TY - JOUR
AU - Lutalo, Tom
AU - Nalumansi, Aminah
AU - Olara, Denis
AU - Kayiwa, John T.
AU - Ogwang, Bernard
AU - Odwilo, Emmanuel
AU - Watera, Christine
AU - Balinandi, Stephen
AU - Kiconco, Jocelyn
AU - Nakaseegu, Joweria
AU - Serwanga, Jennifer
AU - Kikaire, Bernard
AU - Ssemwanga, Deogratius
AU - Abiko, Brendah
AU - Nsereko, Christopher
AU - Cotten, Matthew
AU - Buule, Joshua
AU - Lutwama, Julius J.
AU - Downing, Robert
AU - Kaleebu, Pontiano
PY - 2021
DA - September
TI - 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
JO - International Journal of Infectious Diseases
EP - 287
VL - 112
DO - http://dx.doi.org/10.1016/j.ijid.2021.09.020
AB - 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.
PB - Elsevier
UR - http://eprints.gla.ac.uk/254078/
KW - Coronavirus (COVID-19)
ER