Performance and operational feasibility of antigen and antibody rapid diagnostic tests for COV-19 in symptomatic and asymptomatic patients in Cameroon: a clinical, prospective, diagnostic accuracy study
March 25, 2021
Yap Boum, Karl Njuwa Fai, Birgit Nicolay, Akenji Blaise Mboringong, Lisa M Bebell, Mark Ndifon, Aristide Abbah, Rachel Essaka, Lucrèce Eteki, Francisco Luquero, Céline Langendorf, Nicole Fouda Mbarga, Rene Ghislain Essomba, Bongkiyung Donald Buri, Tchoula Mamiafo Corine, Bertrand Tchualeu Kameni, Nadia Mandeng, Mahamat Fanne, Anne-Cécile Zoung-Kani Bisseck, Clement B Ndongmo, Sara Eyangoh, Achta Hamadou, Jean Patrick Ouamba, Modeste Tamakloé Koku, Richard Njouom, Okomo Marie Claire, Linda Esso, Emilienne Epée, Georges Alain Etoundi Mballa
The Lancet Infectious Diseases
Boum et al. conducted a prospective, diagnostic accuracy study to evaluate the performance of four antibody-based rapid diagnostic tests (Innovita [Biological Technology; Beijing, China], Wondfo [Guangzhou Wondfo Biotech; Guangzhou, China], SD Biosensor [SD Biosensor; Gyeonggi-do, South Korea], and Runkun tests [Runkun Pharmaceutical; Hunan, China], and one antigen-based rapid diagnostic test (SD Biosensor [SD Biosensor; Gyeonggi-do, South Korea]) for community-based detection of SARS-CoV-2 infection in Cameroon. A total 1,195 participants were enrolled in the study between June 2nd and August 30th, 2020. Participants were either symptomatic with suspected COVID-19 or already began treatment (570 participants) or asymptomatic but presenting for screening voluntarily or from a contact tracing referral (625 participants). Antigen rapid diagnostic tests were compared with Abbot PCR testing and antibody rapid diagnostic tests were compared with Biomerieux immunoassays. Within the first seven days of symptom onset, antigen tests performed well, with a sensitivity of 80.0%. Antibody tests demonstrated low sensitivity (26.8%) during the first week of symptoms with sensitivity increasing to 76.4% 14 days after symptoms onset. For asymptomatic patients, sensitivity was 37.0% for antigen tests and 50.7% for antibody tests. A retrospective antigen-based algorithm demonstrated 94% sensitivity and 91% specificity among symptomatic patients and 34.0% sensitivity and 92.0% specificity among asymptomatic patients. These findings demonstrate the value of rapid diagnostics with testing algorithms as alternatives to PCR.
Boum Y, Fai KN, Nicolay B, et al. Performance and operational feasibility of antigen and antibody rapid diagnostic tests for COVID-19 in symptomatic and asymptomatic patients in Cameroon: a clinical, prospective, diagnostic accuracy study. Lancet Infect Dis 2021; 0. DOI:10.1016/S1473-3099(21)00132-8.