scholarly journals Evaluating the clinical utility and sensitivity of SARS-CoV-2 antigen testing in relation to RT-PCR Ct values

Infection ◽  
2020 ◽  
Author(s):  
Lukas Lanser ◽  
Rosa Bellmann-Weiler ◽  
Karla-Wanda Öttl ◽  
Lukas Huber ◽  
Andrea Griesmacher ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Rt Pcr ◽  
Antigen Testing

scholarly journals Implementing SARS-CoV-2 Rapid Antigen Testing in the Emergency Ward of a Swiss University Hospital: The INCREASE Study

2021 ◽  
Vol 9 (4) ◽  
pp. 798
Author(s):  
Giorgia Caruana ◽  
Antony Croxatto ◽  
Eleftheria Kampouri ◽  
Antonios Kritikos ◽  
Onya Opota ◽  
...  
Keyword(s):  
Immunoglobulin A ◽  
University Hospital ◽  
Lower Sensitivity ◽  
Clinical Settings ◽  
Rt Pcr ◽  
Emergency Ward ◽  
Viral Loads ◽  
Asymptomatic Patients ◽  
Asymptomatic Subjects ◽  
Antigen Testing

Following the Swiss Federal Office of Public Health (FOPH) authorization of the rapid antigen test (RAT), we implemented the use of the RAT in the emergency ward of our university hospital for patients’ cohorting. RAT triaging in association with RT-PCR allowed us to promptly isolate positive patients and save resources. Among 532 patients, overall sensitivities were 48.3% for Exdia and 41.2% for Standard Q®, PanbioTM and BD Veritor™. All RATs exhibited specificity above 99%. Sensitivity increased to 74.6%, 66.2%, 66.2% and 64.8% for Exdia, Standard Q®, PanbioTM and BD Veritor™, respectively, for viral loads above 105 copies/mL, to 100%, 97.8%, 96.6% and 95.6% for viral loads above 106 copies/mL and 100% for viral loads above 107 copies/mL. Sensitivity was significantly higher for patients with symptoms onset within four days (74.3%, 69.2%, 69.2% and 64%, respectively) versus patients with the evolution of symptoms longer than four days (36.8%, 21.1%, 21.1% and 23.7%, respectively). Among COVID-19 asymptomatic patients, sensitivity was 33%. All Immunoglobulin-A-positive patients resulted negative for RAT. The RAT might represent a useful resource in selected clinical settings as a complementary tool in RT-PCR for rapid patient triaging, but the lower sensitivity, especially in late presenters and COVID-19 asymptomatic subjects, must be taken into account.

scholarly journals Screening, Diagnostic and Prognostic Tests for COVID-19: A Comprehensive Review

Life ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 561
Author(s):  
Mariana Ulinici ◽  
Serghei Covantev ◽  
James Wingfield-Digby ◽  
Apostolos Beloukas ◽  
Alexander G. Mathioudakis ◽  
...  
Keyword(s):  
Point Of Care ◽  
Standard Test ◽  
Current Evidence ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Diagnostic Screening ◽  
Comprehensive Review ◽  
Prognostic Tests ◽  
Polymerase Chain ◽  
Antigen Testing

While molecular testing with real-time polymerase chain reaction (RT-PCR) remains the gold-standard test for COVID-19 diagnosis and screening, more rapid or affordable molecular and antigen testing options have been developed. More affordable, point-of-care antigen testing, despite being less sensitive compared to molecular assays, might be preferable for wider screening initiatives. Simple laboratory, imaging and clinical parameters could facilitate prognostication and triage. This comprehensive review summarises current evidence on the diagnostic, screening and prognostic tests for COVID-19.

scholarly journals Assessment of the National Test Strategy on the Development of the COVID-19 Pandemic in Denmark

Epidemiologia ◽  
2021 ◽  
Vol 2 (4) ◽  
pp. 540-552
Author(s):  
Peter Kamp Busk ◽  
Thomas Birk Kristiansen ◽  
Allan Engsig-Karup
Keyword(s):  
Educational Institutions ◽  
Free Access ◽  
Testing Strategy ◽  
Rt Pcr ◽  
Test Strategy ◽  
Testing Frequency ◽  
National Test ◽  
The Relationship ◽  
Antigen Testing

During the COVID-19 pandemic, Denmark has pursued a mass testing strategy culminating in the testing of 12.167 individuals per 100,000 inhabitants per day during the spring of 2021. The strategy included free access to COVID-19 testing, and since 2021, compulsory documentation for negative tests or vaccination has been required for access to workplace, educational institutions, restaurants, and many other places. Testing and subsequent isolation if testing was positive were voluntary. The present study provides an analysis of whether testing frequency in Denmark showed any correlation to hospitalizations throughout the relevant stages of the pandemic. Mass testing was found not to correlate significantly with the number of hospitalizations during the pandemic. Interestingly, during the highest level of testing in spring 2021 the fraction of positive tests increased slightly; thus, the Danish mass testing strategy, at its best, failed to reduce the prevalence of COVID-19. Furthermore, the relationship between positives in antigen testing and in rt-PCR testing indicated that many patients were not tested early in their infection when the risk of transmission was at the highest. In conclusion, the Danish mass testing strategy for COVID-19 does not appear to have a detectable correlation to the number of hospitalizations due to COVID-19.

