Open AccessEfficacy of Fluorecare SARS-CoV-2 Spike Protein Test Kit for SARS-CoV-2 detection in nasopharyngeal samples of 121 individuals working in a manufacturing company
Author(s) -
Valentina Tonelotto,
Annamaria Davini,
Laura Cardarelli,
Milena Calderone,
P Marin
Publication year - 2022
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0262174
Subject(s) - covid-19 , medicine , spike protein , point of care testing , virology , immunology , infectious disease (medical specialty) , outbreak , disease
Objectives The aim of this study was to evaluate the clinical performance of the Fluorecare SARS-CoV-2 Spike Protein Test Kit, a rapid immunochromatographic assay for SARS-CoV-2 detection. Moreover, we sought to point out the strategy adopted by a local company to lift the lockdown without leading to an increase in the number of COVID-19 cases, by performing a precise and timely health surveillance. Methods The rapid Fluorecare SARS-CoV-2 Spike Protein Test was performed immediately after sampling following the manufacturer’s instructions. RT-PCRs were performed within 24 hours of specimen collection. A total amount of 253 nasopharyngeal samples from 121 individuals were collected between March 16 and April 2, 2021 and tested. Results Of 253 nasopharyngeal samples, 11 (9.1%) were positive and 242 (90.9%) were negative for SARS-CoV-2 RNA by RT-PCR assays. The rapid SARS-CoV-2 antigen detection test’s mean sensitivity and specificity were 84,6% (95% CI, 54.6–98.1%) and 100% (95% CI, 98.6–100%), respectively. Two false negative test results were obtained from samples with high RT-PCR cycle threshold (Ct). Conclusion Our study suggested that Fluorecare SARS-CoV-2 Spike Protein Test can be introduced into daily diagnostic practice, as its mean sensitivity and specificity follow the standards recommended by WHO and IFCC Task Force. In addition, we underlined how the strategy adopted by a local company to risk assessment and health surveillance was appropriate for infection containment. This real-life scenario gave us the possibility to experience potential approaches aimed to preserve public health and work activities.