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

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%

SUBMITTER: Giberti I 

PROVIDER: S-EPMC9312898 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature