Evaluation of the Diagnostic Accuracy of Nasal Cavity and Nasopharyngeal Swab Specimens for SARS-CoV-2 Detection via Rapid Antigen Test According to Specimen Collection Timing and Viral Load

Lee, Seungjun; Widyasari, Kristin; Yang, Hye-Ryun; Jang, Jieun; Kang, Taejoon; Kim, Sun‐Joo

doi:10.3390/diagnostics12030710

Cited by 17 publications

(15 citation statements)

References 34 publications

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“…These results may also explain some of the differences in performance observed for SARS-CoV-2 tests across different sample types. [21][22][23] The study did confirm higher antigen concentrations in symptomatic cases compared to asymptomatic and oligosymptomatic cases across all three specimen types, as anticipated given the association between viral carriage and symptom onset. While recent studies suggest that early onset of SARS-CoV-2 can be first observed in the saliva by RT-PCR, 4,5,20 Tables Table 1. Observed sensitivity of the antigen detection tests performed on ANS compared to their predicted performance based on analytical limit-of-detection.…”

Section: Validation Of Predictive Performance Modeling From Analytica...mentioning

confidence: 76%

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Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types

Golden¹,

Oliveira-Silva²,

Slater³

et al. 2022

Preprint

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The relationship between N-antigen concentration and viral load within a specimen and across different specimens is essential for interpretation of rapid diagnostic tests (RDT) clinical performance in different use cases. A prospective study was conducted in Porto Velho, Brazil, to investigate RDT performance in different specimen types as a function of the correlation between antigen concentration and viral load. The study included 214 close contacts with recent exposures to confirmed cases, aged 12 years and older and with various levels of vaccination. Antigen concentration was measured in nasopharyngeal swab (NPS), anterior nares swab (ANS), and saliva specimens. Reverse transcriptase (RT)-PCR was conducted on the NPS and saliva specimens, and two RDTs were conducted on ANS and one on saliva. Antigen concentration correlated with viral load when measured in the same specimen type but not across specimen types. Antigen levels were higher in symptomatic cases compared to asymptomatic/oligosymptomatic cases and lower in saliva compared to NPS and ANS samples. Discordant results between the RDTs conducted on ANS and the RT-PCR on NPS were resolved by antigen concentration values. The analytical limit-of-detection of RDTs can be used to predict the performance of the tests in populations for which the antigen concentration is known. The antigen dynamics across different sample types observed in SARS-CoV-2 disease progression support use of RDTs in nasal samples. Given lower antigen concentrations in saliva, tests using saliva is expected to require improved analytical sensitivity to achieve clinical sensitivity similar to testing of nasal samples.

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Section: Validation Of Predictive Performance Modeling From Analytica...mentioning

confidence: 76%

“…These results may also explain some of the differences in performance observed for SARS-CoV-2 tests across different sample types. 21–23…”

Section: Discussionmentioning

confidence: 99%

Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types

Golden¹,

Oliveira-Silva²,

Slater³

et al. 2022

Preprint

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“…Ct in RT-qPCR refers to the moment when amplification occurs and is deemed as a surrogate marker for viral load. This value is inversely proportional to the viral RNA copy number, and a lower Ct means a high accumulation of viral load ( 10 ). While RT-qPCR is regarded as the reference method for detecting SARS-CoV-2, SARS-CoV-2 RNA detected by this technique does not indicate the presence or shedding of live replication-competent virus, and whether the person was contagious at the time of the test ( 11 ).…”

Section: Discussionmentioning

confidence: 99%

Evaluating the role of SARS-CoV-2 target genes based on two nucleic acid assay kits

