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

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

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.

Highlights

Introduction(SARS-CoV-2) is the high rate of undocumented and asymptomatic cases which are able to spread the infection silently in the community [1]
One reason behind the explosive spread of the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) is the high rate of undocumented and asymptomatic cases which are able to spread the infection silently in the community [1]
reverse transcriptase polymerase chain reaction (RT-PCR), it cannot be used as a POCT and requires well-trained clinical laboratory staff and special tools to RT-PCR, it cannot be used as a POCT and requires well-trained clinical laboratory staff and special and equipment to be performed

Summary

Introduction

(SARS-CoV-2) is the high rate of undocumented and asymptomatic cases which are able to spread the infection silently in the community [1]. Real-time reverse transcriptase polymerase chain reaction (RT-PCR) is used as a standard method for SARS-CoV-2 diagnosis [2]. RT-PCR tests have many limitations including long turnaround time (~8–10 h), high cost, and the need for specified machines and highly skilled personnel. RT-PCR can provide false negative results due to several reasons such as the timing as well as the quality of the collected swab samples, especially that the viral load declines in the upper respiratory tract with time [3,4]. RT-PCR is only valid for patients with active shedding of infectious viruses or viral RNA and does not provide any data on the patients’ immune status

Objectives

Methods

Conclusion