雅培 BinaxNOW COVID-19 抗原卡测试的诊断准确性,波多黎各。

IF 4.3 4区 医学 Q1 INFECTIOUS DISEASES
Zachary J. Madewell, Chelsea G. Major, Nathan Graff, Cameron Adams, Dania M. Rodriguez, Tatiana Morales, Nicole A. Medina Lopes, Rafael Tosado, Liliana Sánchez-González, Janice Perez-Padilla, Hannah R. Volkman, Jorge Bertrán-Pasarell, Diego Sainz de la Peña, Jorge Munoz-Jordan, Gilberto A. Santiago, Olga Lorenzi, Vanessa Rivera-Amill, Melissa A. Rolfes, Gabriela Paz-Bailey, Laura E. Adams, Joshua M. Wong
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引用次数: 0

摘要

背景:COVID-19 大流行凸显了对快速准确诊断工具的需求。2020年8月,雅培BinaxNOW COVID-19抗原卡检测作为SARS-CoV-2分子检测的一种及时、经济的替代方法上市,但其性能可能因时间和症状等因素而有所不同。本研究评估了 BinaxNOW 在不同流行病学背景下的诊断性能:以 RT-PCR 为参考,我们评估了 BinaxNOW COVID-19 检验在 2020 年 12 月至 2023 年 5 月波多黎各两项研究参与者的前鼻拭子中检测 SARS-CoV-2 的性能。根据症状出现后的天数、采集策略、疫苗接种情况、症状、重复检测和 RT-PCR 周期阈值 (Ct) 值对检测性能进行了评估:BinaxNOW的总体灵敏度为84.1%,特异性为98.8%。灵敏度在症状出现后 1-6 天内达到峰值(93.2%),有症状者的灵敏度(86.3%)高于无症状者(67.3%)。在感染过程中,灵敏度有所下降,从最初检测的 96.3% 降至 7-14 天后检测的 48.4%。BinaxNOW 对低 Ct 值(≤ 25)参与者的灵敏度为 99.5%,但对高 Ct 值(36-40)参与者的灵敏度较低(18.2%):BinaxNOW显示出较高的灵敏度和特异性,尤其是在早期感染和有症状的参与者中。在检测灵敏度对临床决策至关重要的情况下,核酸扩增检测是首选。这些发现凸显了在解释检测结果时考虑临床和流行病学背景的重要性,并强调有必要持续开展研究,以调整检测策略,适应新出现的 SARS-CoV-2 变体。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Diagnostic Accuracy of the Abbott BinaxNOW COVID-19 Antigen Card Test, Puerto Rico

Diagnostic Accuracy of the Abbott BinaxNOW COVID-19 Antigen Card Test, Puerto Rico

Background

The COVID-19 pandemic underscored the need for rapid and accurate diagnostic tools. In August 2020, the Abbott BinaxNOW COVID-19 Antigen Card test became available as a timely and affordable alternative for SARS-CoV-2 molecular testing, but its performance may vary due to factors including timing and symptomatology. This study evaluates BinaxNOW diagnostic performance in diverse epidemiological contexts.

Methods

Using RT-PCR as reference, we assessed performance of the BinaxNOW COVID-19 test for SARS-CoV-2 detection in anterior nasal swabs from participants of two studies in Puerto Rico from December 2020 to May 2023. Test performance was assessed by days post symptom onset, collection strategy, vaccination status, symptomatology, repeated testing, and RT-PCR cycle threshold (Ct) values.

Results

BinaxNOW demonstrated an overall sensitivity of 84.1% and specificity of 98.8%. Sensitivity peaked within 1–6 days after symptom onset (93.2%) and was higher for symptomatic (86.3%) than asymptomatic (67.3%) participants. Sensitivity declined over the course of infection, dropping from 96.3% in the initial test to 48.4% in testing performed 7–14 days later. BinaxNOW showed 99.5% sensitivity in participants with low Ct values (≤ 25) but lower sensitivity (18.2%) for participants with higher Cts (36–40).

Conclusions

BinaxNOW demonstrated high sensitivity and specificity, particularly in early-stage infections and symptomatic participants. In situations where test sensitivity is crucial for clinical decision-making, nucleic acid amplification tests are preferred. These findings highlight the importance of considering clinical and epidemiological context when interpreting test results and emphasize the need for ongoing research to adapt testing strategies to emerging SARS-CoV-2 variants.

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来源期刊
CiteScore
7.20
自引率
4.50%
发文量
120
审稿时长
6-12 weeks
期刊介绍: Influenza and Other Respiratory Viruses is the official journal of the International Society of Influenza and Other Respiratory Virus Diseases - an independent scientific professional society - dedicated to promoting the prevention, detection, treatment, and control of influenza and other respiratory virus diseases. Influenza and Other Respiratory Viruses is an Open Access journal. Copyright on any research article published by Influenza and Other Respiratory Viruses is retained by the author(s). Authors grant Wiley a license to publish the article and identify itself as the original publisher. Authors also grant any third party the right to use the article freely as long as its integrity is maintained and its original authors, citation details and publisher are identified.
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