Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study

Autor: Anna Maria Cattelan, Carlo Federico Zambon, Mario Plebani, Filippo Navaglia, Chiara Cosma, Daniela Basso, Nicole Contran, Stefania Moz, Ada Aita, Andrea Padoan
Rok vydání: 2021
Předmět:
0301 basic medicine
Saliva
Chemiluminescence
(CLEIA)
chemiluminescent assay
Clinical Biochemistry
Naso-pharyngeal swab
(ROC)
receiver operating characteristic
Biochemistry
Gastroenterology
0302 clinical medicine
(POC)
point-of-care
COVID-19
Point-of-care
Antigens
Viral
Humans
Luminescent Measurements
Nasopharynx
Pandemics
Point-of-Care Testing
Prospective Studies
SARS-CoV-2
Sensitivity and Specificity
Medicine
Viral
Antigen testing
Prospective cohort study
General Medicine
(AUC)
area under the receiver operating characteristic curve
030220 oncology & carcinogenesis
Viral load
medicine.medical_specialty
Point-of-care testing
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Rapid detection
Article
03 medical and health sciences
Antigen
Internal medicine
Immunochromatographic Assays
Symptom onset
Antigens
(NPS)
naso-pharyngeal swab
business.industry
Biochemistry (medical)
(SD)
standard deviation
030104 developmental biology
Immunology
business
Zdroj: Clinica Chimica Acta; International Journal of Clinical Chemistry
ISSN: 1873-3492
Popis: BackgroundSARS-CoV-2 quick testing and reporting are now considered relevant for the containment of new pandemic waves. Antigen testing in self-collected saliva might be useful. We compared the diagnostic performance of salivary and naso-pharyngeal swab (NPS) SARS-CoV-2 antigen detection by a rapid chemiluminescent assay (CLEIA) and two different point-of-care (POC) immunochromatographic assays, with that of molecular testing.Methods234 patients were prospectively enrolled. Paired self-collected saliva (Salivette) and NPS were obtained to perform rRT-PCR, chemiluminescent (Lumipulse G) and POC (NPS: Fujirebio and Abbott; saliva: Fujirebio) for SARS-CoV-2 antigen detection.ResultsThe overall agreement between NPS and saliva rRT-PCR was 78.7%, reaching 91.7% at the first week from symptoms onset. SARS-CoV-2 CLEIA antigen was highly accurate in distinguishing between positive and negative NPS (ROC-AUC=0.939, 95%CI:0.903-0.977), with 81.6% sensitivity and 93.8% specificity. This assay on saliva had an overall good accuracy (ROC-AUC=0.805, 95%CI:0.740-0.870), reaching the optimal value within 7 days from symptom onset (Sensitivity: 72%; Specificity: 97%). POC antigen in saliva had a very limited sensitivity (13%), performing better in NPS (Sensitivity: 48% and 66%; Specificity: 100% and 99% for Espline and Abbott respectively), depending on viral loads.ConclusionsSelf-collected saliva is a valid alternative to NPS for SARS-CoV-2 detection not only by molecular, but also by CLEIA antigen testing, for which the highest diagnostic accuracy was achieved in the first week from symptom onset. Saliva is not suitable for POC, although the accuracy of these tests appears satisfactory for NPS with high viral load.
Databáze: OpenAIRE
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