Validation and performance comparison of two SARS-CoV-2 IgG/IgM rapid tests

Nisreen Naser Al Awaji; Hanadi Talal Ahmedah; Isra Mohammed Alsaady; Rowaedh Ahmed Bawaked; Mohammed A Alraey; Ahmed Ayed Alasiri; Abdullah Mofareh Alfaifi; Hamdan Ali Alshehri; Raed Alserihi; Elrashed B Yasin

doi:10.1016/j.sjbs.2021.03.007

Validation and performance comparison of two SARS-CoV-2 IgG/IgM rapid tests

Saudi J Biol Sci. 2021 Jun;28(6):3433-3437. doi: 10.1016/j.sjbs.2021.03.007. Epub 2021 Mar 14.

Affiliations

¹ Department of Health Communication Sciences, College of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, P.O Box 84428, Riyadh 11671, Saudi Arabia.
² Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Rabegh, Saudi Arabia.
³ Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.
⁴ Special Infectuis Agent unit, King Fahad Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia.
⁵ Centre of Excellence in Genomic Medicine Research, King Abdulaziz University, Jeddah, Saudi Arabia.
⁶ Infection Prevention and Control Department, King Abdullah bin Abdulaziz University Hospital, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.
⁷ Department of Pathology and Laboratory Medicine, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia.
⁸ Department of Pathology and Laboratory Medicine, King Abdullah Bin Abdulaziz University Hospital, Riyadh, Saudi Arabia.
⁹ Department of Pathology and Clinical Laboratory, King Abdullah Bin Abdulaziz University Hospital, Riyadh, Saudi Arabia.
¹⁰ Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Rabigh, Saudi Arabia.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a disease called COVID-19. COVID-19 is primarily diagnosed using molecular techniques mainly real-time reverse transcriptase PCR. Reliable and accurate serologic assays for COVID-19, are an important tool for surveillance and epidemiologic studies. In this study, the IgG/IgM Rapid Test Cassette and the Prima COVID-19 IgG/IgM Rapid Test for the detection of SARS-CoV-2 antibodies in blood, serum and plasma samples collected from patients up to 48 days after symptom onset in Saudi Arabia were validated. Overall, both tests showed poor performance and cannot be utilised for COVID-19 diagnosis as a point of care test or to determine seroprevalence.

Keywords: COVID-19; COVID-19 rapid test; COVID-19, Coronavirus disease 2019; RT-PCR, real-time reverse transcription-polymerase chain reaction; SARS-CoV, severe acute respiratory syndrome coronavirus; SARS-CoV-2 IgG; SARS-CoV-2 IgM; SARS-CoV-2 antibodies; Serological test for COVID-19.