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Evaluation of false positives in the SARS-CoV-2 quantitative antigen test
- Source :
- Journal of Infection and Chemotherapy
- Publication Year :
- 2021
- Publisher :
- Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd., 2021.
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Abstract
- Introduction Highly sensitive reagents for detecting SARS-CoV-2 antigens have been developed for accurate and rapid diagnosis till date. In this study, we aim to clarify the frequency of false-positive reactions and reveal their details in SARS-CoV-2 quantitative antigen test using an automated laboratory device. Methods Nasopharyngeal swab samples (n = 4992) and saliva samples (n = 5430) were collected. We measured their SARS-CoV-2 antigen using Lumipulse® Presto SARS-CoV-2 Ag and performed a nucleic acid amplification test (NAAT) using the Ampdirectâ„¢ 2019 Novel Coronavirus Detection Kit as needed. The results obtained from each detection test were compared accordingly. Results There were 304 nasopharyngeal samples and 114 saliva samples were positive in the Lumipulse® Presto SARS-CoV-2 Ag test. All positive nasopharyngeal samples in the antigen test were also positive for NAAT. In contrast, only three (2.6%) of all the positive saliva samples in the antigen test were negative for NAAT. One showed no linearity with a dilute solution in the dilution test. Additionally, the quantitative antigen levels of all the three samples did not decrease after reaction with the anti-SARS-CoV-2 antibody. Conclusions The judgment difference between the quantitative antigen test and NAAT seemed to be caused by non-specific reactions in the antigen test. Although the high positive and negative predictive value of this quantitative antigen test could be confirmed, we should consider the possibility of false-positives caused by non-specific reactions and understand the characteristics of antigen testing. We recommend that repeating centrifugation before measurement, especially in saliva samples, should be performed appropriately.
- Subjects :
- Microbiology (medical)
non-specific reaction
Saliva
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
detection
Sensitivity and Specificity
Laboratory device
antigen
Antigen
Nasopharynx
False positive paradox
Humans
Medicine
False Positive Reactions
Pharmacology (medical)
biology
business.industry
SARS-CoV-2
COVID-19
Antigen test
Highly sensitive
Infectious Diseases
Immunology
biology.protein
Original Article
Antibody
business
Subjects
Details
- Language :
- English
- ISSN :
- 14377780 and 1341321X
- Database :
- OpenAIRE
- Journal :
- Journal of Infection and Chemotherapy
- Accession number :
- edsair.doi.dedup.....539c67bf17666d7ef4b6cbac6b14d0ea