J Hosp Infect. 2022 Feb 21:S0195-6701(22)00059-7. doi: 10.1016/j.jhin.2022.02.009. Online ahead of print.
In this study we performed a systematic literature review and meta-analysis of the lateral flow-based FebriDx immunoassay for triaging patients with suspected coronavirus disease 2019 (COVID-19) upon healthcare facilities admission. We conducted an electronic search in Scopus and Medline with the keywords "FebriDx" AND "COVID-19" OR "SARS-CoV-2", with no language or date (i.e., up to February 4, 2022) limits, selecting studies where FebriDx was used for triaging patients for suspected COVID-19 in acute care settings, reporting sufficient data for constructing a 2×2 table. Five studies were finally included in our analysis, totalling 2309 patients. The pooled diagnostic sensitivity and specificity were 0.91 (95%CI, 0.88-0.93) and 0.92 (95%CI, 0.90-0.93), whilst the area under the curve (AUC), accuracy and kappa statistics were 0.971 (95%CI, 0.962-0.980), 91.4% (95%CI, 90.2-92.5%) and 0.762 (95%CI, 0.731-0.793), respectively, thus reflecting a substantial agreement with reference molecular testing techniques. The negative (NPV) and positive (PPV) predictive values were 0.974 (95%CI, 0.966-0.981) and 0.742 (95%CI, 0.711-0.770), respectively. In conclusion, our pooled analysis demonstrates that FebriDx has clinical value for rapid screening of patients with suspected COVID-19 in acute care settings, especially in regions with high viral circulation in which the pre-test probability is high and enables prioritization for confirmatory laboratory testing.