Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Clin Microbiol Infect. 2023 Jan;29(1):94-100. doi: 10.1016/j.cmi.2022.07.010. Epub 2022 Jul 19.
OBJECTIVE: To define the relationship of SARS-CoV-2 antigen, viral load determined by RT-qPCR, and viral culture detection. Presumptively, viral culture can provide a surrogate measure for infectivity of sampled individuals and thereby inform how and where to most appropriately deploy antigen and nucleic acid amplification-based diagnostic testing modalities. METHODS: We compared the antigen testing results from three lateral flow and one microfluidics assay to viral culture detection and viral load determination performed in parallel in up to 189 nasopharyngeal swab samples positive for SARS-CoV-2. Sample viral loads, determined by RT-qPCR, were distributed across the range of viral load values observed in our testing population. RESULTS: Antigen tests were predictive of viral culture positivity, with the LumiraDx microfluidics method showing enhanced sensitivity (90%; 95% CI 83-94%) compared with the BD Veritor (74%, 95% CI 65-81%), CareStart (74%, 95% CI 65-81%) and Oscar Corona (74%, 95% CI 65-82%) lateral flow antigen tests. Antigen and viral culture positivity were also highly correlated with sample viral load, with areas under the receiver operator characteristic curves of 0.94 to 0.97 and 0.92, respectively. A viral load threshold of 100 000 copies/mL was 95% sensitive (95% CI, 90-98%) and 72% specific (95% CI, 60-81%) for predicting viral culture positivity. Adjusting for sample dilution inherent in our study design, sensitivities of antigen tests were ≥95% for detection of viral culture positive samples with viral loads >10 genome copies/mL, although specificity of antigen testing was imperfect. DISCUSSION: Antigen testing results and viral culture were correlated. For culture positive samples, the sensitivity of antigen tests was high at high viral loads that are likely associated with significant infectivity. Therefore, our data provides support for use of antigen testing in ruling out infectivity at the time of sampling.
目的:定义 SARS-CoV-2 抗原、通过 RT-qPCR 确定的病毒载量与病毒培养检测之间的关系。推测病毒培养可以为采样个体的感染性提供替代衡量标准,从而告知如何以及在何处最适当地部署抗原和核酸扩增诊断检测方式。
方法:我们比较了三种侧向流动检测法和一种微流控检测法的抗原检测结果与平行进行的多达 189 份鼻咽拭子样本的病毒培养检测和病毒载量测定结果,这些样本均为 SARS-CoV-2 阳性。通过 RT-qPCR 确定的样本病毒载量分布在我们检测人群中观察到的病毒载量值范围内。
结果:抗原检测可预测病毒培养阳性,LumiraDx 微流控法的灵敏度(90%;95%CI,83-94%)高于 BD Veritor(74%;95%CI,65-81%)、CareStart(74%;95%CI,65-81%)和 Oscar Corona(74%;95%CI,65-82%)侧向流动抗原检测。抗原和病毒培养阳性与样本病毒载量也高度相关,受试者工作特征曲线下面积分别为 0.94 至 0.97 和 0.92。病毒载量阈值为 100000 拷贝/mL 时,对预测病毒培养阳性的灵敏度为 95%(95%CI,90-98%),特异性为 72%(95%CI,60-81%)。调整本研究设计中固有的样本稀释因素后,抗原检测的灵敏度≥95%,可检测病毒载量>10 个基因组拷贝/mL 的病毒培养阳性样本,但抗原检测的特异性并不完美。
讨论:抗原检测结果与病毒培养相关。对于培养阳性的样本,抗原检测在高病毒载量时具有较高的灵敏度,而高病毒载量可能与显著的传染性相关。因此,我们的数据支持在采样时使用抗原检测来排除感染性。
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