在旧金山的一个社区检测点,针对不断演变的奥密克戎浪潮,对 BinaxNOW 抗原检测作为 COVID-19 治疗切入点进行现场评估。

Field assessment of BinaxNOW antigen tests as COVID-19 treatment entry point at a community testing site in San Francisco during evolving omicron surges.

机构信息

Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, United States of America.

Chan Zuckerberg Biohub, San Francisco, California, United States of America.

出版信息

PLoS One. 2023 Mar 24;18(3):e0283576. doi: 10.1371/journal.pone.0283576. eCollection 2023.

Abstract

COVID-19 oral treatments require initiation within 5 days of symptom onset. Although antigen tests are less sensitive than RT-PCR, rapid results could facilitate entry to treatment. We collected anterior nasal swabs for BinaxNOW and RT-PCR testing and clinical data at a walk-up, community site in San Francisco, California between January and June 2022. SARS-CoV-2 genomic sequences were generated from positive samples and classified according to subtype and variant. Monte Carlo simulations were conducted to estimate the expected proportion of SARS-CoV-2 infected persons who would have been diagnosed within 5 days of symptom onset using RT-PCR versus BinaxNOW testing. Among 25,309 persons tested with BinaxNOW, 2,799 had concomitant RT-PCR. 1137/2799 (40.6%) were SARS-CoV-2 RT-PCR positive. We identified waves of predominant omicron BA.1, BA.2, BA.2.12, BA.4, and BA.5 among 720 sequenced samples. Among 1,137 RT-PCR positive samples, 788/1137 (69%) were detected by BinaxNOW; 94% (669/711) of those with Ct value <30 were detected by BinaxNOW. BinaxNOW detection was consistent over lineages. In analyses to evaluate entry to treatment, BinaxNOW detected 81.7% (361/442, 95% CI: 77-85%) of persons with COVID-19 within 5 days of symptom onset. In comparison, RT-PCR (24-hour turnaround) detected 84.2% (372/442, 95% CI: 80-87%) and RT-PCR (48-hour turnaround) detected 67.0% (296/442, 95% CI: 62-71%) of persons with COVID-19 within 5 days of symptom onset. BinaxNOW detected high viral load from anterior nasal swabs consistently across omicron sublineages emerging between January and June of 2022. Simulations support BinaxNOW as an entry point for COVID-19 treatment in a community field setting.

摘要

COVID-19 口服治疗需要在症状出现后 5 天内开始。虽然抗原检测不如 RT-PCR 敏感,但快速结果可以促进进入治疗。我们在加利福尼亚州旧金山的一个社区现场收集了前鼻拭子,用于 BinaxNOW 和 RT-PCR 检测和临床数据,时间为 2022 年 1 月至 6 月。从阳性样本中生成了 SARS-CoV-2 基因组序列,并根据亚型和变体进行了分类。进行了蒙特卡罗模拟,以估计使用 RT-PCR 与 BinaxNOW 检测在症状出现后 5 天内诊断出 SARS-CoV-2 感染患者的预期比例。在接受 BinaxNOW 检测的 25309 人中,有 2799 人同时进行了 RT-PCR 检测。1137/2799(40.6%)为 SARS-CoV-2 RT-PCR 阳性。在 720 个测序样本中,我们发现了 omicron BA.1、BA.2、BA.2.12、BA.4 和 BA.5 的主要波。在 1137 份 RT-PCR 阳性样本中,788/1137(69%)被 BinaxNOW 检测到;94%(669/711)Ct 值<30 的样本被 BinaxNOW 检测到。BinaxNOW 的检测在谱系之间是一致的。在评估进入治疗的分析中,BinaxNOW 在症状出现后 5 天内检测到 81.7%(361/442,95%CI:77-85%)的 COVID-19 患者。相比之下,RT-PCR(24 小时周转时间)检测到 84.2%(372/442,95%CI:80-87%)和 RT-PCR(48 小时周转时间)检测到 67.0%(296/442,95%CI:62-71%)的 COVID-19 患者在症状出现后 5 天内。BinaxNOW 在前鼻拭子中检测到的病毒载量在 2022 年 1 月至 6 月期间出现的 omicron 亚谱系中始终保持较高水平。模拟结果支持 BinaxNOW 作为社区实地环境中 COVID-19 治疗的切入点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/648b/10038282/d5482a0fa4d1/pone.0283576.g001.jpg

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