scholarly journals Comparative Sensitivity of Rapid Antigen Tests for the Delta Variant (B.1.617.2) of SARS-CoV-2

Viruses ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2183
Author(s):  
Yuko Sakai-Tagawa ◽  
Seiya Yamayoshi ◽  
Peter J. Halfmann ◽  
Yoshihiro Kawaoka

Rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are useful for rapid diagnosis in a variety of settings. Although many kinds of RATs are available, their respective sensitivity has not been compared. Here, we examined the sensitivity of 27 RATs available in Japan for the detection of the SARS-CoV-2 delta variant. All of the RATs tested detected the delta variant albeit with different sensitivities. Nine RATs (ESPLINE SARS-CoV-2, ALSONIC COVID-19 Ag, COVID-19 and Influenza A+B Antigen Combo Rapid Test, ImmunoArrow SARS-CoV-2, Fuji Dri-chem immuno AG cartridge COVID-19 Ag, 2019-nCoV Ag rapid detection kit, Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit, and Rabliss SARS-CoV-2 antigen detection kit COVID19 AG) showed superior sensitivity to the isolated delta variant. Although actual clinical specimens were not examined, the detection level of most of the RATs was 7500 pfu, indicating that individuals whose test samples contained less virus than that would be considered negative. Therefore, it is important to bear in mind that RATs may miss individuals shedding low levels of infectious virus.

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
David R. McIlwain ◽  
Han Chen ◽  
Maria Apkarian ◽  
Melton Affrime ◽  
Bonnie Bock ◽  
...  

Abstract Background Influenza places a significant burden on global health and economics. Individual case management and public health efforts to mitigate the spread of influenza are both strongly impacted by our ability to accurately and efficiently detect influenza viruses in clinical samples. Therefore, it is important to understand the performance characteristics of available assays to detect influenza in a variety of settings. We provide the first report of relative performance between two products marketed to streamline detection of influenza virus in the context of a highly controlled volunteer influenza challenge study. Methods Nasopharyngeal swab samples were collected during a controlled A/California/2009/H1N1 influenza challenge study and analyzed for detection of virus shedding using a validated qRT-PCR (qPCR) assay, a sample-to-answer qRT-PCR device (BioMerieux BioFire FilmArray RP), and an immunoassay based rapid test kit (Quidel QuickVue Influenza A + B Test). Results Relative to qPCR, the sensitivity and specificity of the BioFire assay was 72.1% [63.7–79.5%, 95% confidence interval (CI)] and 93.5% (89.3–96.4%, 95% CI) respectively. For the QuickVue rapid test the sensitivity was 8.5% (4.8–13.7%, 95% CI) and specificity was 99.2% (95.6–100%, 95% CI). Conclusion Relative to qPCR, the BioFire assay had superior performance compared to rapid test in the context of a controlled influenza challenge study.


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


2019 ◽  
Vol 07 (02) ◽  
pp. E268-E273 ◽  
Author(s):  
Harminder Singh ◽  
Donald Duerksen ◽  
Gale Schultz ◽  
Carol Reidy ◽  
Pat DeGagne ◽  
...  

Abstract Background and study aims Prevention of infection transmission from contaminated endoscopes would benefit from a rapid test that could detect low levels of viable bacteria after high level disinfection. The aim of this study was to evaluate the rapid NOW! (RN) test’s ability to detect endoscope contamination. Materials and methods The RN test kit and the accompanying fluorometer were evaluated. The manufacturer states that a fluorometer signal > 300 units is indicative of viable Gram-negative bacteria. Suspension testing of varying concentrations of Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis were used to determine the RN test limit of detection. Simulated-use testing was done using a duodenoscope inoculated with 10 % blood containing approximately 35 CFU E. coli per channel. Samples were extracted from the duodenoscope instrument channel and tested using the manufacturer’s instructions. Results The RN test could consistently detect 10 CFU of E. coli and P. aeruginosa (fluorescent signal of 9,000 to 11,000 units) but not E. faecalis. Sensitivity and specificity for Gram-negative bacteria were 93 % and 90 %, respectively, using all of the suspensions in the study. Extraction of E. coli from an inoculated duodenoscope instrument channel repeatedly provided a positive signal (i. e. > 2,000 units). Conclusions The RN test can reliably detect low levels of Gram-negative bacteria in suspension as well as from samples extracted from endoscope channels. These preliminary findings are encouraging but further assessment of extraction efficacy, impact of organic residuals and clinical workflow are still needed.


