用于检测SARS-CoV-2变体的即时快速抗原检测方法的开发与性能
Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants.
作者信息
Liu Lihong, Meyers Kathrine, Purpura Lawrence J, Nguyen Nadia, Mohri Hiroshi, Chang Jennifer Y, Annavajhala Medini K, Lopez Leo, Lee Sang Won, Shah Jayesh, Lane Benjamin, Cantos Anyelina, Tukuru Sade A, Guo Yicheng, Ford Kenra, Chiu Yueh-Ting, Sheng Zizhang, Choesang Tenzin, Castor Delivette, Wang Maple, Pili Christina, Van Hoy Michael N, Wallach Andrew, Horton Jamie, Chen Zhiqiang, Rosenthal Susan, McLaren Son, Jiang Baowei, Wang Frank, Lu Helen H, Uhlemann Anne-Catrin, Ho David D, Yin Michael T
机构信息
Aaron Diamond AIDS Research Center, Columbia University, New York, NY, United States.
Department of Medicine, Infectious Diseases, Columbia University, New York, NY, United States.
出版信息
J Clin Virol Plus. 2022 Aug;2(3):100080. doi: 10.1016/j.jcvp.2022.100080. Epub 2022 May 4.
BACKGROUND
SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA).
METHODS
Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator.
RESULTS
In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants with sensitivity in the range of 0.2-3.2 ng/mL, and 10 authentic SARS-CoV-2 variants with sensitivity in the range of 1.6-12.5 TCID50/swab. No cross reactivity was observed with other human coronaviruses or other respiratory pathogens. In clinical point-of-care testing on 148 individuals over age 2 with symptoms of ≤5 days, PPA was 87.2% (CI 95: 78.3-94.8%) and NPA was 100% (CI 95: 94.2-100%). In another 884 asymptomatic individuals, PPA was 85.7% (CI 95: 42.1-99.6%) and 99.7% (99.0-99.9%). Overall, CoV-SCAN detected over 97.2% of specimens with CT values <30 and 93.8% of nasal swab specimens with the Omicron variant, even within the first 2 days after symptom onset.
CONCLUSIONS
The unique construction of CoV-SCAN using two pairs of monoclonal antibodies has resulted in a test with high performance that remains durable across multiple variants in both laboratory and clinical evaluations. CoV-SCAN should identify almost all individuals harboring infectious SARS-CoV-2.
SUMMARY
Unique construction of a point-of-care rapid antigen test using two pairs of monoclonal antibodies has led to good performance that remained durable across multiple variants in laboratory and clinical evaluations. Test should identify almost all individuals harboring infectious SARS-CoV-2.
背景
基于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗原的检测已针对传染性进行了良好校准，在2019冠状病毒病（COVID-19）公共卫生应对中发挥着关键作用。我们报告了一种独特的侧向流动免疫分析（LFA）的开发和性能。
方法
分离、评估并选择了几种靶向SARS-CoV-2核衣壳蛋白（NP）上多个抗原位点的单克隆抗体组合，用于开发一种名为CoV-SCAN（BioMedomics公司）的LFA。对有症状和无症状个体进行了临床即时检测研究，以评估与逆转录聚合酶链反应（RT-PCR）作为对照的阳性预测一致性（PPA）和阴性预测一致性（NPA）。
结果
在实验室检测中，CoV-SCAN检测到14种SARS-CoV-2变异株的重组N蛋白，灵敏度在0.2-3.2 ng/mL范围内，以及10种真实SARS-CoV-2变异株，灵敏度在1.6-12.5半数组织培养感染剂量（TCID50）/拭子范围内。未观察到与其他人类冠状病毒或其他呼吸道病原体的交叉反应。在对148名年龄≥2岁、症状持续≤5天的个体进行的临床即时检测中，PPA为87.2%（95%置信区间：78.3-94.8%），NPA为100%（95%置信区间：94.2-100%）。在另外884名无症状个体中，PPA为85.7%（95%置信区间：42.1-99.6%），NPA为99.7%（99.0-99.9%）。总体而言，CoV-SCAN检测到超过97.2%的CT值<30的标本以及93.8%的含有奥密克戎变异株的鼻拭子标本，即使在症状出现后的头2天内。
结论
CoV-SCAN使用两对单克隆抗体的独特构建使其在实验室和临床评估中对多种变异株都具有高性能且持久耐用。CoV-SCAN应能识别几乎所有携带传染性SARS-CoV-2的个体。
总结
使用两对单克隆抗体构建的即时快速抗原检测具有良好性能，在实验室和临床评估中对多种变异株都保持持久耐用。该检测应能识别几乎所有携带传染性SARS-CoV-2的个体。
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