scholarly journals Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients: results of a prospective comparative trial (RESTART)

2021 ◽  
Author(s):  
Antonios Kritikos ◽  
Giorgia Caruana ◽  
René Brouillet ◽  
John-Paul Miroz ◽  
Abed-Maillard Samia ◽  
...  
Keyword(s):  
Comparative Trial ◽  
Hospitalized Patients ◽  
Rt Pcr ◽  
Duration Of Symptoms ◽  
Non Invasive ◽  
Viral Transport Medium ◽  
One Step ◽  
Antigen Tests ◽  
Low Sensitivity ◽  
Antigen Testing

AbstractObjectivesSaliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study we compared antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples.MethodsWe conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland).ResultsA total of 58 paired NP-saliva specimens were collected. Thirty-two of 58 (55%) patients were hospitalized in the intensive care unit and the median duration of symptoms was 11 days (IQR 5-19). NP and salivary RT-PCR exhibited sensitivity of 98% and 69% respectively whereas the specificity of these RT-PCRs assays were of 100%. NP RAT exhibited much lower diagnostic performances with sensitivities of 35% and 41% for the Standard Q® and Exdia® assays respectively, when a wet-swab approach was used (i.e. when the swab was diluted in the viral transport medium (VTM) before testing). The sensitivity of the dry-swab approach was slightly better (47%). These antigen tests exhibited very low sensitivity (4 and 8%) when applied to salivary swabs.ConclusionsNasopharyngeal RT-PCR is the most accurate test for COVID-19 diagnosis in hospitalized patients. RT-PCR on salivary samples may be used when nasopharyngeal swabs are contraindicated. RAT are not appropriate for hospitalized patients.

scholarly journals Comparison of SARS-CoV-2 antigen electrochemiluminescence immunoassay to RT-PCR assay for laboratory diagnosis of COVID-19 in Peshawar

Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Bilal Iqbal ◽  
Maria Khan ◽  
Noman Shah ◽  
Mirza Muhammad Dawood ◽  
Valeed Jehanzeb ◽  
...  
Keyword(s):  
Laboratory Diagnosis ◽  
Cross Sectional Study ◽  
Antigen Test ◽  
Rt Pcr ◽  
Pcr Assay ◽  
Cross Sectional ◽  
Viral Loads ◽  
Testing Algorithms ◽  
Frequent Testing ◽  
Antigen Testing

Abstract Objectives Antigen based rapid diagnostic tests possesses a potential to be utilized along with Gold standard methods to detect Covid-19 infection to cope with the demand of testing. The aim of this study was to determine diagnostic accuracy of electrochemiluminescence based automated antigen detection immunoassay comparing with molecular based test RT-PCR (Covid-19). Methods It was a cross-sectional study conducted in RMI Peshawar, from 1st April 2021 till 30th April 2021. The study comprised 170 individuals who were suspected of having Covid-19. Nasopharyngeal samples taken from suspected individuals were analyzed by RT-PCR and automated antigen test (Elecsys SARS-CoV-2 Antigen) simultaneously. The correlation of SARS-CoV-2 antigen with PCR positive and negative cases was analyzed for specificity, sensitivity respectively. Results The ECLIA based Elecsys antigen test (Roche) revealed overall sensitivity 72%, specificity 95% and accuracy of 94.9%. Sensitivity of antigen test progressively declined from 94.3% in Ct <25 to 70.8% in Ct 26–29 and then to 47.2% in Ct 30–35. Conclusions Based on the findings of our study we conclude that automated antigen testing (Elecsys SARS-CoV-2 Antigen) cannot replace molecular based testing like RT PCR. Elecsys SARS-CoV-2 Ag test should be used complementary to RT-PCR in testing algorithms. Frequent testing strategy should be adopted while using automated antigen testing to overcome its limitation in individuals with low viral loads.

scholarly journals Pilot evaluation of risk assessment and enhanced protocols regarding contacts at an international professional golf event

2021 ◽  
Vol 7 (3) ◽  
pp. e001127
Author(s):  
Patrick G Robinson ◽  
Andrew Murray ◽  
Volker Sheer ◽  
Graeme Close ◽  
Denis F Kinane
Keyword(s):  
Risk Assessment ◽  
Pilot Study ◽  
High Risk ◽  
Disease Transmission ◽  
Low Risk ◽  
Contact Tracing ◽  
Sporting Events ◽  
Medical Surveillance ◽  
Rt Pcr ◽  
Antigen Testing

