Abstract
ObjectivesDetermine the diagnostic accuracy of two antigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 at the point of care and define individuals’ characteristics providing best performance.MethodsWe performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs.ResultsBetween October 9th and 23rd, 2020, 1064 participants were enrolled. The PanbioTM Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1–5 days post symptom onset, combined Ag-RDT sensitivity was above 95%. Lower sensitivity of 88.2% was seen on the same day of symptom development (day 0).ConclusionsWe provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.
Highlights
The Coronavirus Disease 19 (COVID-19) pandemic, caused by SARS-CoV-2, has led to an unprecedented public health crisis
The PanbioTM Covid19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive AgRDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5%
We provide an independent validation of two widely available commercial Antigen-detecting rapid diagnostic tests (Ag-RDT), both meeting World Health Organization (WHO) criteria of 80% sensitivity and 97% specificity
Summary
The Coronavirus Disease 19 (COVID-19) pandemic, caused by SARS-CoV-2, has led to an unprecedented public health crisis. While RT-PCR based assays remain the standard for the detection of emerging respiratory viruses [1, 2], the need for high through-put virus detection has fueled development of Antigen-detecting rapid diagnostic tests (Ag-RDT), that can be performed at the point of care (POC) [3]. Such laboratory-independent tests could allow for control of the pandemic by quickly isolating individuals during their contagious period to prevent further transmission. Lambert-Niclot et al found a sensitivity of 50.0% with RDT NPS (Respi-Strip) versus PCR and for the CT value
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