scholarly journals Factors that Influence the Reported Sensitivity of Rapid Antigen Testing for SARS-CoV-2

2021 ◽  
Vol 12 ◽  
Author(s):  
Valentin Parvu ◽  
Devin S. Gary ◽  
Joseph Mann ◽  
Yu-Chih Lin ◽  
Dorsey Mills ◽  
...  
Keyword(s):  
High Sensitivity ◽  
Upper Respiratory Tract ◽  
Antigen Test ◽  
Test Sensitivity ◽  
Viral Culture ◽  
Polymerase Chain ◽  
Asymptomatic Individuals ◽  
Design Factors ◽  
Antigen Testing

Tests that detect the presence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigen in clinical specimens from the upper respiratory tract can provide a rapid means of coronavirus disease 2019 (COVID-19) diagnosis and help identify individuals who may be infectious and should isolate to prevent SARS-CoV-2 transmission. This systematic review assesses the diagnostic accuracy of SARS-CoV-2 antigen detection in COVID-19 symptomatic and asymptomatic individuals compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) and summarizes antigen test sensitivity using meta-regression. In total, 83 studies were included that compared SARS-CoV-2 rapid antigen-based lateral flow testing (RALFT) to RT-qPCR for SARS-CoV-2. Generally, the quality of the evaluated studies was inconsistent; nevertheless, the overall sensitivity for RALFT was determined to be 75.0% (95% confidence interval: 71.0–78.0). Additionally, RALFT sensitivity was found to be higher for symptomatic vs. asymptomatic individuals and was higher for a symptomatic population within 7 days from symptom onset compared to a population with extended days of symptoms. Viral load was found to be the most important factor for determining SARS-CoV-2 antigen test sensitivity. Other design factors, such as specimen storage and anatomical collection type, also affect the performance of RALFT. RALFT and RT-qPCR testing both achieve high sensitivity when compared to SARS-CoV-2 viral culture.

scholarly journals Clinical and experimental factors that affect the reported performance characteristics of rapid testing for SARS-CoV-2

2021 ◽  
Author(s):  
Valentin Parvu ◽  
Devin Gary ◽  
Joseph Mann ◽  
Yu-Chih Lin ◽  
Dorsey Mills ◽  
...  
Keyword(s):  
High Sensitivity ◽  
Disease Diagnosis ◽  
Upper Respiratory Tract ◽  
Antigen Test ◽  
Test Sensitivity ◽  
Viral Culture ◽  
Upper Respiratory ◽  
Asymptomatic Individuals ◽  
Design Factors

ABSTRACT Tests that detect the presence of SARS-CoV-2 antigen in clinical specimens from the upper respiratory tract can provide a rapid means of COVID-19 disease diagnosis and help identify individuals that may be infectious and should isolate to prevent SARS-CoV-2 transmission. This systematic review assesses the diagnostic accuracy of SARS-CoV-2 antigen detection in COVID-19 symptomatic and asymptomatic individuals compared to RT-qPCR, and summarizes antigen test sensitivity using meta-regression. In total, 83 studies were included that compared SARS-CoV-2 rapid antigen lateral flow testing (RALFT) to RT-qPCR for SARS-CoV-2. Generally, the quality of the evaluated studies was inconsistent, nevertheless, the overall sensitivity for RALFT was determined to be 75.0% (95% confidence interval [CI]: 71.0-78.0). Additionally, RALFT sensitivity was found to be higher for symptomatic versus asymptomatic individuals and was higher for a symptomatic population within 7 days from symptom onset (DSO) compared to a population with extended days of symptoms. Viral load was found to be the most important factor for determining SARS-CoV-2 antigen test sensitivity. Other design factors, such as specimen storage and anatomical collection type, also affect the performance of RAFLT. RALFT and RT-qPCR testing both achieve high sensitivity when compared to SARS-CoV-2 viral culture.

scholarly journals Performance of Repeat BinaxNOW SARS-CoV-2 Antigen Testing in a Community Setting, Wisconsin, November-December 2020