ObjectivesThe aim of this study was to assess whether a risk assessment and managed risk approach to contact tracing was practical and feasible at the Gran Canaria Lopesan Open 2021 and could inform further pilot work regarding disease transmission during elite sporting events.MethodsThis prospective cohort study included all international attendees. All participants required a minimum of one negative reverse transcriptase PCR (RT-PCR) test prior to travelling to each tournament. High-risk contacts were isolated for 10 days. Moderate-risk contacts received education regarding enhanced medical surveillance, had daily rapid antigen testing for 5 days, with RT-PCR day 5, mandated mask use and access to outside space for work purposes only. Low-risk contacts received rapid antigen testing every 48 hours and PCR testing on day 5.ResultsA total of 550 persons were accredited and were required to undergo RT-PCR testing before the event. Two of these tests were positive (0.36%). Of these, case 1 had 1 high, 23 moderate and 48 low-risk contacts. Case 2 did not have any significant travel history within 2 days of positive test and had one high-risk contact. There were no further positive tests on site in the wider cohort of attendees, from a total of 872 RT-PCR and 198 rapid antigen tests.ConclusionsThis pilot study showed it is practical, feasible and well accepted to provide enhanced (daily) virus testing and risk-mitigating measures at a professional golf event. Further study is required to assess the efficacy of these interventions; however, no transmission was found in this pilot study.

scholarly journals Direct Comparison of SARS Co-V-2 Nasal RT- PCR and Rapid Antigen Test (BinaxNOWTM) at a Community Testing Site During an Omicron Surge

2022 ◽  
Author(s):  
John Schrom ◽  
Carina Marquez ◽  
Genay Pilarowski ◽  
Grace Wang ◽  
Anthea Mitchell ◽  
...  
Keyword(s):  
San Francisco ◽  
High Viral Load ◽  
Antigen Test ◽  
Rt Pcr ◽  
Repeat Testing ◽  
Single Antigen ◽  
Testing Site ◽  
Antigen Testing ◽  
Test Result ◽  
Community Site

In 731 persons seeking COVID-19 testing at a walk-up San Francisco community site in January 2022, simultaneous nasal rapid antigen testing (BinaxNOWTM) and RT-PCR testing was performed. There were 296 (40.5%) positive tests by RT-PCR; 97% of a random sample were the omicron variant. Sensitivity of a single antigen test was 95.2% (95% CI 92-98%); 82.1% (95% CI 77-87%) and 65.2% (95% CI 60-70%) for Ct threshold of < 30, < 35 and no threshold, respectively. A single BinaxNowTM rapid antigen test detected 95% of high viral load omicron cases from nasal specimens. As currently recommended, repeat testing should be done for high- risk persons with an initial negative antigen test result.

scholarly journals How to best test suspected cases of COVID-19: an analysis of the diagnostic performance of RT-PCR and alternative molecular methods for the detection of SARS-CoV-2

2021 ◽  
Author(s):  
Adrian Mironas ◽  
David Jarrom ◽  
Evan Campbell ◽  
Jennifer Washington ◽  
Sabine Ettinger ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Test Performance ◽  
Clinical Utility ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Alternative Methods ◽  
Rt Pcr ◽  
Predictive Values ◽  
Molecular Assays ◽  
Test Result

AbstractAs COVID-19 testing is rolled out increasingly widely, the use of a range of alternative testing methods will be beneficial in ensuring testing systems are resilient and adaptable to different clinical and public health scenarios. Here, we compare and discuss the diagnostic performance of a range of different molecular assays designed to detect the presence of SARS-CoV-2 infection in people with suspected COVID-19. Using findings from a systematic review of 103 studies, we categorised COVID-19 molecular assays into 12 different test classes, covering point-of-care tests, various alternative RT-PCR protocols, and alternative methods such as isothermal amplification. We carried out meta-analyses to estimate the diagnostic accuracy and clinical utility of each test class. We also estimated the positive and negative predictive values of all diagnostic test classes across a range of prevalence rates. Using previously validated RT-PCR assays as a reference standard, 11 out of 12 classes showed a summary sensitivity estimate of at least 92% and a specificity estimate of at least 99%. Several diagnostic test classes were estimated to have positive predictive values of 100% throughout the investigated prevalence spectrum, whilst estimated negative predictive values were more variable and sensitive to disease prevalence. We also report the results of clinical utility models that can be used to determine the information gained from a positive and negative test result in each class, and whether each test is more suitable for confirmation or exclusion of disease. Our analysis suggests that several tests exist that are suitable alternatives to standard RT-PCR and we discuss scenarios in which these could be most beneficial, such as where time to test result is critical or, where resources are constrained. However, we also highlight methodological concerns with the design and conduct of many included studies, and also the existence of likely publication bias for some test classes. Our results should be interpreted with these shortcomings in mind. Furthermore, our conclusions on test performance are limited to their use in symptomatic populations: we did not identify sufficient suitable data to allow analysis of testing in asymptomatic populations.

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