SARS‐CoV‐2 rapid antigen test in comparison to RT‐PCR targeting different genes: A real‐life evaluation among unselected patients in a regional hospital of Italy

Treggiari, Davide; Piubelli, Chiara; Caldrer, Sara; Mistretta, Manuela; Ragusa, Andrea; Orza, Pierantonio; Pajola, Barbara; Piccoli, Donatella; Conti, Antonio; Lorenzi, Cristina; Serafini, Valentina; Boni, M; Perandin, Francesca

doi:10.1002/jmv.27378

Cited by 18 publications

(16 citation statements)

References 17 publications

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Section: Discussionmentioning

confidence: 49%

“…Studies carried out in hospital settings, have reported higher sensitivity for the RAT than reported by us [ 21 , 22 ]. For instance, a study carried out in hospital setting in Italy has shown higher PPV and NPV values for RAT than reported by us, with higher sensitivity rates [ 21 ]. Another study in a Swiss University hospital also reported a sensitivity of 65.3% for the SD-Biosensor RAT, which was higher than the 36.5% sensitivity reported by us [ 22 ].…”

Section: Discussionmentioning

confidence: 49%

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Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

et al. 2022

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Background SARS-CoV-2 rapid antigen (Ag) detection kits are widely used in addition to quantitative reverse transcription PCR PCR (RT-qPCR), as they are cheaper with a rapid turnaround time. As there are many concerns regarding their sensitivity and specificity, in different settings, we evaluated two WHO approved rapid Ag kits in a large cohort of Sri Lankan individuals. Methods Paired nasopharangeal swabs were obtained from 4786 participants for validation of the SD-Biosensor rapid Ag assay and 3325 for the Abbott rapid Ag assay, in comparison to RT-qPCR. A short questionnaire was used to record symptoms at the time of testing, and blood samples were obtained from 2721 of them for detection of SARS-CoV-2 specific antibodies. Results The overall sensitivity of the SD-Biosensor Ag kit was 36.5% and the Abbott Ag test was 50.76%. The Abbott Ag test showed specificity of 99.4% and the SD-Biosensor Ag test 97.5%. At Ct values < 25, the sensitivity was 71.3% to 76.6% for the SD-Biosensor Ag test and 77.3% to 88.9% for the Abbott Ag test. The Ct values for all genes (RdRP, S, E and N) tested with all RT-qPCR kits were significantly lower for the positive results of the Abbott Ag test compared to the SD-Biosensor test. 209 (48.04%) individuals who had antibodies gave a positive RT-qPCR result, and antibody positivity rates were higher at Ct values > 30 (46.1 to 82.9%). 32.1% of those who gave a positive result with the SD-Biosensor Ag test and 26.3% of those who gave positive results with the Abbott Ag test had SARS-CoV-2 antibodies at the time of detection. Conclusions Both rapid Ag tests appeared to be highly sensitive in detecting individuals at lower Ct values, in a community setting in Sri Lanka, but it will be important to further establish the relationship to infectivity.

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Section: Discussionmentioning

confidence: 49%

Section: Discussionmentioning

confidence: 49%

Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

et al. 2022

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“…In larger study populations, Panbio sensitivity was between 33.3% ( 18 ) and 55.3% ( 19 ) in asymptomatic patients. Wagenhäuser et al described an overall sensitivity of 46.7% ( 20 ), meanwhile, Treggiari et al found the overall sensitivity at 66.8% ( 21 ).…”

Section: Discussionmentioning

confidence: 99%

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

et al. 2022

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Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Rapid Antigen Detection Testing (RADT) has been subjected to several evaluations in reference to diagnostic accuracy, ranging from small scale up to large population studies including nation-wide community-based studies. All confirmed the diagnostic accuracy of the tests which were strongly dependent upon the infection's population prevalence. In our retrospective study, parallel SARS-CoV-2 Panbio™ RADT assay, including real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) tests, were aimed to evaluate diagnostic performance regarding the rapid antigen diagnostic testing. Out of 4,440 paired tests, 609 samples tested positive using RT-qPCR, resulting in a prevalence of 13.7%. Panbio detected 251 (5.7%) positive tested samples. Overall sensitivity was 41.2% (95% CI 37.4–45.2%) and overall specificity was 99.7% (95% CI 99.4–99.8%). Positive predictive value (PPV) was 95.1% (95% CI 91.8–97.1%) and the negative predictive value (NPV) was 91.4% (95% CI 90.5–92.2%). RADT sensitivity increased with stratification in reference to the results according to PCR Cycle threshold (Ct) and presence of the symptoms considerably influenced PPV and NPV. Sensitivity in the group of Ct values ≤ 20 was 91.2%, 68.6% within the Ct range of 20–25, 47.9% in the group of Ct values between 25 and 30, and 12.6% in the group of Ct values between 30 and 35. A follow-up of the positive cases aligned with RT-qPCR testing and comparison of the general population enrolled in the testing in which the fatal cases occurred enabled us to estimate real clinical diagnostic performance regarding the SARS-CoV-2 Panbio RADT. Based upon our results, we recommend the SARS-CoV-2 Panbio RADT tests be carried out as the primary test, without parallel PCR testing, only among high population prevalence rates of the infection and to be used for symptomatic individuals with average or low severe disease developmental risk. In the case of high risk regarding the development of severe infection complications, a parallel SARS-CoV-2 RT-qPCR is needed to be carried out to attain proper diagnostic accuracy and avoid delaying appropriate medical care.

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“…Statistically significant results were obtained between positive and negative rapid antigen test when compared with C q values of individual target genes obtained from RT-PCR. A study conducted by Tregiarri et al too demonstrated the statistically significant result ( p < 0.001) when Ag-RDT data were compared to that of C q values obtained [ 41 ].…”

Section: Discussionmentioning

confidence: 99%

Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in relation to RT-PCR Cq Value

Mandal

Bhattarai

Pokhrel

et al. 2022

Advances in Virology

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Background. Early detection of the SARS-CoV-2 is crucial for both the improvement of turnaround time and limiting the spread of the virus in the community. Thus, this study aims to establish rapid antigen tests as an effective diagnostic tool to improve the testing strategies of COVID-19 diagnosis. Methods. A laboratory based cross-sectional study was performed on the patients that visited Sukraraj Tropical and Infectious Disease Hospital (STIDH) in Kathmandu, Nepal, from November 2020 to January 2021. A total of 213 nasopharyngeal swabs were collected from both symptomatic and asymptomatic patients for rapid antigen test, followed by RT-PCR assay as reference test for confirmation of COVID-19. A standard questionnaire was administered to collect other information from patients. Data were collected and analyzed using SPSS version 20. Results. Out of 213 individuals, 75 tested positive in Ag-RDT test, while 118 tested positive for SARS-CoV-2 RNA genome via Real time PCR assay. The overall diagnostic performance of Ag-RDT showed 63.6% sensitivity and 97.9% specificity. The diagnostic accuracy of Ag- RDT was 78.9% with κ value 0.590, showing moderate agreement with RT-PCR. Significant difference ( p value <0.001) was observed between Ag- RDT+ and Ag- RDT− results when compared to Cq values obtained from RT- PCR. Conclusion. The promising performance of Ag-RDT renders it useful as screening tool alongside RT-PCR to reduce transmission via improving contact tracing, implementation of local mitigation strategies, and refining existing testing protocol for diagnosis of COVID-19.

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SARS‐CoV‐2 rapid antigen test in comparison to RT‐PCR targeting different genes: A real‐life evaluation among unselected patients in a regional hospital of Italy

Cited by 18 publications

References 17 publications

Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in relation to RT-PCR Cq Value

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