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):  
Retno Handajani ◽  
Mochammad Thaha ◽  
Mochamad Amin ◽  
Citrawati Dyah Kencono Wungu ◽  
Edhi Rianto ◽  
...  

Anti-Human Immunodeficiency Virus (Anti-HIV) was performed from 100 plasma Chronic Kidney Disease (CKD) stage 5 patientswith continuous hemodialysis (HD) at the Hemodialysis Instalation Dr Soetomo hospital, Surabaya, Indonesia, using three (3) kind ofreagents: Tri-line HIV Rapid test Device from Acon for HIV 1/2/O as strips form, Foresight HIV 1/2/O Antibody EIA Test Kit from Aconand Anti-HIV 1+2/Subtype O ELISA from Axiom. HIV RNA and HIV subtype were detected by Reverse Transcription Polymerase ChainReaction (RT-PCR) based on HIV gag region and analysis of DNA result. Seventy three % patients were hemodialysed twice in a week andonly 14% with duration more than five (5) years. Most of the patients (43%) were hemodialysed between 100−300 times. From the 100plasma samples was obtained only one (1%) man patient plasma sample with positive anti-HIV. A weak positive of RT-PCR result wasnot succeed to be sequenced for determining the HIV subtype. This cause was suspected due to low levels of HIV RNA in blood. The resultsof this study was expected can be used as an additional management consideration of hemodialysis patients at the Hemodialysis Unit.


2020 ◽  
Author(s):  
David R. McIlwain ◽  
Han Chen ◽  
Maria Apkarian ◽  
Melton Affrime ◽  
Bonnie Bock ◽  
...  

Abstract Background: Influenza places a significant burden on global health and economics. Individual case management and public health efforts to mitigate the spread of influenza are both strongly impacted by our ability to accurately and efficiently detect influenza viruses in clinical samples. Therefore, it is important to understand the performance characteristics of available assays to detect influenza in a variety of settings. We provide the first report of relative performance between two products marketed to streamline detection of influenza virus in the context of a highly controlled volunteer influenza challenge study. Methods: Nasopharyngeal swab samples were collected during a controlled A/California/2009/H1N1 influenza challenge study and analyzed using for detection of virus shedding using a validated qRT-PCR (qPCR) assay, a sample-to-answer qRT-PCR device (BioMerieux BioFire FilmArray RP), and an immunoassay based rapid test kit (Quidel QuickVue Influenza A+B Test).Results: Relative to qPCR, the sensitivity and specificity of the BioFire assay was 72.1% (63.7%-79.5%, 95% Confidence Interval (CI)) and 93.5% (89.3%-96.4%, 95% CI) respectively. For the QuickVue rapid test the sensitivity was 8.5% (4.8%-13.7%, 95% CI) and specificity was 99.2% (95.6%-100%, 95% CI).Conclusion: Relative to qPCR, the BioFire assay had superior performance compared to rapid test in the context of a controlled influenza challenge study.


2007 ◽  
Vol 14 (8) ◽  
pp. 1050-1052 ◽  
Author(s):  
Young Yoo ◽  
Jang Wook Sohn ◽  
Dae Won Park ◽  
Jeong Yeon Kim ◽  
Hye Kyung Shin ◽  
...  

