Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting

Bruzzone, Bianca; Pace, Vanessa De; Caligiuri, Patrizia; Ricucci, Valentina; Guarona, Giulia; Pennati, Beatrice Marina; Boccotti, Simona; Orsi, Andrea; Domnich, Alexander; Rin, Giorgio Da; Icardi, Giancarlo

doi:10.1016/j.ijid.2021.04.072

Cited by 28 publications

(31 citation statements)

References 12 publications

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“…The HG COVID assay satisfies these criteria. An assessment of several Ag-RDTs recently performed at our laboratory [27] showed overall sensitivity of 78.7% (95% CI: 73.2-83.3%); this, however, varied significantly by Ct value and brand. We concluded that Ag-RDTs are convenient for screening purposes in moderate-to-high intensity settings [27].…”

Section: Discussionmentioning

confidence: 88%

Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

et al. 2021

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Although the reverse transcription-polymerase chain reaction (RT-PCR) is considered a standard-of-care assay for the laboratory diagnosis of SARS-CoV-2, several limitations of this method have been described. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is an alternative molecular assay and is potentially able to overcome some intrinsic shortcomings of RT-PCR. In this study, we evaluated the diagnostic performance of the novel HG COVID-19 RT-LAMP assay. In this retrospective analysis, a total of 400 routinely collected leftover nasopharyngeal samples with a known RT-PCR result were tested by means of the HG COVID-19 RT-LAMP assay. The overall sensitivity and specificity values of HG COVID-19 RT-LAMP versus RT-PCR were 97.0% (95% CI: 93.6–98.9%) and 98.5% (95% CI: 95.7–99.7%), respectively. Inter-assay agreement was almost perfect (κ = 0.96). Concordance was perfect in samples with high viral loads (cycle threshold < 30). The average time to a positive result on RT-LAMP was 17 min. HG COVID-19 RT-LAMP is a reliable molecular diagnostic kit for detecting SARS-CoV-2, and its performance is comparable to that of RT-PCR. Shorter turnaround times and the possibility of performing molecular diagnostics in the point-of-care setting make it a valuable option for facilities without sophisticated laboratory equipment.

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Section: Discussionmentioning

confidence: 88%

Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

et al. 2021

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“…The HG COVID assay satis es these criteria. An assessment of several Ag-RDTs recently performed at our laboratory [30] showed overall sensitivity of 78.7% (95% CI: 73.2-83.3%); this, however, varied signi cantly by Ct value and brand. We concluded that Ag-RDTs are convenient for screening purposes in moderate-to-high intensity settings [30].…”

Section: Discussionmentioning

confidence: 89%

“…An assessment of several Ag-RDTs recently performed at our laboratory [30] showed overall sensitivity of 78.7% (95% CI: 73.2-83.3%); this, however, varied signi cantly by Ct value and brand. We concluded that Ag-RDTs are convenient for screening purposes in moderate-to-high intensity settings [30]. In the present study, the analytical performance of the HG COVID-19 assay was comparable to that of RT-PCR; the assay may therefore be an alternative molecular diagnostic tool for SARS-CoV-2 detection, independently of the purpose and the viral epidemiology.…”

Section: Discussionmentioning

confidence: 89%

High diagnostic performance of a novel reverse transcription loop-mediated isothermal amplification (RT-LAMP) kit for the rapid detection of SARS-CoV-2

Domnich

Orsi

Panatto

et al. 2021

Preprint

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Although the reverse transcription polymerase chain reaction (RT-PCR) is considered a standard-of-care assay for the laboratory diagnosis of SARS-CoV-2, several limitations of this method have been described. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is an alternative molecular assay and is potentially able to overcome some intrinsic shortcomings of RT-PCR. In this study, we evaluated the diagnostic performance of the novel HG COVID-19 RT-LAMP assay. In this retrospective analysis, a total of 400 routinely collected leftover nasopharyngeal samples with a known RT-PCR result were tested by means of the HG COVID-19 RT-LAMP assay. The overall sensitivity and specificity values of HG COVID-19 RT-LAMP versus RT-PCR were 97.0% (95% CI: 93.6–98.9%) and 98.5% (95% CI: 95.7–99.7%), respectively. Inter-assay agreement was almost perfect (κ = 0.96). Concordance was perfect in samples with high viral loads (cycle threshold <30). The average time to a positive result on RT-LAMP was 17 min. HG COVID-19 RT-LAMP is a reliable molecular diagnostic kit for detecting SARS-CoV-2, and its performance is comparable to that of RT-PCR. Shorter turnaround times and the possibility of performing molecular diagnostics in the point-of-care setting make it a valuable option for facilities without sophisticated laboratory equipment.

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“…155 Bruzzone et al have quantified the performance of seven different available types of antigendetecting rapid diagnostic tests compared with RT-qPCR, and the results showed that the overall sensitivity and specificity of antigen tests were 78.7% and 100%, respectively, and a wide range of sensitivity of different brands (66.0-93.8%) was observed. 156 Therefore, further investigations and confirmatory studies are needed for the validation of different antigendetection kits.…”

Section: Antigen Testingmentioning

confidence: 99%

Applications of laboratory findings in the prevention, diagnosis, treatment, and monitoring of COVID-19

Meng

Guo

Zhou

et al. 2021

Sig Transduct Target Ther

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The worldwide pandemic of coronavirus disease 2019 (COVID-19) presents us with a serious public health crisis. To combat the virus and slow its spread, wider testing is essential. There is a need for more sensitive, specific, and convenient detection methods of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Advanced detection can greatly improve the ability and accuracy of the clinical diagnosis of COVID-19, which is conducive to the early suitable treatment and supports precise prophylaxis. In this article, we combine and present the latest laboratory diagnostic technologies and methods for SARS-CoV-2 to identify the technical characteristics, considerations, biosafety requirements, common problems with testing and interpretation of results, and coping strategies of commonly used testing methods. We highlight the gaps in current diagnostic capacity and propose potential solutions to provide cutting-edge technical support to achieve a more precise diagnosis, treatment, and prevention of COVID-19 and to overcome the difficulties with the normalization of epidemic prevention and control.

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Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting

Cited by 28 publications

References 12 publications

Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

High diagnostic performance of a novel reverse transcription loop-mediated isothermal amplification (RT-LAMP) kit for the rapid detection of SARS-CoV-2

Applications of laboratory findings in the prevention, diagnosis, treatment, and monitoring of COVID-19

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