the performance of molecular diagnostic assays. In some cases, such as S-gene target failure, the impact can serve as a unique indicator of a particular SARS-CoV-2 variant and provide a method for rapid detection. Here, we describe partial ORF1ab gene target failure (pOGTF) on the cobas SARS-CoV-2 assays, defined by a ≥2-thermocycle delay in detection of the ORF1ab gene compared to that of the E-gene. We demonstrate that pOGTF is 98.6% sensitive and 99.9% specific for SARS-CoV-2 lineage BA.2.12.1, an emerging variant in the United States with spike L452Q and S704L mutations that may affect transmission, infectivity, and/or immune evasion. Increasing rates of pOGTF closely mirrored rates of BA.2.12.1 sequences uploaded to public databases, and, importantly, increasing local rates of pOGTF also mirrored increasing overall test positivity. Use of pOGTF as a proxy for BA.2.12.1 provides faster tracking of the variant than whole-genome sequencing and can benefit laboratories without sequencing capabilities.
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