2021 ◽  
Author(s):  
Melisa M. Shah ◽  
Phillip P. Salvatore ◽  
Laura Ford ◽  
Emiko Kamitani ◽  
Melissa J. Whaley ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Reverse Transcription ◽  
Community Setting ◽  
Antigen Test ◽  
Chain Reaction ◽  
Test Sensitivity ◽  
High Concordance ◽  
Polymerase Chain ◽  
Antigen Testing

Repeating the BinaxNOW antigen test for SARS-CoV-2 by two groups of readers within 30 minutes resulted in high concordance (98.9%) in 2,110 encounters. BinaxNOW test sensitivity was 77.2% (258/334) compared to real-time reverse transcription-polymerase chain reaction. Same day antigen testing did not significantly improve test sensitivity while specificity remained high.

scholarly journals Antigen Testing for COVID-19 Asymptomatic Screening: Why it Should be Preferred Over PCR Insights From Navy Region Japan’s Experience With a Comprehensive Antigen Testing Strategy

2021 ◽  
Author(s):  
Ross A Mullinax
Keyword(s):  
Public Health ◽  
Infectious Virus ◽  
Infectious Period ◽  
Test Results ◽  
Testing Strategy ◽  
Viral Loads ◽  
Viral Culture ◽  
Polymerase Chain ◽  
Antigen Testing

ABSTRACT Polymerase chain reaction (PCR) is commonly used in asymptomatic screening testing, but is suboptimal for this purpose as it will identify many old persistent positives that are no longer infectious. This can result in placement of individuals that are not infectious to others into isolation. This results in substantial adverse impact to military manning and operations, without any benefit to public health. Antigen testing does not have this same drawback. Antigen testing, while less sensitive than PCR, will identify the vast majority of infectious positives, especially those with higher viral loads that are more likely to transmit to others. Importantly, use of antigen testing will also greatly increase the certainty of benefit from isolation, reducing the risk of isolating those individuals who are beyond their infectious period and pose no threat to public health. The literature on this topic is reviewed, with particular focus on studies that perform viral culture in addition to PCR and antigen testing. This allows for determination of sensitivity for infectious virus. Also, Navy Region Japan’s experience with a comprehensive antigen testing strategy is described. The challenges presented by persistent positive PCR test results are examined, as well as the real-world benefits from implementing widespread use of antigen testing.

scholarly journals High Sensitivity and NPV for BinaxNOW Rapid Antigen Test in Children at a Mass Testing Site During Prevalent Delta Variant

2022 ◽  
Author(s):  
Kristie J Sun ◽  
Mary Jane E Vaeth ◽  
Matthew L Robinson ◽  
Maryam Elhabashy ◽  
Ishaan Gupta ◽  
...  
Keyword(s):  
Predictive Value ◽  
High Sensitivity ◽  
High Volume ◽  
Educational Opportunities ◽  
Antigen Test ◽  
Sample Collection ◽  
Rt Pcr ◽  
Polymerase Chain ◽  
Testing Site ◽  
Antigen Tests

SARS-CoV-2 continues to develop new, increasingly infectious variants, such as delta and omicron. Here, we evaluate the efficacy of the Abbott BinaxNOW Rapid Antigen Test against the gold standard of Reverse Transcription Polymerase Chain Reaction (RT-PCR) in 1054 pediatric participants presenting to a state-owned high-volume Coronavirus Disease 2019 (COVID-19) testing site. During the testing period, the delta variant was predominant. Prior to sample collection, symptomatic and exposure status was collected for all participants based on Centers for Disease Control (CDC) criteria. RT-PCR results demonstrated an overall prevalence rate of 5.2%. For all participants, the sensitivity of the rapid antigen tests was 92.7% (95% CI 82.4% - 98.0%) and specificity was 98.0% (95% CI 97.0%-98.8%). For symptomatic participants, the sensitivity was 92.3% (95% CI 74.9% - 99.1%), specificity was 96.6% (95% CI 93.6%- 98.4%), positive predictive value (PPV) was 72.7% (95% CI 54.5% - 86.7%) and negative predictive value (NPV) was 99.2% (95% CI 98.2% - 100%). Among asymptomatic participants, the sensitivity was 92.6% (95% CI 75.7% - 99.1%), specificity was 98.6% (95% CI 97.5% - 99.3%) the PPV was 71.4% (95% CI 53.7% - 85.4%) and the NPV was 99.7% (95% CI 99.0% - 100%). Our reported sensitivity and NPV are higher than other pediatric studies, but specificity and PPV are lower. Importance Children are especially impacted by the disease and its ability to disrupt educational opportunities. Although vaccinations have been approved for children 5 years and older, many children remain unvaccinated. Widespread testing may improve the ability for children to remain in in-person activities, minimizing absences from school and extracurriculars. Highly accurate rapid antigen tests may be vital to containing future COVID-19 waves while mitigating detrimental effects.

