scholarly journals Potential Use of Antigen-Based Rapid Test for SARS-CoV-2 in Respiratory Specimens in Low-Resource Settings in Egypt for Symptomatic Patients and High-Risk Contacts

2020 ◽  
Author(s):  
Abeer Mohamed Abdelrazik ◽  
Shahira Morsy Elshafie ◽  
Hossam M Abdelaziz

Abstract Objective Because of the rapidly emerging SARS-CoV-2 pandemic and its wide public health challenges, rapid diagnosis is essential to decrease the spread. Antigen-based rapid detection tests are available; however, insufficient data about their performance are available. Methods The lateral-flow immunochromatographic BIOCREDIT COVID-19 antigen test was evaluated using nasopharyngeal swabs in a viral transport medium from patients with confirmed infection, contacts, and exposed healthcare professionals at Fayoum University Hospital in Egypt. Test performance was determined in comparison to the SARS-CoV-2 real-time reverse-transcription polymerase chain reaction (RT-PCR) test. Results Three hundred ten specimens from 3 categories—patients with confirmed diagnoses of COVID-19, contacts, and exposed healthcare professionals—were included; 188 specimens were RT-PCR-positive, from which 81 were detected by rapid antigen test. Overall sensitivity was 43.1%. Sensitivity was significantly higher in specimens with high viral loads. Conclusion Poor sensitivity of the BIOCREDIT COVID-19 test does not permit its use for diagnosis, and it can only be used in conjunction with RT-PCR for screening.

Author(s):  
Mar Masiá ◽  
Marta Fernández-González ◽  
Manuel Sánchez ◽  
Mar Carvajal ◽  
José Alberto García ◽  
...  

Abstract Background Performance of point-of-care tests in different clinical scenarios and on different samples remains undetermined. We comprehensively evaluated the performance of the nasopharyngeal Panbio COVID-19 antigen Rapid-Test-Device. Method Prospective study including consecutive patients attending three primary care centers (PCC) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs, and in saliva. Positive and negative percent agreement (PPA, NPA) were calculated with the RT-PCR assay as reference standard. Results Of 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913, nasal swabs from 659, and saliva from 611 patients. RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall PPA (95% CI) in NPS was 60.5% (53.3-67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA of 94% for Ct≤25 and 80% for Ct<30. In symptomatic patients, the PPA was 95% for Ct≤25; 85% for Ct<30, and 89% for the symptom triad of fever, cough and malaise. Performance was also dependent on age, with PPA of 100% in symptomatic patients >50 years with Ct<25. In asymptomatic patients, the PPA was 86% for Ct<25. In all cases, NPA was 100%. Conclusion The nasopharyngeal Panbio COVID-19 antigen test performed at point-of-care has a good sensitivity in symptomatic patients with Ct<30 and older age. The test was useful to identify asymptomatic patients with lower Ct values.


Author(s):  
Anek Mungomklang ◽  
Nichapa Trichaisri ◽  
Jittima Jirachewee ◽  
Jaravee Sukprasert ◽  
Warut Tulalamba ◽  
...  

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a global pandemic. Therefore, rapid and accurate tests for SARS-CoV-2 screening are urgently needed to expedite disease prevention and control especially in community transmission. Since late December 2020, Thailand has faced a new wave of COVID-19 outbreaks. The Thai National Disease Control program at the Ministry of Public Health has identified suitable measure for mass screening. A SARS-CoV-2 antigen-based assay is a surveillance option for active cases. Here, we evaluated the feasibility and test performance of a rapid SARS-CoV-2 antigen test during our field activities in 1,100 asymptomatic individuals in Samut Sakhon, Thailand, during the second wave COVID-19 outbreak (December 26–30, 2020). The results showed that the rapid antigen test had a sensitivity of 47.97% (95% CI: 36.10–59.96%) and a specificity of 99.71% (95% CI: 99.15–99.94%) versus standard reverse-transcriptase polymerase chain reaction. The rapid test performed better in cases with higher viral loads determined by the cycle threshold value. In real-world setting, the test performance can be compromised by several factors including viral loads, logistic chains, temperature, technical expertise of the operators, validity, and accuracy of the testing itself. Our study highlights a prerequisite for reevaluation of any given testing before implementing it at the national level.


