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

Authors: Lutalo, Tom;

Nalumansi, Aminah;

Olara, Denis;

Kayiwa, John T.;

Ogwang, Bernard;

Odwilo, Emmanuel;

Watera, Christine;

Balinandi, Stephen;

Kiconco, Jocelyn;

Nakaseegu, Joweria;

Serwanga, Jennifer ;

Kikaire, Bernard;

Ssemwanga, Deogratius;

Abiko, Brendah;

Nsereko, Christopher;

Cotten, Matthew ;

Buule, Joshua;

Lutwama, Julius J.;

Downing, Robert;

Kaleebu, Pontiano

Source: International Journal of Infectious Diseases

Full text

: http://dx.doi.org/10.1016/j.ijid.2021.09.020

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.

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Under a Creative Commons license https://creativecommons.org/licenses/by/4.0/

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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. & Kaleebu, P. 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. http://dx.doi.org/10.1016/j.ijid.2021.09.020

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DOI: http://dx.doi.org/10.1016/j.ijid.2021.09.020

Repository URI: http://eprints.gla.ac.uk/254078/