scholarly journals Diagnostic Performance of a Rapid Antigen Test Compared with the Reverse Transcription Polymerase Chain Reaction for SARS-CoV-2 Detection in Asymptomatic Individuals Referring to a Drive-in Testing Facility

COVID ◽  
2021 ◽  
Vol 1 (4) ◽  
pp. 784-789
Author(s):  
Fabio Lombardo ◽  
Gianluca Triolo ◽  
Biao Yang ◽  
Zhonghua Liu ◽  
Paolo Maiuri ◽  
...  
Keyword(s):  
Prospective Observational Study ◽  
High Specificity ◽  
Nucleic Acid Detection ◽  
Antigen Test ◽  
Chain Reaction ◽  
Viral Loads ◽  
Assay Performance ◽  
Testing Facility ◽  
Polymerase Chain ◽  
Asymptomatic Individuals

Quick and reliable identification of severe acute respiratory syndrome coronavirus SARS-CoV-2 in the population is required to manage the COVID-19 pandemic. This is a prospective observational study of diagnostic accuracy. Paired swab samples from 317 asymptomatic individuals referring to a drive-in testing facility were tested in parallel by means of the rapid antigen test developed by Jiangsu Bioperfectus Technologies and routine nucleic acid detection. Overall specificity was 100% and sensitivity was 49% but reached 87% at higher viral loads (Ct < 25). In this study, the antigen detection test showed high specificity and good sensitivity in asymptomatic individuals carrying higher viral loads. The assay performance worsened with lower viral loads, making it useful when a rapidly deployable test is essential and to assess a potential risk of immediate transmission in the community, but not recommended for testing asymptomatic individuals.

scholarly journals Evaluation and clinical implications of the time to a positive results of antigen testing for SARS-CoV-2

2021 ◽  
Author(s):  
Yusaku Akashi ◽  
Yoshihiko Kiyasu ◽  
Yuto Takeuchi ◽  
Daisuke Kato ◽  
Miwa Kuwahara ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Clinical Implications ◽  
Antigen Test ◽  
Test Sensitivity ◽  
Reverse Transcription Pcr ◽  
Time Period ◽  
Antigen Tests ◽  
Respiratory Coronavirus ◽  
Antigen Testing ◽  
Positive Results

Antigen tests for severe acute respiratory coronavirus 2 sometimes show positive lines earlier than their specified read time, although the implication of getting the results at earlier time is not well understood. This study aimed to evaluate the clinical utility of an antigen test by evaluating the time period to get positive results and by comparing the test sensitivity with that of a digital immunoassay (DIA) test. We prospectively collected additional nasopharyngeal samples from patients who had already tested positive for SARS-CoV-2 by reverse transcription PCR. The additional swab was used for an antigen test, QuickNavi™-COVID19 Ag, and the time periods to get positive results were measured. The sensitivity of QuickNavi™-COVID19 Ag was also compared with that of a DIA. In 84 of 96 (87.5%) analyzed cases, the results of QuickNavi™-COVID19 Ag were positive. The time to obtain positive results was 15.0 seconds in median (inter quartile range: 12.0-33.3, range 11-736), and was extended in samples with higher cycle thresholds (Ct) (p<0.001). Positive lines appeared within a minute in 85.7% of cases and within 5 minutes in 96.4%. The sensitivities of QuickNavi™-COVID19 Ag and the DIA were 87.5% (95% confident interval [CI]: 79.2%-93.4%) and 88.6% (95%CI: 75.4%-96.2%), respectively. Their results were concordant in 90.9% of cases, with discrepancies present only in cases with Ct values >32. QuickNavi™-COVID19 Ag immediately showed positive results in most cases, and the time to a positive reaction may have indicated the viral load. In addition, the sensitivity of the test was comparable to the DIA.

