Rapid Antigen Test LumiraDxTM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study
International Journal of Environmental Research and Public Health
; 19(7):3826, 2022.
Article
in English
| MDPI | ID: covidwho-1762165
ABSTRACT
Background:
Real time reverse transcription polymerase chain reaction (real time RT-PCR) testing is the gold standard for the diagnosis of SARS-CoV-2 infections. However, to expand the testing capacity, new SARS-CoV-2 rapid antigen tests (Ag-RDTs) have been implemented. Ag-RDTs are more rapid, but less reliable in terms of sensitivity, and real-life data on their performance in comparison with the real time RT-PCR test are lacking.Methods:
We aimed at assessing the diagnostic performance of the third-generation antigenic swab LumiraDx™compared with real time RT-PCR in a retrospective cohort study at the Infectious Diseases Unit of Padua. All of the patients who were consecutively tested for SARS-CoV-2 in our centre (by both real time RT-PCR and Ag-RTD LumiraDxTM) from 19 January to 30 May 2021, were included. Cycle-threshold (Ct) values of positive real time RT-PCR were recorded as well as the number of days from symptoms' onset to testing.Results:
Among the 282 patients included, 80.9% (N = 228) tested positive to real time RT-PCR, and among these, 174 tested positive also to LumiraDx™. Compared with real time RT-PCR, which is considered as the gold standard for the assessment of the presence/absence of SARS-CoV-2 infection, LumiraDx™showed an overall sensitivity of 76.3% and specificity of 94.4%. Sensitivity increased to 91% when testing was performed <10 days from symptoms' onset, and to 95% when considering Ct < 25. Multivariable binomial logistic regression showed that false negative LumiraDx™results were significantly associated with high Ct values, and with further testing from symptoms' onset.Conclusions:
The results of our study suggested that the LumiraDx™SARS-CoV-2 antigen assay may be appropriate for the detection of SARS-CoV-2 infection, especially in its early phase when the test largely meets the performance requirements of the European Centre for Disease Prevention and Control (ECDC).
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Collection:
Databases of international organizations
Database:
MDPI
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Language:
English
Journal:
International Journal of Environmental Research and Public Health
Year:
2022
Document Type:
Article
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