Sensitivities and specificities of Anti-SARS CoV2 detection kits - comparison and agreement between fifteen assays.

Kanani, Fatima; Jamal, Saba; Khowaja, Saira; Kaleem, Bushra; Anis, Sabiha; Iftikhar, Sundus; Khursheed, Nazia; Ansari, Naila Baig

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.