scholarly journals Detection of SARS-CoV-2 nucleocapsid antigen from serum can aid in timing of COVID-19 infection

2021 ◽  
Author(s):  
MJ Ahava ◽  
S Kurkela ◽  
S Kuivanen ◽  
M Lappalainen ◽  
H Jarva ◽  
...  
Keyword(s):  
Enzyme Linked Immunosorbent Assay ◽  
Upper Respiratory Tract ◽  
Antigen Test ◽  
Sample Collection ◽  
Antibody Testing ◽  
Serum Samples ◽  
Diagnostic Pcr ◽  
Test Sensitivity ◽  
Specificity And Sensitivity ◽  
Kinetics Of

AbstractSARS-CoV-2 RNA can be detected in respiratory samples for weeks or even months after onset of COVID-19 disease. Therefore, one of the diagnostic challenges of PCR positive cases is differentiating between acute COVID-19 disease and convalescent phase. Recently, the presence of SARS-CoV-2 nucleocapsid antigen in serum samples of COVID-19 patients was published [Le Hingrat et al. Detection of SARS-CoV-2 N-antigen in blood during acute COVID-19 provides a sensitive new marker and new testing alternatives, Clinical Microbiology and Infection, 2020].Our study aimed to characterize the analytical specificity and sensitivity of an enzyme-linked immunosorbent assay (Salocor SARS-CoV-2 Antigen Quantitative Assay Kit© (Salofa Ltd, Salo, Finland)) for the detection of SARS-CoV-2 antigen in serum, and to characterize the kinetics of antigenemia. The evaluation material included a negative serum panel of 155 samples, and 126 serum samples from patients with PCR-confirmed COVID-19.The specificity of the Salocor SARS-CoV-2 serum N antigen test was 98.0%. In comparison with simultaneous positive PCR from upper respiratory tract (URT) specimens, the test sensitivity was 91.7%. In a serum panel in which the earliest serum sample was collected two days before the collection of positive URT specimen, and the latest 48 days after (median 1 day post URT sample collection), the serum N antigen test sensitivity was 94% within 14 days post onset of symptoms. The antigenemia resolved approximately two weeks after the onset of disease and diagnostic PCR.The combination of simultaneous SARS-CoV-2 antigen and antibody testing appeared to provide useful information for the timing of COVID-19. Our results suggest that SARS-CoV-2 N-antigenemia may be used as a diagnostic marker in acute COVID-19.

scholarly journals SARS-CoV-2 Rapid Antigen Testing of Symptomatic and Asymptomatic Individuals on the University of Arizona Campus

Biomedicines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 539
Author(s):  
David T. Harris ◽  
Michael Badowski ◽  
Brandon Jernigan ◽  
Ryan Sprissler ◽  
Taylor Edwards ◽  
...  
Keyword(s):  
Disease Transmission ◽  
Antigen Test ◽  
University Campuses ◽  
University Of Arizona ◽  
The Us ◽  
Asymptomatic Individuals ◽  
Asymptomatic Subjects ◽  
The University ◽  
Antigen Testing ◽  
Public Demand

SARS-CoV-2, the cause of COVID19, has caused a pandemic that has infected a pandemic that has infected more than 80 M and killed more than 1.6 M persons worldwide. In the US as of December 2020, it has infected more than 32 M people while causing more than 570,000 deaths. As the pandemic persists, there has been a public demand to reopen schools and university campuses. To consider these demands, it is necessary to rapidly identify those individuals infected with the virus and isolate them so that disease transmission can be stopped. In the present study, we examined the sensitivity of the Quidel Rapid Antigen test for use in screening both symptomatic and asymptomatic individuals at the University of Arizona from June to August 2020. A total of 885 symptomatic and 1551 asymptomatic subjects were assessed by antigen testing and real-time PCR testing. The sensitivity of the test for both symptomatic and asymptomatic persons was between 82 and 90%, with some caveats.

