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. 2021 Nov:112:281-287.
doi: 10.1016/j.ijid.2021.09.020. Epub 2021 Sep 15.

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

Tom Lutalo  1 , Aminah Nalumansi  1 , Denis Olara  1 , John Kayiwa  1 , Bernard Ogwang  1 , Emmanuel Odwilo  1 , Christine Watera  1 , Stephen Balinandi  1 , Jocelyn Kiconco  1 , Joweria Nakaseegu  1 , Jennifer Serwanga  2 , Bernard Kikaire  1 , Deogratius Ssemwanga  2 , Brendah Abiko  1 , Christopher Nsereko  3 , Matthew Cotten  4 , Joshua Buule  1 , Julius Lutwama  1 , Robert Downing  1 , Pontiano Kaleebu  5
Affiliations

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

Tom Lutalo et al. Int J Infect Dis. 2021 Nov.

Abstract

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.

Keywords: COVID-19; Rapid diagnostic test; SARS-CoV-2; antibody; performance; serological reference panel.

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