巴西 100 名医护人员的研究数据:三种即时侧向流动免疫分析法检测抗 SARS-CoV-2 抗体的比较分析。

Comparative analysis of three point-of-care lateral flow immunoassays for detection of anti-SARS-CoV-2 antibodies: data from 100 healthcare workers in Brazil.

机构信息

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.

出版信息

Braz J Microbiol. 2021 Sep;52(3):1161-1165. doi: 10.1007/s42770-021-00498-z. Epub 2021 Apr 19.

Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a787/8324714/8dc341c95832/42770_2021_498_Fig1_HTML.jpg

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