Service de microbiologie, CIUSSS de l'Estrie-Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.
Département de microbiologie et infectiologie, Université de Sherbrooke, Sherbrooke, Québec, Canada.
J Med Virol. 2022 Sep;94(9):4522-4527. doi: 10.1002/jmv.27847. Epub 2022 May 18.
The Abbott ID NOW™ COVID-19 assay has been shown as a reliable and sensitive alternative to reverse transcription-polymerase chain reaction (RT-PCR) testing from nasopharyngeal or nasal samples in symptomatic patients. Water gargle is an acceptable noninvasive alternative specimen for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) detection by RT-PCR. The objective of this study was to evaluate the performance of water gargle samples for the detection of SARS-CoV-2 using the ID NOW. Residual gargle samples were randomly selected among positive standard of care (SOC)-nucleic acid amplification test (NAAT) samples. For testing on ID NOW, the manufacturer's instructions were followed, except for the specimen addition step: 500 µl of the gargle specimen was added to the blue sample receiver with a pipette and gently mixed. Among the 202 positive samples by SOC-NAAT, 185 were positive by ID NOW (positive percent agreement [PPA]) = 91.6% (95% confidence interval [CI]: 86.9-95.0). For the 17 discordant samples, cycle threshold (C ) values were all ≥31.0. The PPA was significantly lower among asymptomatic patients (84.4%; 95% CI: 73.2-92.3) versus symptomatic patients (95.2%; 95% CI: 89.8-98.2). The performance of the ID NOW for the detection of SARS-CoV-2 infection on gargle samples is excellent when C values are <31.0 and for patients that have COVID-19 compatible symptoms.
ID NOW 即时 COVID-19 检测已被证明是一种可靠且灵敏的替代方法，可以替代鼻咽或鼻腔样本的逆转录-聚合酶链反应（RT-PCR）检测，用于有症状的患者。对于严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的 RT-PCR 检测，水漱口是一种可接受的非侵入性替代样本。本研究的目的是评估 ID NOW 检测水漱口样本用于检测 SARS-CoV-2 的性能。在阳性标准护理（SOC）-核酸扩增试验（NAAT）样本中随机选择残留的漱口样本。对于 ID NOW 检测，遵循制造商的说明，但不包括添加样本的步骤：用移液器将 500µl 漱口样本加入蓝色样本接收器中，并轻轻混合。在 202 个通过 SOC-NAAT 检测呈阳性的样本中，有 185 个通过 ID NOW 检测呈阳性（阳性百分率一致[PPA]）=91.6%（95%置信区间[CI]：86.9-95.0）。对于 17 个不一致的样本，循环阈值（C）值均≥31.0。无症状患者（84.4%；95%CI：73.2-92.3）的 PPA 明显低于有症状患者（95.2%；95%CI：89.8-98.2）。当 C 值<31.0 且患者具有 COVID-19 相关症状时，ID NOW 对 SARS-CoV-2 感染的检测性能在漱口样本上非常出色。
