tetano
Editor, Senior Moderator
Pathogens
. 2020 Dec 19;9(12):E1067.
doi: 10.3390/pathogens9121067.
Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
Anwar M Hashem[SUP] 1 2 [/SUP], Rowa Y Alhabbab[SUP] 1 3 [/SUP], Abdullah Algaissi[SUP] 4 5 [/SUP], Mohamed A Alfaleh[SUP] 1 6 [/SUP], Sharif Hala[SUP] 7 8 [/SUP], Turki S Abujamel[SUP] 1 3 [/SUP], M-Zaki ElAssouli[SUP] 1 [/SUP], Afrah A Al-Somali[SUP] 9 [/SUP], Fadwa S Alofi[SUP] 10 [/SUP], Asim A Khogeer[SUP] 11 [/SUP], Almohanad A Alkayyal[SUP] 12 [/SUP], Ahmad Bakur Mahmoud[SUP] 13 [/SUP], Naif A M Almontashiri[SUP] 13 14 [/SUP], Arnab Pain[SUP] 7 15 16 [/SUP]
Affiliations
Abstract
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.
Keywords: COVID-19; SARS-CoV-2; antibodies; rapid assay; serology.
. 2020 Dec 19;9(12):E1067.
doi: 10.3390/pathogens9121067.
Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
Anwar M Hashem[SUP] 1 2 [/SUP], Rowa Y Alhabbab[SUP] 1 3 [/SUP], Abdullah Algaissi[SUP] 4 5 [/SUP], Mohamed A Alfaleh[SUP] 1 6 [/SUP], Sharif Hala[SUP] 7 8 [/SUP], Turki S Abujamel[SUP] 1 3 [/SUP], M-Zaki ElAssouli[SUP] 1 [/SUP], Afrah A Al-Somali[SUP] 9 [/SUP], Fadwa S Alofi[SUP] 10 [/SUP], Asim A Khogeer[SUP] 11 [/SUP], Almohanad A Alkayyal[SUP] 12 [/SUP], Ahmad Bakur Mahmoud[SUP] 13 [/SUP], Naif A M Almontashiri[SUP] 13 14 [/SUP], Arnab Pain[SUP] 7 15 16 [/SUP]
Affiliations
- PMID: 33352788
- DOI: 10.3390/pathogens9121067
Abstract
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8-27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.
Keywords: COVID-19; SARS-CoV-2; antibodies; rapid assay; serology.