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, Tom; Nalumansi, Aminah; Olara, Denis; Kayiwa, John; 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; Downing, Robert; Kaleebu, Pontiano

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.