关键词: COVID-19 Panbio COVID-19/Flu A&B Panel SARS-CoV-2 cobas SARS-CoV-2 & Influenza A/B qualitative assay sensitivity specificity

Mesh : Humans COVID-19 / diagnosis Influenza, Human / diagnosis virology Sensitivity and Specificity Influenza B virus / isolation & purification immunology SARS-CoV-2 / immunology isolation & purification Adult Middle Aged Female Male Antigens, Viral / analysis immunology Young Adult Adolescent Aged Influenza A virus / isolation & purification immunology Child Child, Preschool Nasopharynx / virology COVID-19 Testing / methods Infant Aged, 80 and over

来  源:   DOI:10.1128/jcm.00207-24   PDF(Pubmed)

Abstract:
The Panbio COVID-19/Flu A&B Panel (Abbott) is an in vitro diagnostic rapid test designed for the qualitative detection of nucleocapsid proteins SARS-CoV-2 and nucleoprotein influenza A and B antigens in nasal mid-turbinate (NMT) swab specimens from symptomatic individuals meeting COVID-19 and influenza clinical and/or epidemiological criteria. This study, the largest global one to date using fresh samples, aimed to assess the diagnostic sensitivity and specificity of the Panbio COVID-19/Flu A&B Panel in freshly collected NMT swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or influenza within the first 5 days of symptom onset compared with results obtained with the cobas SARS-CoV-2 and influenza A/B qualitative assay (cobas 6800/8800 systems), which were tested using nasopharyngeal swab samples. A total of 512 evaluable subjects were enrolled in the COVID-19 cohort across 18 sites, and 1,148 evaluable subjects were enrolled in the influenza cohort across 22 sites in the Asia-Pacific, Europe, and the USA. The Panbio COVID-19/Flu A&B Panel demonstrated a sensitivity of 80.4% and a specificity of 99.7% for COVID-19. For influenza A, the sensitivity and specificity rates were 80.6% and 99.3%, respectively. Likewise, for influenza B, the sensitivity and specificity rates were 80.8% and 99.4%, respectively. In conclusion, the Panbio COVID-19/Flu A&B Panel emerges as a suitable rapid test for detecting COVID-19 and influenza in symptomatic subjects across diverse global populations, exhibiting high sensitivity. The assay achieved a sensitivity of 94.4% in samples with Ct ≤24 for COVID-19 and 92.6% in samples with Ct ≤30 for influenza A and B.
OBJECTIVE: The Panbio COVID-19/Flu A&B Panel is a suitable rapid test for detecting COVID-19 and influenza in symptomatic subjects across diverse global populations, exhibiting high sensitivity. The assay achieved a sensitivity of 94.0% in samples with Ct ≤24 for COVID-19 and 92.6% in samples with Ct ≤30 for influenza A and B.
摘要:
PanbioCOVID-19/FluA&B小组(Abbott)是一种体外诊断快速测试,旨在定性检测来自符合COVID-19和流感临床和/或流行病学标准的有症状个体的鼻中鼻甲(NMT)拭子标本中的核衣壳蛋白SARS-CoV-2和核蛋白A和B抗原。这项研究,迄今为止使用新鲜样品的最大的全球样品,旨在评估PanbioCOVID-19/FluA&B小组在新收集的NMT拭子样本中的诊断敏感性和特异性,这些样本来自症状发作的头5天内疑似呼吸道病毒感染与COVID-19和/或流感一致的个体,与cobasSARS-CoV-2和流感A/B定性测定(cobas6800/8800系统)获得的结果相比,使用鼻咽拭子样本进行了测试。共有512名可评估的受试者被纳入18个地点的COVID-19队列,在亚太地区的22个地点的流感队列中招募了1,148名可评估受试者,欧洲,和美国。PanbioCOVID-19/流感A&B小组对COVID-19的敏感性为80.4%,特异性为99.7%。对于甲型流感,敏感性和特异性分别为80.6%和99.3%,分别。同样,乙型流感,敏感性和特异性分别为80.8%和99.4%,分别。总之,PanbioCOVID-19/流感A&B小组成为一种合适的快速检测方法,用于检测全球不同人群有症状的受试者中的COVID-19和流感,表现出高灵敏度。该检测在Ct≤24的样本中对COVID-19的灵敏度为94.4%,在Ct≤30的样本中对甲型和乙型流感的灵敏度为92.6%。
目标:PanbioCOVID-19/FluA&BPanel是一种合适的快速检测方法,可用于检测全球不同人群有症状受试者中的COVID-19和流感,表现出高灵敏度。该测定在Ct≤24的样品中对COVID-19的灵敏度为94.0%,在Ct≤30的样品中对甲型和乙型流感的灵敏度为92.6%。
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