Evaluation of the performance of 25 SARS-CoV-2 serological rapid diagnostic tests using a reference panel of plasma specimens at the Uganda Virus Research Institute

Lutalo, T. et al. (2021) Evaluation of the performance of 25 SARS-CoV-2 serological rapid diagnostic tests using a reference panel of plasma specimens at the Uganda Virus Research Institute. International Journal of Infectious Diseases, 112, pp. 281-287. (doi: 10.1016/j.ijid.2021.09.020) (PMID:34536612) (PMCID:PMC8442260)

Abstract

Introduction: Serological testing is needed to better understand the epidemiology of the SARS-CoV-2 virus. Rapid Diagnostic Tests (RDTs) have been developed to detect specific antibodies, IgM and IgG, to the virus. We evaluated the performance of 25 of these RDTs. Methods: A serological reference panel of 50 positive and 100 negative plasma specimens was developed from SARS-CoV-2 PCR and antibody positive patients and pre-pandemic SARS-CoV-2-negative specimens collected in 2016. Test performance of the 25 RDTs was evaluated against this panel. Results: A total of 10 RDTs had a sensitivity ≥98% while 13 RDTs had a specificity ≥98% to anti-SARS-CoV-2 IgG antibodies. Four RDTs; Boson, MultiG, Standard Q and ViviaDiag had both sensitivity and specificity of ≥98% to anti-SARS-CoV-2 IgG antibodies. Only 3 RDTs had a sensitivity ≥98% while 10 RDTs had a specificity ≥98% to anti-SARS-CoV-2 IgM antibodies. Three RDTs; Autobio, MultiG and Standard Q, had sensitivity and specificity of ≥98% to combined IgG/IgM. The RDTs that performed well also had perfect or almost perfect inter-reader agreement. Conclusions: This evaluation identified three RDTs with a sensitivity and specificity to IgM/IgG antibodies of ≥98% with the potential for widespread antibody testing in Uganda.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Cotten, Professor Matthew
• Authors: Lutalo, T., Nalumansi, A., Olara, D., Kayiwa, J., Ogwang, B., Odwilo, E., Watera, C., Balinandi, S., Kiconco, J., Nakaseegu, J., Serwanga, J., Kikaire, B., Ssemwanga, D., Abiko, B., Nsereko, C., Cotten, M., Buule, J., Lutwama, J., Downing, R., and Kaleebu, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity; College of Medical Veterinary and Life Sciences > School of Infection & Immunity > Centre for Virus Research
• Journal Name: International Journal of Infectious Diseases
• Publisher: Elsevier
• ISSN: 1201-9712
• ISSN (Online): 1878-3511
• Published Online: 15 September 2021
• Copyright Holders: Copyright © 2021 Crown Copyright
• First Published: First published in International Journal of Infectious Diseases 112: 281-287
• Publisher Policy: Reproduced under a Creative Commons License