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

• Published in: International journal of infectious diseases Vol. 112; pp. 281 - 287
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.11.2021; Published by Elsevier Ltd on behalf of International Society for Infectious Diseases; Elsevier
• Subjects: Academies and Institutes; Antibodies, Viral; antibody; COVID-19; Diagnostic Tests, Routine; Humans; Immunoglobulin M; Rapid diagnostic test; SARS-CoV-2; Sensitivity and Specificity; serological reference panel; Uganda - epidemiology; Uganda; COVID-19; Rapid diagnostic test; SARS-CoV-2; antibody; performance; serological reference panel
• ISSN: 1201-9712; 1878-3511
• DOI: 10.1016/j.ijid.2021.09.020

●This study identified the best performing rapid diagnostic kits for the detection of COVID-19 antibodies.●A characterized reference panel of specimens was used to evaluate the serological kits.●For IgM/IgG, Autobio, MultiG, and Standard Q had sensitivity and specificity ≥98%.●For IgG, Boson, MultiG, Standard Q, and VivaDiag had sensitivity and specificity ≥98%.●Serological testing will help better understand the epidemiology of the virus. 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. 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. 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. 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.