Evaluation of the rapid antigen detection test STANDARD F COVID-19 Ag FIA for diagnosing SARS-CoV-2: experience from an Emergency Department

García‐Fernández, Sergio; Pablo-Marcos, Daniel; Fuente, Silvia Velasco de la; Rodríguez, María José Reina; Gozalo, Mónica; Rodrı́guez-Lozano, Jesús; Méndez-Legaza, José Manuel; Calvo-Montes, Jorge

doi:10.1016/j.diagmicrobio.2022.115683

Cited by 9 publications

(5 citation statements)

References 18 publications

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“…This contrasts with our study, where NPV is markedly low (74.2 and 68.79% for PanBio and Standard Q, respectively). A study conducted among emergency department attendees in Korea showed that the PPV and NPV of standard COVID antigen test (Biosensor) were 98.1 and 96.4%, respectively [23] . The positive and negative predictive values of BioSensor were found to be 100 and 87.4% in a study conducted in Italy [24] .…”

Section: Discussionmentioning

confidence: 99%

Diagnostic evaluation of PanBio, and standard Q COVID-19 rapid antigen tests for the detection of SARS-CoV-2: a cross-sectional study from Nepal

Yadav,

Karki,

Raut

et al. 2024

International Journal of Surgery: Global Health

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Introduction: The diagnosis of COVID-19 infection was time-consuming and costly, contributing to rampant transmission, particularly in developing countries like Nepal. This study aimed to compare the diagnostic performance of two rapid antigen diagnostic tests (RDTs, PanBio and Standard Q) against real-time reverse transcriptase PCR (rRT-PCR). Methods: This retrospective cross-sectional study was conducted among 1171 suspected COVID-19 patients at a provincial hospital in Nepal. Each participant provided two nasopharyngeal swabs, one for RDT and the other for rRT-PCR, spanning a total duration of four months. Sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of each RDT, as well as the combined antigen-RDT, were determined in reference to the rRT-PCR status. Results: The sensitivity and specificity of PanBio were 60.87% (95% CI: 55.84–65.74) and 98.43% (95% CI: 96.80–99.37), respectively, while that of Standard Q was 59.83% (95% CI: 53.16–66.23) and 96.15% (95% CI: 90.44–98.94), respectively. Positive and negative predictive values of PanBio were 97.14 and 74.20%, respectively, and that of Standard Q were 97.16 and 52.08%. The positive likelihood ratio was higher for PanBio (38.87, 95% CI: 18.56–81.41) than for Standard Q (15.55, 95% CI: 5.92–40.90). Meanwhile, the negative likelihood ratio was more than 0.40 for both RDTs. The accuracy for PanBio, Standard Q, and combined RDTs were 80.91% (95% CI: 78.08–83.52), 71.17% (95% CI: 65.98–75.98), and 78.14% (95% CI: 75.66–80.48), respectively. Conclusion: RDTs exhibited unsatisfactory sensitivity and positive predictive value, rendering them ineffective as a screening tool. Nonetheless, they demonstrated excellent specificity and negative predictive value. Hence, a negative test result almost entirely excludes the possibility of infection.

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Section: Discussionmentioning

confidence: 99%

Diagnostic evaluation of PanBio, and standard Q COVID-19 rapid antigen tests for the detection of SARS-CoV-2: a cross-sectional study from Nepal

Yadav,

Karki,

Raut

et al. 2024

International Journal of Surgery: Global Health

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“…The STANDARD TM F COVID-19 Ag FIA (SD Biosensor, Gyeonggi-do, Korea) is a fluorescent immunoassay for the qualitative detection of SARS-CoV-2 specific N protein from the nasopharyngeal specimens of the suspected individuals. Clinical performance of the STANDARD TM F COVID-19 Ag FIA in 663 specimens from non-repetitive patients demonstrated a clinical sensitivity and specificity of 84.0% and 99.6%, respectively, with the kappa index agreement between RT-PCR and the RAT being 0.89 [ 44 ]. In another study, however, the STANDARD TM F COVID-19 Ag FIA demonstrated a low sensitivity, although the specificity, positive predictive value, and negative predictive value were considered high (38%, 99%, 96.2%, and 72%, respectively).…”

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

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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“…This can be a major drawback, despite their robustness and ease of use. However, analytical sensitivity does not necessarily correspond to clinical relevance [ 10 , 11 ]. Weakly positive RT-PCR results with high Ct values in samples from asymptomatic individuals can lead to unnecessary delays in therapy and excessive repeat testing.…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Testing of Emergency Department Patients Using cobas® Liat® and eazyplex® Rapid Molecular Assays

et al. 2023

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Rapid testing for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) of patients presenting to emergency departments (EDs) facilitates the decision for isolation on admission to hospital wards. Differences in the sensitivity of molecular assays have implications for diagnostic workflows. This study evaluated the performance of the cobas® Liat® RT-PCR, which is routinely used as the initial test for ED patients in our hospitals, compared with the eazyplex® RT-LAMP. A total of 378 oropharyngeal and nasal swabs with positive Liat® results were analysed. Residual sample aliquots were tested using NeuMoDx™, cobas® RT-PCR, and the eazyplex® assay. Patients were divided into asymptomatic (n = 157) and symptomatic (n = 221) groups according to the WHO case definition. Overall, 14% of positive Liat® results were not confirmed by RT-PCR. These samples were mainly attributed to 26.8% of asymptomatic patients, compared to 3.8% of the symptomatic group. Therefore, positive Liat® results were used to provisionally isolate patients in the ED until RT-PCR results were available. The eazyplex® assay identified 62% and 90.6% of RT-PCR-confirmed cases in asymptomatic and symptomatic patients, respectively. False-negative eazyplex® results were associated with RT-PCR Ct values >30, and were more frequent in the asymptomatic group than in the symptomatic group (38.1% vs. 5.1%, respectively). Both the Liat® and eazyplex® assays are suitable for testing symptomatic patients. Their use in screening asymptomatic patients depends on the need to exclude any infection or identify those at high risk of transmission.

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Evaluation of the rapid antigen detection test STANDARD F COVID-19 Ag FIA for diagnosing SARS-CoV-2: experience from an Emergency Department

Cited by 9 publications

References 18 publications

Diagnostic evaluation of PanBio, and standard Q COVID-19 rapid antigen tests for the detection of SARS-CoV-2: a cross-sectional study from Nepal

Diagnostic evaluation of PanBio, and standard Q COVID-19 rapid antigen tests for the detection of SARS-CoV-2: a cross-sectional study from Nepal

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

SARS-CoV-2 Testing of Emergency Department Patients Using cobas® Liat® and eazyplex® Rapid Molecular Assays

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