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High Diagnostic Accuracy of a Novel Lateral Flow Assay for the Point-of-Care Detection of SARS-CoV-2
| Content Provider | MDPI |
|---|---|
| Author | Giberti, Irene Costa, Elisabetta Domnich, Alexander Ricucci, Valentina Pace, Vanessa De Garzillo, Giada Guarona, Giulia Icardi, Giancarlo |
| Copyright Year | 2022 |
| Description | 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 3.95 × $10^{6}$ copies/mL) and ≥30 (≤1.29 × $10^{5}$ copies/mL) were 100% and 50%, respectively. The performance was maximized in testing samples with viral loads ≥1.29 × $10^{5}$ 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. |
| Starting Page | 1558 |
| e-ISSN | 22279059 |
| DOI | 10.3390/biomedicines10071558 |
| Journal | Biomedicines |
| Issue Number | 7 |
| Volume Number | 10 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2022-06-30 |
| Access Restriction | Open |
| Subject Keyword | Biomedicines Microbiology Sars-cov-2 Covid-19 Lateral Flow Test Rapid Antigen Detection Test Diagnostic Accuracy Validation Study |
| Content Type | Text |
| Resource Type | Article |
