Clinical Evaluation of Severe Acute Respiratory Syndrome Coronavirus 2 Rapid Antigen Tests During the Omicron Wave in South Africa

Natasha Samsunder; Margaretha de Vos; Sinaye Ngcapu; Jennifer Giandhari; Lara Lewis; Ayesha B M Kharsany; Cherie Cawood; Tulio de Oliveira; Quarraisha Abdool Karim; Salim Abdool Karim; Kogieleum Naidoo; Camille Escadafal; Aida Sivro

doi:10.1093/infdis/jiac333

Clinical Evaluation of Severe Acute Respiratory Syndrome Coronavirus 2 Rapid Antigen Tests During the Omicron Wave in South Africa

J Infect Dis. 2022 Oct 17;226(8):1412-1417. doi: 10.1093/infdis/jiac333.

Authors

Natasha Samsunder¹, Margaretha de Vos², Sinaye Ngcapu^{1

3}, Jennifer Giandhari⁴, Lara Lewis¹, Ayesha B M Kharsany^{1

2}, Cherie Cawood⁵, Tulio de Oliveira^{1

4

6

7}, Quarraisha Abdool Karim^{1

8}, Salim Abdool Karim^{1

8}, Kogieleum Naidoo^{1

9}, Camille Escadafal², Aida Sivro^{1

3}

Affiliations

¹ Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
² FIND, the Global Alliance for Diagnostics, Geneva, Switzerland.
³ Department of Medical Microbiology, University of KwaZulu-Natal, Durban, South Africa.
⁴ KwaZulu-Natal Research Innovation and Sequencing Platform, Durban, South Africa.
⁵ Epicentre AIDS Risk Management, Durban, South Africa.
⁶ Centre for Epidemic Response and Innovation, School of Data Science and Computational Thinking, Stellenbosch University, Stellenbosch, South Africa.
⁷ Department of Global Health, University of Washington, Seattle, USA.
⁸ Department of Epidemiology, Columbia University, New York City, USA.
⁹ MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.

Abstract

We evaluated the performance of nasal and nasopharyngeal Standard Q COVID-19 [coronavirus disease 2019] Ag tests (SD Biosensor) and the Panbio COVID-19 Ag Rapid Test Device (nasal; Abbott) against the Abbott RealTime severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay during the Omicron (clades 21M, 21K, and 21L) wave in South Africa. Overall, all evaluated tests performed well, with high sensitivity (range, 77.78%-81.42%) and excellent specificity values (>99%). The sensitivity of rapid antigen tests increased above 90% in samples with cycle threshold <20, and all 3 tests performed best within the first week after symptom onset.

Keywords: 21K/BA1; 21L/BA2; COVID-19; Omicron; SARS-CoV-2; antigen; sensitivity; specificity.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antigens, Viral
COVID-19 Testing
COVID-19* / diagnosis
Humans
SARS-CoV-2*
Sensitivity and Specificity
South Africa

Substances

Antigens, Viral