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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

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...

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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8442260/
https://www.ncbi.nlm.nih.gov/pubmed/34536612
http://dx.doi.org/10.1016/j.ijid.2021.09.020
Descripción
Sumario: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.