Department of Medicine, Discipline of Infectious Diseases, Universidade Federal de São Paulo, São Paulo, Brazil.
Laboratório de Virologia Clínica, Universidade Federal de São Paulo, Rua Pedro de Toledo, 781 - Vila Clementino, São Paulo, SP, 04039-032, Brazil.
Braz J Microbiol. 2021 Sep;52(3):1161-1165. doi: 10.1007/s42770-021-00498-z. Epub 2021 Apr 19.
Since the coronavirus disease 2019 (COVID-19) pandemic, Brazil has the third-highest number of confirmed cases and the second-highest number of recovered patients. SARS-CoV-2 detection by real-time RT-PCR is the gold standard but requires a certified laboratory infrastructure with high-cost equipment and trained personnel. However, for large-scale testing, diagnostics should be fast, cost-effective, widely available, and deployed for the community, such as serological tests based on lateral flow immunoassay (LFIA) for IgM/IgG detection. We evaluated three different commercial point-of-care (POC) LFIAs for anti-SARS-CoV-2 IgM and IgG detection in capillary whole blood of 100 healthcare workers (HCW) from São Paulo university hospital previously tested by RT-PCR: (1) COVID-19 IgG/IgM BIO (Bioclin, Brazil), (2) Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Livzon, China), and (3) SARS-CoV-2 Antibody Test (Wondfo, China). A total of 84 positives and 16 negatives HCW were tested. The data was also analyzed by the number of days post symptoms (DPS) in three groups: <30 (n=26), 30-59 (n=42), and >59 (n=16). The observed sensibility was 85.71%, 47.62%, and 44.05% for Bioclin, Wondfo, and Livzon, respectively, with a specificity of 100% for all LFIA. Bioclin was more sensitive (p<0.01), regardless of the DPS. Thus, the Bioclin may be used as a POC test to monitor SARS-CoV-2 seroconversion in HCW.
自 2019 年冠状病毒病(COVID-19)大流行以来,巴西的确诊病例数位居第三,康复患者数位居第二。实时 RT-PCR 检测 SARS-CoV-2 是金标准,但需要具备认证实验室基础设施,配备高成本设备和经过培训的人员。然而,对于大规模检测,诊断方法应快速、具有成本效益、广泛可用并可在社区中部署,例如基于侧向流动免疫分析(LFIA)的 IgM/IgG 检测的血清学检测。我们评估了三种不同的商业即时护理(POC)LFIA 用于检测圣保罗大学医院 100 名医护人员(HCW)毛细血管全血中的抗 SARS-CoV-2 IgM 和 IgG:(1)COVID-19 IgG/IgM BIO(Bioclin,巴西),(2)冠状病毒(SARS-CoV-2)IgM/IgG 诊断试剂盒(Livzon,中国),和(3)SARS-CoV-2 抗体检测试剂盒(Wondfo,中国)。共检测了 84 名阳性和 16 名阴性 HCW。还根据症状后天数(DPS)将数据分为三组进行分析:<30(n=26),30-59(n=42)和>59(n=16)。Bioclin、Wondfo 和 Livzon 的观察敏感性分别为 85.71%、47.62%和 44.05%,所有 LFIA 的特异性均为 100%。Bioclin 更敏感(p<0.01),与 DPS 无关。因此,Bioclin 可用作 HCW 监测 SARS-CoV-2 血清转换的 POC 检测。