SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers

viromed rapid test for the detection of sars-cov-2

viromed rapid test for the detection of sars-cov-2

Abstract

Objectives

Determine 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.

Methods

We performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs.

Results

Between 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).

Conclusions

We 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.

viromed rapid test for the detection of sars-cov-2
viromed rapid test for the detection of sars-cov-2

Introduction

The Coronavirus Disease 19 (COVID-19) pandemic, caused by SARS-CoV-2, has led to an unprecedented public health crisis. Diagnostic strategies that are low cost, rapid, and easily accessible are critical to control the pandemic. 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. These tests can affordably help overcome overwhelmed diagnostic laboratories and global PCR-reagent shortages [4, 5]. Given that viral load, as measured by RNA copies, peaks near symptom onset [6–8] and contagiousness begins even earlier [9, 10], RDTs may have the highest sensitivity (SN) in the most contagious individuals. Reported SNs of Ag-RDTs vary widely, and manufacturer reported SNs are often substantially higher than those of independent assessments [11]. Previous studies with NPS rapid antigenic tests (Panbio) for detection of SARS-CoV-2 shows the sensitivity of 95% for Ct ≤25, and 85% for Ct <30 in symptomatic patients and the sensitivity near of 80% for a period of less than 7 days from symptom onset but the overall sensitivity in this population seems low at 67.3% [12]. A study on two NPS RDT (Panbio and SD Biosensor) versus PCR in symptomatic population found an overall sensitivity of 73.8% and 68.5%; for a CT value< 30, sensitivities of two RDT are respectively 87% and 81.4% in a population with mostly symptomatic patients [13]. Lambert-Niclot et al. found a sensitivity of 50.0% with RDT NPS (Respi-Strip) versus PCR and for the CT value <25CT, sensitivity was 82.2% [14].

The World Health Organization’s (WHO) Ag-RDT target product profile aims at SNs ≥80% and specificities (SP) of ≥97% [5, 15]. Thus, we sought to evaluate the performance of two commercially available Ag-RDTs through a prospective, single-center POC validation in comparison to RT-PCR for detecting SARS-CoV-2 using nasopharyngeal swabs (NPS). We evaluate also the performance of these tests according to the duration of symptoms and viral loads of patients mostly symptomatic.

 

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