Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda

Bwogi, Josephine; Lutalo, Tom; Tushabe, Phionah; Bukenya, Henry; Eliku, James Peter; Ssewanyana, Isaac; Nabadda, Susan; Nsereko, Christopher; Cotten, Matthew; Downing, Robert; Lutwama, Julius J.; Kaleebu, Pontiano

doi:10.1371/journal.pone.0265334

Cited by 9 publications

(7 citation statements)

References 19 publications

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“…The RDTs included the COVID-19 Ag Respi-Strip, BIOCREDIT COVID-19 Ag, MEDsan1 SARS-CoV-2 Antigen Rapid test, PCL COVID19 Ag Rapid FIA, PanbioTM COVID-19 Ag Rapid test, Novegent COVID-19 Antigen Rapid test kit. Only the PanbioTM COVID-19 Ag Rapid Test meets the WHO performance requirements of 80% sensitivity and 97% specificity at qRT-PCR Ct levels of 29, and our RDT test results are comparable with this study [ 19 ].…”

Section: Discussionsupporting

confidence: 80%

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Evaluation of the diagnostic performance of PanbioTM Abbott SARS-CoV-2 rapid antigen test for the detection of COVID-19 from suspects attending ALERT center

Ashagre

Atnafu²,

Wassie³

et al. 2022

PLoS ONE

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Background The emergence and rapid spread of coronavirus disease 2019 (COVID-19), a potentially lethal disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is causing public health issues around the world. In resource-constrained nations, rapid Abbott SARS-CoV-2 antigen test kits are critical for addressing diagnostic gaps in health institutions and community screening. However, there is no evidence or proof of diagnostic performance in Ethiopia. The aim of this study was to compare the performance of PanbioTM Abbott SARS-CoV-2antigen rapid test kit to the gold standard, RT-PCR, in COVID-19 patients with clinical symptoms suggestive of COVID-19. Method A prospective, cross-sectional study was conducted between November 2021 and April 2022, on 120 suspected patients recruited from outpatient, emergency, and intensive care units in one of the tertiary hospitals in Ethiopia. Nasopharyngeal swabs were collected from suspected cases and were tested using the Abbott SARS-CoV-2 kit, a rapid diagnostic test (RDT) and compared to the reference standard RT-PCR. Result The sensitivity and specificity of the RDT were 74.2% and 100%, respectively. A total of 62 samples (51.6%) were RT-PCR positive. Of these, 46 were Ag-RDT positive. Sensitivity among symptomatic patients was 79.4% (95% CI 68.3–90). The Abbot RDT and RT-PCR had a Kappa value of agreement of 0.735 (p < 0.001). These values were acceptable when compared to the WHO’s suggested thresholds. Conclusion The finding from this study support the use of the Abbot RDT as a diagnostic tool in COVID-19 suspects, mainly in those with higher viral loads.

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Section: Discussionsupporting

confidence: 80%

“…In Uganda, one study compared the performance of seven Antigen Rapid Diagnostic Tests (RDTs) for the diagnosis of SARS-CoV-2 virus infection. The RDTs included the COVID- [19].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the diagnostic performance of PanbioTM Abbott SARS-CoV-2 rapid antigen test for the detection of COVID-19 from suspects attending ALERT center

Ashagre

Atnafu²,

Wassie³

et al. 2022

PLoS ONE

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“…Regarding BIOCREDIT CO-VID-19 Ag, one of the first studies compared the performance of this RAT to RT-PCR and viral cultures, showing that it detected only 11-45% of true positives [10]. A more recent study, performed on symptomatic and asymptomatic patients from isolation centers and on patients entered in Uganda, showed 59% accuracy, but low sensitivity in asymptomatic or low viral load patients (21% and 27%, respectively) [11]. A study, carried out on 119 symptomatic patients, showed BIOCREDIT COVID-19 sensitivity of 8%, advising against its use even beside RT-PCR [12].…”

Section: N Discussionmentioning

confidence: 99%

Are SARS-CoV-2 rapid antigen tests useful for the control of latest variants spreading?

et al. 2022

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Reverse Transcription Polymerase Chain Reaction (RT-PCR) conducted on nasopharyngeal swabs is the gold standard in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). In Italy, recent guidelines indicate that rapid antigen tests (RATs) can be used for the isolation of positive patients or for the interruption of quarantine, but they are often less sensitive to detect positive subjects. Indeed, the performance of these RATs depends on the timing and the population on which they are evaluated. Herein, we evaluated the performance of BIOCREDIT COVID-19 Ag and Fluo-SUMMARY recare ® SARS-CoV-2 Spike Protein Test during a population screening in the Calabria Region, Southern Italy. We report that both antigen test shows low sensitivity in contrast to the high sensitivity declared by manufacturer (90% and 92%, respectively) and that the area under the curve (AUC) was good for Fluorecare ® SARS-CoV-2 Spike Protein Test but very poor for BIOCREDIT COVID-19 Ag. We suggest that these RATs should be re-evaluated in the current pandemic era.

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“…Comparison analysis of the performance of several RATs, including BIOCREDIT COVID-19 Ag, in Uganda demonstrated that BIOCREDIT COVID-19 Ag had a specificity of ≥97% for the assessment of samples with a lower Ct value (≤29), and none of the evaluated RATs had a sensitivity of more than 80% at Ct values higher than 29 [ 48 ].…”

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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Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda

Cited by 9 publications

References 19 publications

Evaluation of the diagnostic performance of PanbioTM Abbott SARS-CoV-2 rapid antigen test for the detection of COVID-19 from suspects attending ALERT center

Evaluation of the diagnostic performance of PanbioTM Abbott SARS-CoV-2 rapid antigen test for the detection of COVID-19 from suspects attending ALERT center

Are SARS-CoV-2 rapid antigen tests useful for the control of latest variants spreading?

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

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