Evaluation of the performance of Abbott Panbio™ COVID-19 antigen rapid diagnostic test for the detection of severe acute respiratory syndrome coronavirus 2 at Harar, Eastern Ethiopia

Zelalem Teklemariam; Dereje Feleke; Abdusemed Abdurahman; Astawus Alemayehu; Abebaw Demissie; Asefa Tufa; Nebiyu Sherefa; Abdusemed Mohammed; Mussie Brhane; Kasahun Bogale

doi:10.3389/fmed.2023.1135027

Evaluation of the performance of Abbott Panbio™ COVID-19 antigen rapid diagnostic test for the detection of severe acute respiratory syndrome coronavirus 2 at Harar, Eastern Ethiopia

Front Med (Lausanne). 2023 May 31:10:1135027. doi: 10.3389/fmed.2023.1135027. eCollection 2023.

Authors

Affiliations

¹ School of Medical Laboratory Sciences, College Health and Medical Sciences, Haramaya University, Harar, Ethiopia.
² Department of Health Informatics, Harar Health Science College, Harar, Ethiopia.
³ Harari Health Research and Regional Laboratory, Department of Microbiology, Harar, Ethiopia.
⁴ Department of Public Health, Harar Health Science College, Harar, Ethiopia.
⁵ Department of Anesthesia, Harar Health Science College, Harar, Ethiopia.
⁶ Department of Field Epidemiology, Harari Regional Health Bureau, Harar, Ethiopia.
⁷ Department of Health Economics, Harari Regional Health Bureau, Harar, Ethiopia.
⁸ Department of Midwifery, Harar Health Science College, Harar, Ethiopia.
⁹ Hararghe Health Research Laboratory, Haramaya University, Harar, Ethiopia.
¹⁰ School of Medical Laboratory Sciences, College of Health and Medical Science, Haramaya University, Harar, Ethiopia.

Abstract

Background: Rapid antigen tests can help in the effective isolation of symptomatic cases and the systematic tracing of close contacts. However, their reliability must be validated before implementing them widely.

Methods: A cross-sectional study was conducted on 236 COVID-19-suspected patients visiting four different health institutions in Harari Regional State, Harar, Eastern Ethiopia, from June to July 2021. Two nasopharyngeal samples were collected and processed by the Panbio™ Ag-RDT kit and qRT-PCR. The collected data were analyzed using SPSS version 25.0.

Results: The Panbio tests had a sensitivity of 77.5% (95% CI: 61.6-89.2%) and a specificity of 98.5% (95% CI: 95.6-99.7%). It also had a positive predictive value of 91.2% (95% CI: 76.9-96.9%), a negative predictive value of 95.5% (95% CI: 92.3-97.4%), and a kappa of 0.81 (95% CI: 0.7-0.9). The test had a sensitivity of 94.4%, 100%, 100%, and 90% in the samples collected from patients within the 1-5 days post-onset of COVID-19 signs and symptoms, of age group ≤18 years old, with cycle threshold values of <20, and with household contact, respectively.

Conclusion: This test can be used as point-of-care testing for the diagnosis of symptomatic patients with short clinical courses and contact with patients in households.

Keywords: Eastern Ethiopia; Harar; Panbio™; RT-PCR; Rapid diagnostic test; SARS-CoV-2; sensitivity; specificity.