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Detection of SARS-CoV-2 by Rapid Antigen Tests on Saliva Expected to Lower the Impact of Post COVID-19

Zhang Lei*, Yang Feng, Wu Yanli

Background: Most people can fully recover from coronavirus disease 2019 (COVID-19), but some may remain with long-term side effects on several systems of the body including pulmonary, cardiovascular, nervous systems, as well as psychological effects. These effects appear to be independent of aged adults and those with more initial symptoms. Some individuals infected with SARS-CoV-2 will develop long-term symptoms. Definitions of this emerging disease vary, leading to complexity in advancing research and clinical policy development. During the pandemic, various terms have been used including long COVID, long-haul COVID, or post-COVID-19 status as used by the World Health Organization (WHO). Despite this, a global standardized clinical case definition is still lacking. Moreover, the lack of a single terminology and clinical case definition has been repeatedly cited as a barrier to advancing research and management of these patients. Antigen Rapid Test is one of the most effective detection methods for SARS-CoV-2 infections. This method improves test efficiency and can be used at home by reading simple operating instructions. If an infection is detected and isolated immediately, it can aid in effective protection.

Aim: To explore the efficiency of rapid antigen test on saliva within impact of post COVID-19, this study aims to evaluate performance of Citest SARS-CoV-2 (COVID-19) Antigen Rapid Test (Oral Fluid) by comparing the results with RT-PCR (Nasopharyngeal swab) method.

Methods: The SARS-CoV-2 (COVID-19) Rapid Test (Oral Fluid) is a qualitative membrane based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein Antigens in human oral fluid specimen. A clinical evaluation was conducted comparing the results obtained using the SARS-CoV-2 (COVID-19) Rapid Test (Oral Fluid) with RT-PCR (Nasopharyngeal swab) test results.

Results: Sensitivity (94.3%): In total 297 PCR confirmed positive samples: 280 PCR confirmed positive samples were correctly detected by SARS-CoV-2 (COVID-19) Rapid Test (Oral Fluid). 17 false negative cases were reported. Specificity (99.4%): In total 352 PCR confirmed negative samples: 350 PCR confirmed negative samples were correctly detected by SARS-CoV-2 (COVID-19) Rapid Test (Oral Fluid). 2 false positive cases were reported. Accuracy (97.1%): In total 649 PCR confirmed samples: 630 PCR confirmed samples were correctly detected by SARS-CoV-2 (COVID-19) Rapid Test (Oral Fluid). The observed accuracy may vary depending on the prevalence of the virus in the population.

Conclusion: Citest SARS-CoV-2 (COVID-19) Antigen Rapid Test (Oral Fluid) has potential benefit to detection, as the test kit has short turnaround times, easy to read operating procedure and can be used in decentralized testing. This finding suggests that rapid antigen testing could be an effective tool for rapid control of COVID-19. In addition, these tests can also be performed by a layperson or at home to initially identify COVID-19, which will limit the spread of the disease.

Keywords: SARS-CoV-2; Post COVID-19; Antigen Rapid Test; Saliva

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