Direction de la vigie sanitaire, Ministère de la Santé et des Services sociaux du Québec, QC.
Département de médecine sociale et préventive, Faculté de Médecine, Université Laval, Québec, QC.
Can Commun Dis Rep. 2021 Dec 9;47(12):534-542. doi: 10.14745/ccdr.v47i12a04.
This PRONTO study investigated the clinical performance of the Abbott ID NOW (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results.
Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec.
Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2-98.0%) and 99.1% (95% CI: 97.6-99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7-99.6%) and 99.8% (95% CI: 99.5-100%), respectively. Turnaround time for positive results was significantly faster on IDN.
In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.
本 PRONTO 研究调查了 Abbott ID NOW（IDN）即时 COVID-19 诊断检测在即时护理点的临床性能及其对检测结果公布周转时间的影响。
2020 年 12 月至 2021 年 2 月，在魁北克省的三个门诊中心对有急性症状的参与者进行了前瞻性研究。
从 2372 名参与者中获得了有效的配对样本。IDN 或标准护理核酸扩增检测（SOC-NAAT）的阳性结果在 423 名参与者中获得（患病率为 17.8%）。IDN 和 SOC-NAAT 的总体灵敏度分别为 96.4%（95%CI：94.2-98.0%）和 99.1%（95%CI：97.6-99.8%）；阴性预测值分别为 99.2%（95%CI：98.7-99.6%）和 99.8%（95%CI：99.5-100%）。IDN 的阳性结果周转时间明显更快。
根据我们的经验，IDN 在门诊中心有症状的个体中的使用是对 SOC-NAAT 的可靠敏感替代方法，无需随后确认阴性结果。这种部署可以加速接触者追踪，减轻实验室的负担并增加检测的可及性。