Zhu

Zhang

Zhou

et al. 2022

Front. Public Health

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BackgroundEffective isolation and early treatment of coronavirus disease 2019 (COVID-19) relies on rapid, accurate, and straightforward diagnostic tools. In response to the rapidly increasing number of cases, reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assays for multiple target genes have become widely available in the market.MethodsIn total, 236 COVID-19 patients with positive results in both RT-qPCR and rapid antigen diagnosis (Ag-RDT) were enrolled in the study. The cycle threshold (Ct) was compared with different onset times and target genes. Comparison between groups was evaluated with the Kruskal-Wallis test and Dunn test. The correlation between target genes was analyzed by Spearman.ResultsIn samples of Ct ≤ 21, Ct was different for the nucleocapsid (N), open reading frame 1ab (ORF1ab), and envelope (E) genes (P < 0.05). Mild COVID-19 patients within 7 days of onset accounted for 67.80% of all enrolled patients. At the above stage, all target genes reached the trough of Ct, and N genes showed lower values than the other target genes. The Ct of the ORF1ab and N gene in asymptomatic patients differed from those of mild patients within 7 days and more than 14 days of onset. The kits used in the study showed strong consistency among target genes, with all correlation coefficients >0.870.ConclusionRT-qPCR confirmed that the N gene performed well in Ct ≤ 21 and samples within 7 days of onset. Ag-RDT was discriminatory for patients within 7 days of onset. This study facilitated early identification and control of COVID-19 prevalence among patients.

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“…RATs are considered a complement to PCR tests, hence being widely employed in the first phase of screening. Additionally, RATs are cheap and easy to use, enabling point-of-care testing with a short execution time (15–30 min) [ 5 ], making RATs a favorable SARS-CoV-2 detection tool. To date, numerous RATs are commercially available and have been used worldwide.…”

Section: Antigen Tests Amid the Battle Against Sars-cov-2 In Koreamentioning

confidence: 99%

“…Although the PCR test has a high degree of accuracy, the procedure is complex, the data analysis can be time-consuming, and an expert is required to conduct the sophisticated test. Meanwhile, RATs are considered relatively easy to handle and simple to use, do not require expertise, are suitable for point-of-care testing, are low-cost, and have a shorter turnaround time than other diagnostic platforms [ 5 ]. Due to these reasons, RATs are recommended to be used for an individual with symptoms but who cannot get access to timely PCR testing, for individuals who are in close contact with infected individuals, for the first screening of infected individuals before confirmation using a molecular-based test in a high-risk community, or as confirmatory testing after recovery from the infection [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Rapid Antigen Tests during the COVID-19 Era in Korea and Their Implementation as a Detection Tool for Other Infectious Diseases

Widyasari

Kim

2023

Bioengineering

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Rapid antigen tests (RATs) are diagnostic tools developed to specifically detect a certain protein of infectious agents (viruses, bacteria, or parasites). RATs are easily accessible due to their rapidity and simplicity. During the COVID-19 pandemic, RATs have been widely used in detecting the presence of the specific SARS-CoV-2 antigen in respiratory samples from suspected individuals. Here, the authors review the application of RATs as detection tools for COVID-19, particularly in Korea, as well as for several other infectious diseases. To address these issues, we present general knowledge on the design of RATs that adopt the lateral flow immunoassay for the detection of the analyte (antigen). The authors then discuss the clinical utilization of the authorized RATs amidst the battle against the COVID-19 pandemic in Korea and their role in comparison with other detection methods. We also discuss the implementation of RATs for other, non-COVID-19 infectious diseases, the challenges that may arise during the application, the limitations of RATs as clinical detection tools, as well as the possible problem solving for those challenges to maximize the performance of RATs and avoiding any misinterpretation of the test result.

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Evaluation of the Diagnostic Accuracy of Nasal Cavity and Nasopharyngeal Swab Specimens for SARS-CoV-2 Detection via Rapid Antigen Test According to Specimen Collection Timing and Viral Load

Cited by 17 publications

References 34 publications

Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types

Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types

Evaluating the role of SARS-CoV-2 target genes based on two nucleic acid assay kits

Rapid Antigen Tests during the COVID-19 Era in Korea and Their Implementation as a Detection Tool for Other Infectious Diseases

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