PDF(Pubmed)
Abstract：
COVID-19 laboratory diagnosis primarily relies on molecular tests, highly sensitive during early infection stages with high viral loads. As the disease progresses, sensitivity decreases, requiring antibody detection. Since the beginning of the pandemic, serological tests have been developed and made available in Brazil, but their diagnostic performance varies. This study evaluated the IBMP ELISA IgA/IgM/IgG COVID-19 kit performance in detecting SARS-CoV-2 antibodies. A total of 90 samples, including 64 from COVID-19 patients and 26 pre-pandemic donors, were assessed based on time post symptom onset (0-7, 8-14, and 15-21 days). The kit showed 61% sensitivity, 100% specificity, and 72% accuracy overall. Sensitivity varied with time, being 25%, 57%, and 96% for 0-7, 8-14, and 15-21 days, respectively. Similar variations were noted in other commercial tests. The Gold ELISA COVID-19 (IgG/IgM) had sensitivities of 31%, 71%, and 100%, while the Anti-SARS-CoV-2 NCP ELISA (IgG) and Anti-SARS-CoV-2 NCP ELISA (IgM) showed varying sensitivities. The IBMP ELISA kit displayed high diagnostic capability, especially as the disease progressed, complementing COVID-19 diagnosis. Reproducibility assessment revealed minimal systematic and analytical errors. In conclusion, the IBMP ELISA IgA/IgM/IgG COVID-19 kit is a robust tool for detecting anti-SARS-CoV-2 antibodies, increasing in efficacy over the disease course, and minimizing false negatives in RT-PCR COVID-19 diagnosis.
摘要：
COVID-19实验室诊断主要依靠分子检测，在高病毒载量的早期感染阶段高度敏感。随着疾病的进展,灵敏度降低,需要抗体检测。自从大流行开始以来，在巴西已经开发并提供了血清学测试，但它们的诊断性能各不相同。本研究评估了IBMPELISAIgA/IgM/IgGCOVID-19试剂盒检测SARS-CoV-2抗体的性能。共有90个样本,包括64名来自COVID-19患者和26名流行前捐赠者，根据症状发作后的时间（0-7、8-14和15-21天）进行评估。试剂盒显示61%的灵敏度，100%特异性,总体准确率为72%。灵敏度随时间变化，25%,57%,在0-7、8-14和15-21天内为96%，分别。在其他商业测试中注意到类似的变化。GoldELISACOVID-19(IgG/IgM)的敏感性为31%,71%,100%,而抗SARS-CoV-2NCPELISA（IgG）和抗SARS-CoV-2NCPELISA（IgM）显示出不同的敏感性。IBMPELISA试剂盒显示出高诊断能力，尤其是随着疾病的发展，补充COVID-19诊断。重复性评估显示，系统和分析误差最小。总之,IBMPELISAIgA/IgM/IgGCOVID-19试剂盒是检测抗SARS-CoV-2抗体的强大工具，在疾病过程中提高疗效，并尽量减少RT-PCR诊断COVID-19的假阴性。
