The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2.
The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2.
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DOI：
10.1016/j.jiac.2021.07.006
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发表时间：
2021-10
期刊：
影响因子：
--
通讯作者：
Suzuki H
中科院分区：
文献类型：
--
作者：
Kurihara Y;Kiyasu Y;Akashi Y;Takeuchi Y;Narahara K;Mori S;Takeshige T;Notake S;Ueda A;Nakamura K;Ishikawa H;Suzuki H
快速抗原检测便于诊断严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）；但与核酸扩增试验相比，其敏感性较低。在这项研究中，我们评估了Quick Chaser®Auto SARS-CoV-2的诊断性能，这是一种新型的数字免疫层析检测，预计比传统抗原检测具有更高的灵敏度。一项前瞻性观察研究于2021年2月8日至3月24日进行。我们同时获得两份鼻咽样本，一份用于QuickChaser®Auto SARS-CoV-2抗原检测，另一份用于反转录PCR （RT-PCR）评估，后者被认为是金标准参考测试。将新抗原检测方法的检出限（LOD）与其他四种市售快速抗原检测方法进行了比较。共分析1401份样本。参考RT-PCR检测到SARS-CoV-2 83份（5.9%），其中有症状患者36份（43.4%）。敏感性、特异性、阳性预测值和阴性预测值分别为74.7%（95%置信区间（CI）： 64.0 ~ 83.6%）、99.8% （95% CI: 99.5 ~ 100%）、96.9% （95% CI: 89.2 ~ 99.6%）和98.4% （95% CI: 97.6 ~ 99.0%）。当局限于周期阈值(Ct) < 30的样本或来自有症状患者的样本时，敏感性分别增加到98.3%和88.9%。QuickChaser®Auto SARS-CoV-2检测到34-120拷贝/次，比其他快速抗原检测灵敏度更高。QuickChaser®Auto SARS-CoV-2在有症状患者的临床样本中表现出足够的敏感性和特异性。在Ct < 30的样品中，灵敏度与RT-PCR相当。
Rapid antigen tests are convenient for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); however, they have lower sensitivities than nucleic acid amplification tests. In this study, we evaluated the diagnostic performance of Quick Chaser® Auto SARS-CoV-2, a novel digital immunochromatographic assay that is expected to have higher sensitivity than conventional antigen tests. A prospective observational study was conducted between February 8 and March 24, 2021. We simultaneously obtained two nasopharyngeal samples, one for evaluation with the QuickChaser® Auto SARS-CoV-2 antigen test and the other for assessment with reverse transcription PCR (RT-PCR), considered the gold-standard reference test. The limit of detection (LOD) of the new antigen test was compared with those of four other commercially available rapid antigen tests. A total of 1401 samples were analyzed. SARS-CoV-2 was detected by reference RT-PCR in 83 (5.9%) samples, of which 36 (43.4%) were collected from symptomatic patients. The sensitivity, specificity, positive predictive value, and negative predictive value were 74.7% (95% confidence interval (CI): 64.0–83.6%), 99.8% (95% CI: 99.5–100%), 96.9% (95% CI: 89.2–99.6%), and 98.4% (95% CI: 97.6–99.0%), respectively. When limited to samples with a cycle threshold (Ct) < 30 or those from symptomatic patients, the sensitivity increased to 98.3% and 88.9%, respectively. The QuickChaser® Auto SARS-CoV-2 detected 34–120 copies/test, which indicated greater sensitivity than the other rapid antigen tests. QuickChaser® Auto SARS-CoV-2 showed sufficient sensitivity and specificity in clinical samples of symptomatic patients. The sensitivity was comparable to RT-PCR in samples with Ct < 30.
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影响因子：
15.1
作者：
Gremmels H;Winkel BMF;Schuurman R;Rosingh A;Rigter NAM;Rodriguez O;Ubijaan J;Wensing AMJ;Bonten MJM;Hofstra LM
通讯作者：
Hofstra LM
DOI：
10.1016/j.cmi.2020.12.022
发表时间：
2021-04
期刊：
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
影响因子：
--
作者：
Torres I;Poujois S;Albert E;Colomina J;Navarro D
通讯作者：
Navarro D
影响因子：
11.8
作者：
Bullard, Jared;Dust, Kerry;Poliquin, Guillaume
通讯作者：
Poliquin, Guillaume
影响因子：
9.4
作者：
Daley, Peter;Castriciano, Santina;Smieja, Marek
通讯作者：
Smieja, Marek
影响因子：
4
作者：
Kiyasu Y;Akashi Y;Sugiyama A;Takeuchi Y;Notake S;Naito A;Nakamura K;Ishikawa H;Suzuki H
通讯作者：
Suzuki H