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.
【저자키워드】 COVID-19, SARS-CoV-2, antibody, Rapid diagnostic test, performance, serological reference panel., 【초록키워드】 antibodies, Uganda, Antibody testing, coronavirus, antibody, Epidemiology, diagnostic test, Test, diagnostic, severe acute respiratory syndrome Coronavirus, virus, sensitivity, specificity, Serological testing, Sensitivity and specificity, RDT, Rapid diagnostic test, IgG antibodies, IgM antibodies, anti-SARS-CoV-2 IgG, IgM/IgG, diagnostic tests, anti-SARS-CoV-2 IgG antibodies, Rapid, plasma, respiratory, serological, anti-SARS-CoV-2 IgM, specific antibodies, RDTs, SARS-CoV-2 PCR, IgM and IgG, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, specimen, positive patients, positive, Standard Q, Boson, widespread, performed, detect, collected, evaluated, positive patient, reference panel, 【제목키워드】 plasma, serological, specimen, reference panel,