@article{Lutalo_T-2021_47018,
title = {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},
author = {Lutalo, T. and Nalumansi, A. and Olara, D. and Kayiwa, J. and Ogwang, B. and Odwilo, E. and Watera, C. and Balinandi, S. and Kiconco, J. and Nakaseegu, J. and Serwanga, J. and Kikaire, B. and Ssemwanga, D. and Abiko, B. and Nsereko, C. and Cotten, M. and Buule, J. and Lutwama, J. and Downing, R. and Kaleebu, P.},
month = {sep},
year = {2021},
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.},
pages = {281-287},
volume = {112},
journal = {International Journal of Infectious Diseases},
publisher = {Elsevier},
url = {http://dx.doi.org/10.1016/j.ijid.2021.09.020},
}
