Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies.

Anwar M Hashem, Rowa Y Alhabbab, Abdullah Algaissi, Mohamed A Alfaleh, Sharif Hala, Turki S Abujamel, M-Zaki ElAssouli, Afrah A AL-Somali, Fadwa S Alofi, Asim A Khogeer, Almohanad A Alkayyal, Ahmad Bakur Mahmoud, Naif A M Almontashiri, Arnab Pain

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish (US)
Pages (from-to)1067
JournalPathogens (Basel, Switzerland)
Volume9
Issue number12
DOIs
StatePublished - Dec 23 2020

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