scholarly journals SARS-CoV-2 transmission in intercollegiate athletics not fully mitigated with daily antigen testing

2021 ◽  
Author(s):  
Gage K. Moreno ◽  
Katarina M. Braun ◽  
Ian W. Pray ◽  
Hannah E. Segaloff ◽  
Ailam Lim ◽  
...  
Keyword(s):  
Intercollegiate Athletics ◽  
High Frequency ◽  
Index Patient ◽  
Mitigation Strategies ◽  
Athletic Programs ◽  
Test Results ◽  
Antigen Test ◽  
Rt Pcr ◽  
Polymerase Chain ◽  
Antigen Testing

AbstractBackgroundHigh frequency, rapid turnaround SARS-CoV-2 testing continues to be proposed as a way of efficiently identifying and mitigating transmission in congregate settings. However, two SARS-CoV-2 outbreaks occurred among intercollegiate university athletic programs during the fall 2020 semester despite mandatory directly observed daily antigen testing.MethodsDuring the fall 2020 semester, athletes and staff in both programs were tested daily using Quidel’s Sofia SARS Antigen Fluorescent Immunoassay (FIA), with positive antigen results requiring confirmatory testing with real-time reverse transcription polymerase chain reaction (RT-PCR). We used genomic sequencing to investigate transmission dynamics in these two outbreaks.ResultsIn Outbreak 1, 32 confirmed cases occurred within a university athletics program after the index patient attended a meeting while infectious despite a negative antigen test on the day of the meeting. Among isolates sequenced from Outbreak 1, 24 (92%) of 26 were closely related, suggesting sustained transmission following an initial introduction event. In Outbreak 2, 12 confirmed cases occurred among athletes from two university programs that faced each other in an athletic competition despite receiving negative antigen test results on the day of the competition. Sequences from both teams were closely related and unique from strains circulating in the community, suggesting transmission during intercollegiate competition.ConclusionsThese findings suggest that antigen testing alone, even when mandated and directly observed, may not be sufficient as an intervention to prevent SARS-CoV-2 outbreaks in congregate settings, and highlights the importance of supplementing serial antigen testing with appropriate mitigation strategies to prevent SARS-CoV-2 outbreak in congregate settings.SummaryHigh frequency, rapid turnaround SARS-CoV-2 testing continues to be proposed as a way of efficiently identifying and mitigating transmission in congregate settings. However, here we describe two SARS-CoV-2 outbreaks occurred among intercollegiate university athletic programs during the fall 2020 semester.

scholarly journals The usefulness of antigen testing in predicting contagiousness in COVID-19

2021 ◽  
Author(s):  
Tulio J. Lopera ◽  
Francisco J. Diaz ◽  
Juan C. Alzate-Angel ◽  
Maria Teresa Rugeles ◽  
Wbeimar Aguilar-Jimenez
Keyword(s):  
World Economy ◽  
Diagnostic Performance ◽  
Daily Activities ◽  
Antigen Test ◽  
Rt Pcr ◽  
Viral Culture ◽  
The World ◽  
Diagnostic Capacity ◽  
The One ◽  
Antigen Testing

Increasing the diagnostic capacity of COVID-19 (SARS-CoV-2 infection) is required to improve case detection, reduce COVID-19 expansion, and boost the world economy. Rapid antigen detection tests are cheaper and easier to implement, but their diagnostic performance has been questioned compared to RT-PCR. Here, we evaluate the performance of the Standard Q COVID-19 antigen test for diagnosing SARS-CoV-2 infection and predicting contagiousness compared to RT-PCR and viral culture, respectively. The antigen test was 100.0% specific but only 40.9% sensitive for diagnosing infection compared to RT-PCR. Interestingly, SARS-CoV-2 contagiousness is highly unlikely with a negative antigen test since it exhibited a negative predictive value of 99.9% than viral culture. Furthermore, a cycle threshold (Ct) value of 18.1 in RT-PCR was shown to be the one that best predicts contagiousness (AUC 97.6%). Thus, screening people with antigen testing is a good approach to prevent SARS-CoV-2 contagion and allow returning to daily activities.

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