PDF(Pubmed)
Abstract：
UNASSIGNED: The emergence of SARS-CoV-2 has triggered a global pandemic with profound implications for public health. Rapid changes in the pandemic landscape and limitations in in vitro diagnostics led to the introduction of numerous diagnostic devices with variable performance. In this study, we evaluated three commercial serological assays in Brazil for detecting anti-SARS-CoV-2 antibodies.
UNASSIGNED: We collected 90 serum samples from SARS-CoV-2-negative blood donors and 352 from SARS-CoV-2-positive, unvaccinated patients, categorized by symptom onset. Subsequently, we assessed the diagnostic performance of three commercial enzyme immunoassays: GOLD ELISA (enzyme-linked immunosorbent assay) COVID-19 Ig (immunoglobulin) G + IgM, Anti-SARS-CoV-2 NCP IgM ELISA, and Anti-SARS-CoV-2 NCP IgG ELISA.
UNASSIGNED: Our findings revealed that the GOLD ELISA COVID-19 IgG + IgM exhibited the highest sensitivity (57.7%) and diagnostic odds ratio, surpassing the manufacturer\'s reported sensitivity in most analyzed time frames while maintaining exceptional specificity (98.9%). Conversely, the Anti-SARS-CoV-2 NCP IgG ELISA demonstrated lower sensitivity but aligned with independent evaluations, boasting a specificity of 100%. However, the Anti-SARS-CoV-2 NCP IgM ELISA exhibited lower sensitivity than claimed, particularly in samples collected shortly after positive reverse transcription polymerase chain reaction results. Performance improved 15-21 days after symptom onset and beyond 22 days, but in the first week, both Anti-SARS-CoV-2 NCP IgM ELISA and Anti-SARS-CoV-2 NCP IgG ELISA struggled to differentiate positive and negative samples.
UNASSIGNED: Our study emphasizes the need for standardized validation protocols to address discrepancies between manufacturer-claimed and actual performance. These insights provide essential information for health care practitioners and policymakers regarding the diagnostic capabilities of these assays in various clinical scenarios.
UNASSIGNED: We collected 90 serum samples from SARS-CoV-2-negative blood donors and 352 from SARS-CoV-2-positive, unvaccinated patients, categorized by symptom onset. Subsequently, we assessed the diagnostic performance of three commercial enzyme immunoassays: GOLD ELISA (enzyme-linked immunosorbent assay) COVID-19 Ig (immunoglobulin) G + IgM, Anti-SARS-CoV-2 NCP IgM ELISA, and Anti-SARS-CoV-2 NCP IgG ELISA.
UNASSIGNED: Our findings revealed that the GOLD ELISA COVID-19 IgG + IgM exhibited the highest sensitivity (57.7%) and diagnostic odds ratio, surpassing the manufacturer\'s reported sensitivity in most analyzed time frames while maintaining exceptional specificity (98.9%). Conversely, the Anti-SARS-CoV-2 NCP IgG ELISA demonstrated lower sensitivity but aligned with independent evaluations, boasting a specificity of 100%. However, the Anti-SARS-CoV-2 NCP IgM ELISA exhibited lower sensitivity than claimed, particularly in samples collected shortly after positive reverse transcription polymerase chain reaction results. Performance improved 15-21 days after symptom onset and beyond 22 days, but in the first week, both Anti-SARS-CoV-2 NCP IgM ELISA and Anti-SARS-CoV-2 NCP IgG ELISA struggled to differentiate positive and negative samples.
UNASSIGNED: Our study emphasizes the need for standardized validation protocols to address discrepancies between manufacturer-claimed and actual performance. These insights provide essential information for health care practitioners and policymakers regarding the diagnostic capabilities of these assays in various clinical scenarios.
摘要：
SARS-CoV-2的出现引发了全球大流行，对公共卫生产生了深远的影响。大流行格局的快速变化和体外诊断的局限性导致引入了许多具有可变性能的诊断设备。在这项研究中,我们评估了巴西三种商业血清学检测方法，用于检测抗SARS-CoV-2抗体。
■我们从SARS-CoV-2阴性献血者中收集了90份血清样本，从SARS-CoV-2阳性献血者中收集了352份血清样本，未接种疫苗的患者，按症状发作分类。随后，我们评估了三种商业酶免疫测定的诊断性能：GOLDELISA（酶联免疫吸附测定）COVID-19Ig（免疫球蛋白）GIgM，抗SARS-CoV-2NCPIgMELISA,和抗SARS-CoV-2NCPIgGELISA。
■我们的研究结果表明，GOLDELISACOVID-19IgGIgM表现出最高的敏感性（57.7％）和诊断优势比，在大多数分析时间范围内超过制造商报告的灵敏度，同时保持异常特异性（98.9%）。相反，抗SARS-CoV-2NCPIgGELISA显示灵敏度较低，但与独立评估一致，具有100%的特异性。然而,抗SARS-CoV-2NCPIgMELISA显示出比声称更低的灵敏度，特别是在逆转录聚合酶链反应阳性结果后不久收集的样品中。症状出现后15-21天和超过22天，性能改善，但在第一周,抗SARS-CoV-2NCPIgMELISA和抗SARS-CoV-2NCPIgGELISA难以区分阳性和阴性样品。
■我们的研究强调需要标准化的验证方案，以解决制造商声称和实际性能之间的差异。这些见解为医疗保健从业人员和决策者提供了有关这些测定在各种临床情况下的诊断能力的基本信息。
■我们从SARS-CoV-2阴性献血者中收集了90份血清样本，从SARS-CoV-2阳性献血者中收集了352份血清样本，未接种疫苗的患者，按症状发作分类。随后，我们评估了三种商业酶免疫测定的诊断性能：GOLDELISA（酶联免疫吸附测定）COVID-19Ig（免疫球蛋白）GIgM，抗SARS-CoV-2NCPIgMELISA,和抗SARS-CoV-2NCPIgGELISA。
■我们的研究结果表明，GOLDELISACOVID-19IgGIgM表现出最高的敏感性（57.7％）和诊断优势比，在大多数分析时间范围内超过制造商报告的灵敏度，同时保持异常特异性（98.9%）。相反，抗SARS-CoV-2NCPIgGELISA显示灵敏度较低，但与独立评估一致，具有100%的特异性。然而,抗SARS-CoV-2NCPIgMELISA显示出比声称更低的灵敏度，特别是在逆转录聚合酶链反应阳性结果后不久收集的样品中。症状出现后15-21天和超过22天，性能改善，但在第一周,抗SARS-CoV-2NCPIgMELISA和抗SARS-CoV-2NCPIgGELISA难以区分阳性和阴性样品。
■我们的研究强调需要标准化的验证方案，以解决制造商声称和实际性能之间的差异。这些见解为医疗保健从业人员和决策者提供了有关这些测定在各种临床情况下的诊断能力的基本信息。
