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Sensitivities and specificities of Anti-SARS CoV2 detection kits - comparison and agreement between fifteen assays
Japanese Journal of Infectious Diseases ( IF 2.2 ) Pub Date : 2021-05-31 , DOI: 10.7883/yoken.jjid.2021.031
Fatima Kanani 1 , Saba Jamal 2 , Saira Khowaja 3 , Bushra Kaleem 4 , Sabiha Anis 5 , Sundus Iftikhar 4 , Nazia Khursheed 6 , Naila Baig Ansari 4
Affiliation  

The correct and rapid diagnosis of COVID-19 is vital for proper care and identification of affected individuals. This led to the early availability of many serological assays in the market but with limited validations. This study aimed to assess the validation of the serological assays based on different techniques. We evaluated fifteen assays based on four different immunoassay techniques on 235 patients. The most sensitive kit employing different techniques were as follows: immunochromatography (Zybio SARS CoV-2 IgM/IgG Antibody Assay Kit: 83%), ELISA (Aeskulisa SARS-CoV-2 NP IgG –88.1%), chemiluminescence (Alinity SARS-CoV-2 IgG – 82.2%) and immunofluorescence (Lifotronic FA160 [Shenzhen SARS-CoV-2 Assay Kit (IgG)] –88.9%). 100% specificity was seen in kits by Uniper (Singuway Biotec COVID-19 IgM/IgG Presumptive Kit), Genrui 2019-nCoV IgM/IgG Test Kit, Wondfu SARS CoV-2 Antibody Test and Aeskulisa SARS-CoV-2 NP IgG while IgG assay on Lifotronic FA160 (Shenzhen SARS-CoV-2 Assay Kit) showed the lowest specificity at 58%. Maximum agreement was observed between Aeskulisa SARS-CoV-2 NP IgG and Alinity SARS-CoV-2 IgG at 94%. Serological tests are practical alternatives but their reliability requires critical validation. The pandemic pointed a need for investment in health research on both national and international levels.



中文翻译:

抗 SARS CoV2 检测试剂盒的敏感性和特异性 - 十五种检测方法之间的比较和一致性

COVID-19 的正确和快速诊断对于正确护理和识别受影响的个体至关重要。这导致市场上许多血清学检测的早期可用性,但验证有限。本研究旨在评估基于不同技术的血清学检测的有效性。我们基于四种不同的免疫分析技术对 235 名患者评估了 15 种分析方法。采用不同技术的最敏感试剂盒如下:免疫层析(Zybio SARS CoV-2 IgM/IgG 抗体检测试剂盒:83%)、ELISA(Aeskulisa SARS-CoV-2 NP IgG –88.1%)、化学发光(Alinity SARS-CoV -2 IgG – 82.2%)和免疫荧光(Lifotronic FA160 [Shenzhen SARS-CoV-2 Assay Kit (IgG)] –88.9%)。Uniper 的试剂盒(Singuway Biotec COVID-19 IgM/IgG 推定试剂盒)具有 100% 的特异性,Genrui 2019-nCoV IgM/IgG 检测试剂盒、Wondfu SARS CoV-2 抗体检测和 Aeskulisa SARS-CoV-2 NP IgG,而 Lifotronic FA160(深圳 SARS-CoV-2 检测试剂盒)的 IgG 检测特异性最低,为 58%。Aeskulisa SARS-CoV-2 NP IgG 和 Alinity SARS-CoV-2 IgG 之间的最大一致性为 94%。血清学测试是实用的替代方法,但其可靠性需要严格验证。大流行表明需要在国家和国际层面对健康研究进行投资。血清学测试是实用的替代方法,但其可靠性需要严格验证。大流行表明需要在国家和国际层面对健康研究进行投资。血清学测试是实用的替代方法,但其可靠性需要严格验证。大流行表明需要在国家和国际层面对健康研究进行投资。

更新日期:2021-05-30
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