ABSTRACT The performance of the SD Bioline rapid antigen test kit for influenza virus detection was evaluated with 295 respiratory specimens during the influenza season. The overall sensitivity and specificity of the SD Bioline test were 61.9% and 96.8% for the influenza A virus antigen and 54.5% and 100% for the influenza B virus antigen, respectively. The results were consistent with peak influenza activities.


Viruses ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1420
Author(s):  
Seiya Yamayoshi ◽  
Yuko Sakai-Tagawa ◽  
Michiko Koga ◽  
Osamu Akasaka ◽  
Ichiro Nakachi ◽  
...  

Reverse transcription-quantitative PCR (RT-qPCR)-based tests are widely used to diagnose coronavirus disease 2019 (COVID-19). As a result that these tests cannot be done in local clinics where RT-qPCR testing capability is lacking, rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are used for rapid diagnosis. However, their sensitivity compared with each other and with RT-qPCR and infectious virus isolation has not been examined. Here, we compared the sensitivity among four RATs by using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) isolates and several types of COVID-19 patient specimens and compared their sensitivity with that of RT-qPCR and infectious virus isolation. Although the RATs read the samples containing large amounts of virus as positive, even the most sensitive RAT read the samples containing small amounts of virus as negative. Moreover, all RATs tested failed to detect viral antigens in several specimens from which the virus was isolated. The current RATs will likely miss some COVID-19 patients who are shedding infectious SARS-CoV-2.


2021 ◽  
Author(s):  
Marie Thérèse Ngo Nsoga ◽  
Ilona Kronig ◽  
Francisco Javier Perez Rodriguez ◽  
Pascale Sattonnet-Roche ◽  
Diogo Da Silva ◽  
...  

AbstractBackgroundAntigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients.MethodsWe conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS.Results402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2-86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a specificity of 99.1% (95%CI: 96.9-99.9) for the Ag-RDT.For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7-99.0%) was obtained with the Ag-RDT using OPS.InterpretationBased on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples meet the criteria required by the WHO for Ag-RDTs (sensitivity≥80% and specificity ≥97%).


Author(s):  
Pavel Drevinek ◽  
Jakub Hurych ◽  
Zdenek Kepka ◽  
Ales Briksi ◽  
Michal Kulich ◽  
...  

AbstractObjectivesAntigen tests have recently emerged as an interesting alternative to SARS-CoV-2 diagnostic PCR, thought to be valuable especially for the screening of bigger communities. To check appropriateness of the antigen based testing, we determined sensitivity of two point-of-care antigen tests when applied to a cohort of COVID-19 symptomatic, COVID-19 asymptomatic and healthy persons.MethodsWe examined nasopharyngeal swabs with antigen test 1 (Panbio Covid-19 Ag Rapid Test, Abbott) and antigen test 2 (Standard F Covid-19 Ag FIA, SD Biosensor). An additional nasopharyngeal and oropharyngeal swab of the same individual was checked with PCR (Allplex SARS-nCoV-2, Seegene). Within a 4-day period in October 2020, we collected specimens from 591 subjects. Of them, 290 had COVID-19 associated symptoms.ResultsWhile PCR positivity was detected in 223 cases, antigen test 1 and antigen test 2 were found positive in 148 (sensitivity 0.664, 95% CI 0.599 - 0.722) and 141 (sensitivity 0.623, 95% CI 0.558 - 0.684) patients, respectively. When only symptomatic patients were analysed, sensitivity increased to 0.738 (95% CI 0.667 - 0.799) for the antigen test 1 and to 0.685 (95% CI 0.611 - 0.750) for the antigen test 2. The substantial drop in sensitivity to 12.9% (95% CI 0.067 - 0.234) was observed for samples with the PCR threshold cycle above > 30.ConclusionsLow sensitivity of antigen tests leads to the considerable risk of false negativity. It is advisable to implement repeated testing with high enough frequency if the antigen test is used as a frontline screening tool.


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