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; +10 more...Serwanga, JenniferORCID logo; Kikaire, Bernard; Ssemwanga, Deogratius; Abiko, Brendah; Nsereko, Christopher; Cotten, MatthewORCID logo; Buule, Joshua; Lutwama, Julius; Downing, Robert; and Kaleebu, PontianoORCID logo (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 : IJID : official publication of the International Society for Infectious Diseases, 112. pp. 281-287. ISSN 1201-9712 DOI: 10.1016/j.ijid.2021.09.020
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INTRODUCTION: Serological testing is needed to better understand the epidemiology of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Rapid diagnostic tests (RDTs) have been developed to detect specific antibodies, IgM and IgG, to the virus. The performance of 25 of these RDTs was evaluated. 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 VivaDiag) had both sensitivity and specificity ≥98% to anti-SARS-CoV-2 IgG antibodies. Only three 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 ≥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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