2020 ◽  
Vol 58 (9) ◽  
pp. 1573-1577 ◽  
Author(s):  
Nicola Clementi ◽  
Roberto Ferrarese ◽  
Marco Tonelli ◽  
Virginia Amato ◽  
Sara Racca ◽  
...  

AbstractObjectivesA milder clinical course of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been anecdotally reported over the latest phase of COVID-19 pandemic in Italy. Several factors may contribute to this observation, including the effect of lockdown, social distancing, lower humidity, lower air pollution, and potential changes in the intrinsic pathogenicity of the virus. In this regard, the clinical severity of COVID-19 could be attenuated by mutations in SARS-CoV-2 genome that decrease its virulence, as well as by lower virus inocula.MethodsIn this pilot study, we compared the reverse transcription polymerase chain reaction (RT-PCR) amplification profile of 100 nasopharyngeal swabs consecutively collected in April, during the peak of SARS-CoV-2 epidemic, to that of 100 swabs collected using the same procedure in May.ResultsThe mean Ct value of positive samples collected in May was significantly higher than that of samples collected in the previous period (ORF 1a/b gene: 31.85 ± 0.32 vs. 28.37 ± 0.5, p<0.001; E gene: 33.76 ± 0.38 vs. 29.79 ± 0.63, p<0.001), suggesting a lower viral load at the time of sampling. No significant differences were observed between male and females in the two periods, whilst higher viral loads were found in (i) patients over 60-years old, and (ii) patients that experienced severe COVID-19 during the early stages of the pandemic.ConclusionsThis pilot study prompts further investigation on the correlation between SARS-CoV-2 load and different clinical manifestation of COVID-19 during different phases of the pandemic. Laboratories should consider reporting quantitative viral load data in the molecular diagnosis of SARS-CoV-2 infection.


2021 ◽  
Vol 9 (4) ◽  
pp. 798
Author(s):  
Giorgia Caruana ◽  
Antony Croxatto ◽  
Eleftheria Kampouri ◽  
Antonios Kritikos ◽  
Onya Opota ◽  
...  

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.


2017 ◽  
Vol 33 (1) ◽  
pp. 8-15
Author(s):  
LR Barman ◽  
RD Sarker ◽  
BC Das ◽  
EH Chowdhury ◽  
PM Das ◽  
...  

A virological survey for avian influenza (AI) and Newcastle disease (ND) was conducted in two selected live bird markets (LBMs), namely Kaptan Bazar and Karwan Bazar in Dhaka city, Bangladesh from August 2011 to July 2012. A total of 513 dead chickens were collected. An immune-chromatographic rapid antigen test for Type A influenza virus and both conventional and real time RT-PCR were used for the detection and characterization of AI and ND viruses. All carcasses were first screened by the rapid antigen test kit and 93 were positive for Type A influenza virus. RT-PCR on a representative number of rapid antigen test positive samples (n = 24) confirmed the presence of Type A influenza virus and mostly H5 influenza virus (22 out of 24 tested samples). Influenza rapid test negative samples (n = 420) were subjected to routine necropsy. Heat stress, suffocation and physical injury were the most common cause of mortality (163 cases), followed by ND, suspected to be the cause of 85 deaths. On molecular investigation of these 85 samples, the presence of ND virus was confirmed in 59 and AI virus in 6; 15 were negative for both ND and AI viruses and 5 were unsuitable for investigation. Among the 59 ND confirmed cases 18 also contained AI virus. In summary, out of 513 carcasses 117 (22.81%) contained AI virus and 59 (11.50%) contained ND virus. Eighteen (3.51%) carcasses contained both AI and ND viruses. The findings suggest that both AI and ND should be considered as major threats to the poultry industry.Bangl. vet. 2016. Vol. 33, No. 1, 8-15


Author(s):  
Eliseo Albert ◽  
Ignacio Torres ◽  
Felipe Bueno ◽  
Dixie Huntley ◽  
Estefanía Molla ◽  
...  

AbstractWe evaluated the Panbio™ COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.


Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Bilal Iqbal ◽  
Maria Khan ◽  
Noman Shah ◽  
Mirza Muhammad Dawood ◽  
Valeed Jehanzeb ◽  
...  

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.


2021 ◽  
Author(s):  
Zannat Kawser ◽  
Mohabbat Hossain ◽  
Sara Suliman ◽  
Shahin Lockman ◽  
Jesse Gitaka ◽  
...  

Early detection of SARS-CoV-2 infection is crucial to prevent the spread of the virus. In this study, we evaluated the performance of a commercial rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against a gold-standard of nasopharyngeal (NP) swab tested by reverse transcription-polymerase chain reaction (RT-PCR) in prospectively recruited adults in Dhaka, Bangladesh. We compared the sensitivity and specificity of the two rapid antigen tests against RT-PCR results in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease-of-use of the BD Veritor test in a subsample of study participants (n=42) and implementers (n=5). The sensitivity of the BD Veritor rapid antigen 66 test was 70% in symptomatic (95% confidence interval [CI]: 51-85%) and 87% (95% CI: 69-96%) in asymptomatic individuals with positive SARSCoV-2 RT-PCR, for overall sensitivity of 78% (95% CI: 66-88%). The sensitivity of the Standard Q rapid antigen test was 63% (95% CI: 44-69 80%) in symptomatic and 73% (95% CI: 54-87%) in asymptomatic individuals. One false positive in BD Veritor test (specificity 99.5) and no false positive in Standard Q tests were observed (specificity 100%). The BD Veritor rapid antigen test was 78% sensitive when compared with RT-PCR irrespective of the cycle threshold (Ct) levels in this evaluation in Bangladesh. The implementation evaluation data showed good acceptability in the field settings. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.


Author(s):  
Manuel Linares ◽  
Ramón Pérez Tanoira ◽  
Juan Romanyk ◽  
Felipe Pérez García ◽  
Peña Gómez-Herruz ◽  
...  

Background: Real-time reverse transcription polymerase chain reaction (RT-qPCR) is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment, time consuming, high cost and skilled staff limit the use of these time-consuming molecular techniques. A more rapid and high-throughput method is in growing demand Methods: Evaluate the performances of the Panbio COVID-19 AG Rapid Test Device (Nasopharyngeal), a rapid immunochromatographic test for the detection of SARS-CoV-2 antigen, in comparison to RT-qPCR. Results: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads. Conclusions: This assay seems to be an effective strategy for controlling the COVID-19 pandemic for the rapid identification and isolation of SARS-CoV-2 infected patients.


2021 ◽  
Author(s):  
Jesse Gitaka ◽  
Eva Muthamia ◽  
Samuel Mbugua ◽  
Mary Mungai ◽  
Gama Bandawe ◽  
...  

Abstract Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS COV2, resulting in significant delays in treatment provision and commencement of outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor rapid antigen test as compared to the gold standard test for diagnosis of SARS COV2 in Kenya. Methods: This was a field test performance evaluation in symptomatic and asymptomatic adults undergoing testing for SARS COV2. Recruited participants were classified as SARS-CoV2-positive based on the locally implemented gold standard reverse transcription polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swabs. 272 antigen tests were performed with simultaneous gold standard testing, allowing us to estimate sensitivity, specificity, positive and negative predictive values for the BD Veritor rapid antigen test platform. Implementation characteristics were assessed using the Consolidated Framework for Implementation Research for feasibility, acceptability, turn-around time, and ease-of-use metrics. Results and Discussion: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to the gold standard, the sensitivity of the BD Veritor antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% confidence interval [CI] 96 to 100). The sensitivity of BD Veritor antigen test was higher among symptomatic (100%) compared to asymptomatic (84%) participants, although this difference was not statistically significant. There was also a lack of association between cycle threshold value and sensitivity of BD Veritor test. The BD Veritor test had quick turnaround time and minimal resource requirements, and laboratory personnel conducting testing felt that it was easier to use than the gold standard RT-PCR. Conclusion: The BD Veritor rapid antigen test exhibited excellent sensitivity and specificity when used to detect SARS-CoV-2 infection among both symptomatic and asymptomatic individuals in varied population settings in Kenya. It was feasible to implement and easy to use, with rapid turnaround time.


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