期刊
JOURNAL OF CLINICAL MEDICINE
卷 10, 期 7, 页码 -出版社
MDPI
DOI: 10.3390/jcm10071471
关键词
SARS-CoV-2; antigen detection; RT-PCR; saliva samples; diagnosis
资金
- National Institute for Infectious Diseases 'Lazzaro Spallanzani' IRCCS from Ministero della Salute [COVID-2020-12371817]
- European Commission-Horizon 2020 (EU) [101003544, 101003551, 101005111, 101005075]
- European Virus Archive-GLOBAL [653316, 871029]
The study evaluated the performance of a chemiluminescence-based SARS-CoV-2 antigen detection method in saliva samples, showing high reliability and accuracy, especially in individuals with high viral loads. However, in a low prevalence setting, confirmatory testing is still necessary to improve the positive predictive value.
Diagnostic methods based on SARS-CoV-2 antigens detection are a promising alternative to SARS-CoV-2 RNA amplification. We evaluated the automated chemiluminescence-based Lumipulse(R) G SARS-CoV-2 Ag assay on saliva samples, using Simplexa (TM) COVID-19 Direct assay as a reference test. Analytical performance was established on a pool of healthy donors' saliva samples spiked with the 2019-nCoV/Italy-INMI1 isolate, whereas clinical performance was assessed on fresh saliva specimens collected from hospitalized patients with suspect or confirmed COVID-19 diagnosis. The limit of detection (LOD) was 0.65 Log TCID50/mL, corresponding to 18,197 copies/mL of SARS-CoV-2 RNA. Antigen concentrations and SARS-CoV-2 RNA were highly correlated (r = 0.99; p < 0.0001). Substantial agreement (80.3%) and significant correlation (r = -0.675; p = 0.0006) were observed between Lumipulse(R) G assay results and Ct values on clinical samples, with 52.4% sensitivity and specificity 94.1%. Sensitivity exceeded 90.0% when calculated on samples with Ct < 25, and specificity was 100% when excluding samples from recovered patients with previous COVID-19 diagnosis. Overall, chemiluminescence-based antigen assay may be reliably applied to saliva samples to identify individuals with high viral loads, more likely to transmit the virus. However, the low positive predictive value in a context of low SARS-CoV-2 prevalence underscores the need for confirmatory testing in SARS-CoV-2 antigen-positive cases.
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