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

• Published in: Biomedicines Vol. 10; no. 7; p. 1558
• Main Authors: Giberti, Irene, Costa, Elisabetta, Domnich, Alexander, Ricucci, Valentina, De Pace, Vanessa, Garzillo, Giada, Guarona, Giulia, Icardi, Giancarlo
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 30.06.2022; MDPI
• Subjects: Accuracy; Antigens; Coronaviruses; COVID-19; diagnostic accuracy; Laboratories; lateral flow test; Public health; rapid antigen detection test; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; validation study; United States > US; Italy; South Korea; COVID-19; SARS-CoV-2; diagnostic accuracy; rapid antigen detection test; validation study; lateral flow test
• ISSN: 2227-9059; 2227-9059
• DOI: 10.3390/biomedicines10071558

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.