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. 2022 Jun 30;10(7):1558.
doi: 10.3390/biomedicines10071558.

High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2

Irene Giberti  1 , Elisabetta Costa  1 , Alexander Domnich  2 , Valentina Ricucci  2 , Vanessa De Pace  2 , Giada Garzillo  1 , Giulia Guarona  2 , Giancarlo Icardi  1   2
Affiliations

High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2

Irene Giberti et al. Biomedicines. .

Abstract

Highly accurate lateral flow immunochromatographic tests (LFTs) are an important public health tool to tackle the ongoing COVID-19 pandemic. The aim of this study was to assess the comparative diagnostic performance of the novel ND COVID-19 LFT under real-world conditions. A total of 400 nasopharyngeal swab specimens with a wide range of viral loads were tested in both reverse-transcription polymerase chain reaction and ND LFT. The overall sensitivity and specificity were 85% (95% CI: 76.7−90.7%) and 100% (95% CI: 98.7−100%), respectively. There was a clear association between the false-negative rate and sample viral load: the sensitivity parameters for specimens with cycle threshold values of <25 (>3.95 × 106 copies/mL) and ≥30 (≤1.29 × 105 copies/mL) were 100% and 50%, respectively. The performance was maximized in testing samples with viral loads ≥1.29 × 105 copies/mL. These findings suggest that the ND LFT is sufficiently accurate and useful for mass population screening programs, especially in high-prevalence and resource-constrained settings or during periods when the epidemic curve is rising. Other public health implications were also discussed.

Keywords: COVID-19; SARS-CoV-2; diagnostic accuracy; lateral flow test; rapid antigen detection test; validation study.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Distribution of true positive and false-negative samples, by viral load.
See this image and copyright information in PMC

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