期刊
BIOMEDICINES
卷 10, 期 9, 页码 -出版社
MDPI
DOI: 10.3390/biomedicines10092327
关键词
nasal swabs; self-collection; antigen rapid tests; clinical evaluation; resource-poor settings
资金
- World Health Organization
- Global Affairs Canada [P009134]
- Bill and Melinda Gates Foundation [OPP1214435]
- Bill and Melinda Gates Foundation [OPP1214435] Funding Source: Bill and Melinda Gates Foundation
This study evaluated the performance of nasal swabs for SARS-CoV-2 detection in resource-poor settings and assessed the clinical performance of three nasal swab-based antigen rapid tests. The results showed that nasal swabs had slightly lower sensitivity compared to oropharyngeal swabs, and the COVIOS Ag-RDT did not meet the requirements set by the WHO. Nasal swab-based antigen rapid tests are a viable and accurate diagnostic option in resource-poor settings.
Background: In resource-poor countries, antigen-based rapid tests (Ag-RDTs) performed at primary healthcare and community settings improved access to SARS-CoV-2 diagnostics. However, the technical skills and biosafety requirements inherent to nasopharyngeal and oropharyngeal (OP) specimens limit the scale-up of SARS-CoV-2 testing. The collection of nasal-swabs is programmatically viable, but its performance has not been evaluated in resource-poor settings. Methods: We first evaluated the performance of SteriPack self-collected nasal swabs for the detection of SARS-CoV-2 by real-time PCR in 1498 consecutively enrolled patients with suspected infection. Next, we evaluated the clinical performance of three nasal swab-based Ag-RDTs against real-time PCR on OP specimens. Results: The sensitivity of nasal swabs was 80.6% [95% CI: 75.3-85.2%] compared to OP specimens. There was a good correlation (r = 0.58; p < 0.0001) between Ct values of 213 positive cases obtained using nasal and OP swabs. Our findings show sensitivities of 79.7% [95% CI: 73.3-85.1%] for Panbio COVID-19 Ag-RDT, 59.6% [95% CI: 55.2-63.8%] for COVIOS Ag-RDT, and 78.0% [95% CI: 73.5-82.0%] for the LumiraDx SARS-CoV-2 Ag-RDT. Conclusions: In our setting, the COVIOS Ag-RDT did not meet WHO requirements. Nasal swab-based Ag-RDTs for SARS-CoV-2 detection constitute a viable and accurate diagnostic option in resource-poor settings.
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